A Clinical Study With the Carry Life® UF System in Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
Phase: NA
Conditions: End Stage Renal Disease
Sponsor: Triomed AB

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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CONFIDENTIAL 
CLINICAL INVESTIGATION PLAN (CIP) 
 
 
Study Title  
A clinical study with the Carry Life® UF system in continuous 
ambulatory peritoneal dialysis (CAPD) patients 
Study No. 
Tmed-010 
EUDAMED No. 
CIV-23-03-042555 
Clinical Investigation  
Medical Device(s) 
Carry Life® UF system 
Indication 
Peritoneal dialysis and ultrafiltration in end-stage kidney 
disease (ESKD) patients 
Class 
Carry Life® UF Cycler: Class IIb, Rule 12 per MDR 2017/745 
Carry Life® UF Line set: Class IIa, Rule 2 per MDR 2017/745 
Document Version 
V6.0 
Issue Date 
Feb 08  2024 
Coordinating Investigator Dr Olof Heimburger, Chief Physician  
Mottagning Njurmedicin Rosenlund  
Karolinska Universitetssjukhuset 
Tideliusgatan 12, 118 69 Stockholm, Sweden 
Investigators and 
Investigation Sites  
A list of investigators, investigation sites, and external 
organizations involved with this clinical investigation is found in 
Attachment A. An up-to-date list will be maintained by the 
Sponsor. The final list will be provided with the Clinical 
Investigation Report. 
Sponsor 
Triomed AB 
Scheelevägen 20, 223 63 Lund, Sweden 
 
 
 
CONFIDENTIAL 
This Clinical Investigation Plan (CIP) contains privileged or confidential information, which is the property of 
Triomed AB. Information may not be disclosed to a third party without written authorization from Triomed AB. 
 
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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1 SYNOPSIS 
 
STUDY TITLE 
A clinical study with the Carry Life® UF system in continuous ambulatory peritoneal 
dialysis (CAPD) patients 
STUDY TYPE 
Pre-market, prospective, multicenter, randomized, crossover study. 
STUDY SITES  
Six (6) to twelve (12) European sites will participate in this clinical investigation.  
STUDY PERIOD 
Estimated time for clinical investigation completion: Approximately one (1) year. 
Participation of each study subject: Approximately twelve (12) weeks.  
OBJECTIVES 
Primary objective: To demonstrate that a 5-hour Carry Life® UF treatment at home 
results in an increased ultrafiltration (UF) volume compared to a 5-hour 2.27% glucose 
CAPD dwell in adult CAPD patients. 
 
Secondary objectives:  
• 
To evaluate the overall safety of the Carry Life® UF system used by the patient 
at home as measured by rates of adverse events (AEs) and serious adverse 
events (SAEs) in adult CAPD patients. 
• 
To demonstrate that treatment with the Carry Life® UF system at home results 
in increased sodium removal compared to a 2.27% glucose CAPD dwell in adult 
CAPD patients. 
• 
To demonstrate that treatment with Carry Life® UF system at home results in a 
more glucose efficient peritoneal fluid removal compared to a 2.27% glucose 
CAPD dwell in adult CAPD patients. 
• 
To evaluate if the peak glucose concentration during a Carry Life® UF treatment 
is lower than the glucose concentration of a 2.27% glucose peritoneal dialysis 
(PD) solution. 
 
Exploratory objectives:  
• 
Evaluation of peritoneal urea and creatinine removal. 
• 
Evaluation of overall weekly UF volumes based on the patient diary. 
ENDPOINTS 
Primary endpoint:  
• 
UF volume during treatments at home (Carry Life® UF treatment vs. a 2.27% 
glucose CAPD dwell).  
 
Secondary endpoints:  
• 
AE and SAE rates.  
• 
Peritoneal sodium removal. 
• 
Glucose UF efficiency. 
• 
Peak dialysate glucose concentration. 
 
Exploratory endpoints: 
• 
Peritoneal creatinine and urea removal. 
• 
Weekly UF volumes. 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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METHODOLOGY 
The study consists of the following five (5) phases: 
1. Inclusion phase. 
2. In-clinic treatment phase for dose determination and safety evaluation. 
3. Randomization phase. 
4. Transition to home treatment phase. 
5. Home treatment phase for efficacy and safety evaluation.  
 
CAPD patients need to use the Baxter PD system and have a PD prescription of at least 
one 1.5-2.0 L 2.27% glucose day dwell to be included in the study. Throughout the study, 
the subject will use the fill volume they normally use, both for the standard PD 
prescription and for the Carry Life® UF treatments. However, for the peritoneal 
equilibrium test (PET), a 2 L fill volume will be used. 
 
The in-clinic phase consists of one 2.27% CAPD dwell and two Carry Life® UF treatments; 
one with a 11 g/h glucose dose and one with a 15 g/h glucose dose. The Carry Life® UF 
treatments will be used for a safety evaluation and based on the UF volumes achieved 
with the Carry Life® UF treatments, the Carry Life® UF glucose dose for the home 
treatment phase will be determined. 
 
After completion of the in-clinic treatment phase, subjects will be randomized to start 
the home treatment phase either with the control treatment arm or with the Carry Life® 
UF treatment arm. Subjects in the control arm will continue their standard CAPD 
treatment as prescribed. In the Carry Life® UF arm, for three days of the week one 2.27% 
glucose CAPD dwell per day will be replaced by a Carry Life® UF treatment. For the 
remaining four days of the week, one 2.27% glucose CAPD dwell will be replaced with a 
1.36% glucose CAPD dwell.  
 
Immediately before the subject starts using the Carry Life® UF device at home, there will 
be a transition to the home treatment phase during which the patient will be trained in 
how to use the Carry Life ® UF system. 
 
AEs, SAEs, and Carry Life® UF device malfunctions will be recorded throughout the study. 
A nurse at each participating clinic who has undergone education and training necessary 
for thorough AE collection will be responsible for the recording of AEs i.e., education in 
Good Clinical Practice (GCP) will be required and training with respect to the electronic 
case record form (eCRF) for AE reporting. In case of an AE or Carry Life® UF device 
malfunction during the home phase, the subject will be instructed to immediately 
contact the clinic. Furthermore, the clinic will contact the subject weekly and specifically 
ask about the occurrence of any AE or Carry Life® UF device malfunction.  
 
Any changes in medications or PD prescriptions will be recorded during the study. If 
changes to diuretic prescription or PD prescription are made, the reason for the change 
will be documented. If a study participant discontinues the clinical study the reason for 
this will be documented in detail. 
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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A flow diagram of the study design is shown below (Figure 1). Refer to Table 1 for the 
schedule of activities at each visit.  
 
Figure 1. Study flow chart 
 
Abbreviations: CLUF = Carry Life® UF; Grp. = Group; PET = peritoneal equilibration test; 
Screen. = Screening; T = Transition to home phase with device training.  
* A run-in period of at least two weeks may be performed in order to make an approved 
adjustment the PD prescription so that it can meet the study inclusion criteria 
STUDY FOLLOW UP 
The subject will be followed up for one (1) week for new or continuing AEs after the 
end-of-study visit. The follow-up will be in the form of a phone call or a physical meeting 
as required. 
NUMBER OF SUBJECTS  
Approximately 25 patients will be enrolled with a goal of 19 completing the study per 
protocol. 
STUDY POPULATION 
Adult subjects with end-stage kidney disease (ESKD) treated with CAPD. 
INCLUSION/EXCLUSION 
CRITERIA 
Inclusion criteria 
1. Age ≥ 18 years. 
2. Subjects with ESKD treated with PD for at least three (3) months. 
3. A PD prescription of 2–4 CAPD dwells/day unchanged for a minimum of two (2) 
weeks, with at least one 1.5–2L, 2.27% glucose day dwell daily. 
4. Subjects must be able to tolerate a 2 L PD fill volume for the PET. 
5. Subjects using the Baxter PD system with a MiniCap transfer set. 
6. In the opinion of the Investigator, the subject has the capacity to learn how to 
use the Carry Life® UF system or has a caregiver who can do so. 
7. Obtained written consent to participate in the study. 
 
Exclusion criteria 
1. A PD prescription including a regular 3.86% glucose day dwell. 
2. An episode of peritonitis within the last three (3) months. 
3. Serum potassium > 6 mmol/l within the last three (3) months. 
4. Serum urea > 35 mmol/l within the last three (3) months. 
5. Clinical signs of dehydration. 
6. Systolic blood pressure < 100 mmHg within the last month. 
7. Known diagnosis of clinically significant aortic stenosis. 
8. Clinical condition of unstable diabetes. 
9. Subjects with a life expectancy of < six (6) months. 
10. Evidence of any other diseases or medical conditions that may interfere with the 
planned treatment or affect participant compliance. 
*

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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11. Participation in clinical trials, interfering with the present study, within the 
previous month. 
12. Anticipated living donor kidney transplantation within six (6) months of 
screening. 
13. Pregnant, breastfeeding, or women of childbearing potential who are not using 
an effective method of contraception (hormonal contraceptives or barrier 
contraceptive methods). 
INDICATIONS FOR USE 
The Carry Life® UF system is indicated for PD and UF in adult patients with ESKD.  
DURATION OF 
TREATMENT 
Each subject’s participation will last approximately 12 weeks. The study schedule will 
include 8 to 13 visits depending on the individual device training requirements. Only the 
in-clinic visits and the visits during the home treatment phase have been assigned a 
specific visit number: 
1. Inclusion phase – Screening & consent (Visit 1).  
2. In-clinic treatment phase (Visits 2–4; approximately 2 weeks). 
3. Randomization phase – No visit. 
4. Transition to home treatment phase – Visit T1 to T7 (2 to 7 visits; approximately 1 
week). 
5. Home treatment phase – Visit 5 and 6 (8 weeks; 4 weeks in the control arm and 4 
weeks in the treatment arm). 
CRITERIA FOR 
EVALUATION / 
STATISTICAL METHODS 
Primary endpoint 
• 
The UF volume of the control CAPD dwell and the Carry Life® UF treatment will 
be measured per protocol at each efficacy evaluation treatment (two days per 
treatment arm) during the home treatment phase. 
• 
Each subject is expected to have two efficacy evaluations per treatment arm. 
Subjects with one or more evaluations in each arm will be included in the 
primary endpoint analysis. Both the PP and ITT populations will be analyzed. 
Excluded subjects will be tabulated with narratives as to why they missed 
efficacy evaluations. 
• 
A UF volume during the Carry Life® UF treatment exceeding with ≥ 250 ml the UF 
volume obtained with the 2.27% glucose CAPD dwell is considered clinically 
relevant.  
 
Secondary endpoints   
• 
AE and SAE rates: Based on all safety data gathered during the home treatment 
phase of the study for the Intent-To-Treat (ITT) dataset, AE and SAE occurrences 
will be collected, summarized, and presented.  
• 
Peritoneal sodium removal:  
o Based on data gathered from the efficacy evaluation treatments during 
the home treatment phase of the study, peritoneal sodium removal will 
be calculated and summarized.  
o Each subject is expected to have two efficacy evaluations per treatment 
arm. Subjects with one or more evaluations in each arm will be included 
in the endpoint analysis. Excluded subjects will be tabulated with 
narratives as to why they missed efficacy evaluations.  
o A statistically significant increase in sodium removal between the Carry 
Life UF treatment and the 2.27% glucose CAPD dwell will be determined 
by a t-test.  

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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• 
Glucose UF efficiency:  
o Based on data gathered from the efficacy evaluation treatments during 
the home treatment phase of the study, glucose UF efficiency will be 
calculated and summarized.  
o Each subject is expected to have two efficacy evaluations per treatment 
arm. Subjects with one or more evaluations in each arm will be included 
in the endpoint analysis. Excluded subjects will be tabulated with 
narratives as to why they missed efficacy evaluations.  
o A statistically significant increase in glucose UF efficiency between the 
Carry Life UF treatment and the 2.27% glucose CAPD dwell will be 
determined by a t-test. 
• 
Peak dialysate glucose concentration:  
o During the in-clinic treatment phase the peak peritoneal glucose 
concentration during each glucose dose of the Carry Life® UF treatments 
will be determined.  
o Each subject is expected to have one in-clinic Carry Life UF treatment per 
glucose dose with hourly dialysate sampling points during the treatment.  
Subjects with dialysate glucose data from one or more sampling points 
will be included in the endpoint analysis. Excluded subjects will be 
tabulated with narratives as to why they missed the endpoint evaluation. 
A t-test will be used to determine that the peak dialysate glucose concentration during 
the Carry Life® UF treatment is lower than 2.27%. 
A subject may be excluded for one or more secondary endpoints, that is, exclusions are 
made independently for each endpoint.  
SAMPLE SIZE 
JUSTICATION  
The sample size is calculated using the UF volume data from a previous pilot study 
(Tmed-007). The difference between the Carry Life® UF and the control 2.27% CAPD 
dwell had a mean value of 574 ml and a standard deviation of 236 ml. The aim is to 
demonstrate superiority over the control by a margin delta (δ), of 250 ml. 
 
Assuming a standard deviation of 236 ml, an expected difference of 574 ml and a 
superiority margin of 250 ml requires a sample size of 3 to obtain 80% power for the 
superiority test ( = 0.025) using a one sample superiority (one-sided) t-test sample size 
calculation.   
 
We also consider a more extreme case where we assume a standard deviation of 1.4 
times the previous standard deviation, or 330 ml. Further, we lower our assumed mean 
difference to 400 ml (about 0.7s below the previous observed value). With these 
assumptions (standard deviation of 330 ml, an expected difference of 400 ml, and a 
superiority margin of 250 ml) we require a sample size of 19 to obtain 80% power for the 
superiority test ( = 0.025).  
 
The study size of 25 was selected based on the conservative sample size with additional 
subjects to account for possible dropouts. 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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Figure 2. Clinical investigation visits 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Visit 1 
Screening and inclusion visit 
Visit 2 
2.27% glucose PET,  
4-hour dwell  
Inclusion phase 
In-clinic treatment phase 
Transition to home phase 
Immediately preceding the Carry Life® UF 
arm of the home phase 
Visit 3 
Carry Life® UF, 11 g/h glucose 
5-hour treatment 
Visit 4 
Carry Life® UF, 15 g/h glucose  
5-hour treatment 
2-7 training visits (T1-T7) 
Carry Life® UF, 11 g/h or 15 g/h glucose  
2-hour training sessions 
Randomization phase 
Home treatment phase 
Treatment at home four weeks per arm; 
starting either with the control arm or with 
the Carry Life® UF arm 
Visit 5 and 6 
End of arm visits 
Study follow up  
Phone call or physical visit, 7 days after end-of-
study  

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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Table 1. Schedule of activities 
Visit 
V1 
Screening 
& 
Inclusion 
V2-V4  
(In-clinic 
treatments) 
Randomization 
T1-T7 
(Device 
training) 
Home 
treatment 
(two 
sampling 
days) 
V5  
T1-T7 
(Device 
training) 
Home 
treatment 
(two 
sampling 
days) 
V6/End of 
study 
Time 
point/duration 
Group 
A, B 
-14–0 
Days 
Week 1–2  
Week 2 
 
Week 3–6 
Week 
6 
Week 7 
Week 8–11 
Week 11/After 
premature 
ending of study 
Group 
C, D 
Week 3 
Week 4–7 
Week 
7 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
Inclusion and exclusion 
criteria 
X 
 
 
 
 
 
 
 
 
Demographicsa 
X 
 
 
 
 
 
 
 
 
Medical historyb 
X 
 
 
 
 
 
 
 
 
Concomitant medicationsc 
X 
X 
 
X 
X 
X 
X 
X 
X 
Baseline PD prescriptiond 
X 
 
 
 
 
 
 
 
 
Fluid restrictione 
X 
X 
 
X 
X 
X 
X 
X 
X 
Randomization 
 
 
X 
 
 
 
 
 
 
Vital signs & body weightf 
 
X 
 
 
X 
X 
 
X 
X 
Food intake and fluid 
intake & urinary outputg 
 
X 
 
 
 
 
 
 
 
Blood samplesh 
 
X 
 
 
 
X 
 
 
X 
Dialysate samplesi 
 
X 
 
 
X 
 
 
X 
 
PD bags usedj 
 
X 
 
 
X 
 
 
X 
 
Fill and drain volumesk 
 
X 
 
 
X 
 
 
X 
 
24-hour urine samplel 
 
X (V2 only) 
 
 
 
X 
 
 
X 
24-hour UF volumem 
 
 
 
 
X 
 
 
X 
 
Carry Life® UF safety 
assessmentn 
 
X 
 
 
 
 
 
 
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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Visit 
V1 
Screening 
& 
Inclusion 
V2-V4  
(In-clinic 
treatments) 
Randomization 
T1-T7 
(Device 
training) 
Home 
treatment 
(two 
sampling 
days) 
V5  
T1-T7 
(Device 
training) 
Home 
treatment 
(two 
sampling 
days) 
V6/End of 
study 
Transition to home 
evaluation  
 
X 
 
 
 
 
 
 
 
Device competency 
assessment 
 
 
 
X 
 
 
X 
 
 
Subject clinical evaluationo 
 
 
 
 
X 
 
 
X 
 
AEs and SAEsp 
 
X 
 
X 
X 
X 
X 
X 
X 
Device malfunctionsq 
  
X 
 
X 
X 
 
X 
X 
 
 
Footnotes: 
a. Year of birth, age, gender, ethnicity, height, body weight.  
b. Cause of end-stage kidney disease (ESKD), year of diagnosis of kidney disease, start of peritoneal dialysis (PD), start of ESKD therapy other than PD (if applicable) 
and comorbidities. 
c. 
Concomitant medications will be recorded. Any changes in prescription of medications will be recorded throughout the study, for diuretics and diabetes 
medication, the reason for change of prescription will be documented.  
d. Baseline PD prescription: volumes and glucose concentration for the day dwells, volume for the icodextrin, and volume and glucose concentration for 
glucose-based night dwell, as applicable). 
e. Any changes in fluid restriction will be recorded throughout the study. The reason for change in fluid restriction will be documented.  
f. 
In-clinic phase: Body weight, systolic and diastolic blood pressure and heart rate will be measured before and after treatment. 
Home phase: The subjects will record body weight, systolic and diastolic blood pressure, and heart rate daily.  
g. 
In-clinic phase: Food intake and fluid intake as well as urinary output during the in-clinic visits will be documented.  
h. In-clinic phase and home phase: The following blood chemistry parameters will be analyzed at visit 2 (baseline), visit 5, and visit 6: Sodium, potassium, magnesium, 
calcium (ionized), phosphate, albumin, creatinine, urea and parathyroid hormone. Creatinine and urea at visit 2, 5, and 6 will be used for calculation of residual 
renal function. Plasma creatinine before the PET will be used for calculation of D/P creatinine.  
In addition, blood glucose will be measured before the treatment, at 30 min, at 1 h and then hourly until the end of treatment for the three in-clinic treatments.  
i. 
In clinic phase: PET: Dialysate samples will be collected at 0, 1, 2 and 4 hours for analysis of dialysate glucose and creatinine for determination of peritoneal 
membrane transfer type (4 h D/P creatinine and D/D0 glucose ratios). Sodium concentration at each time point will also be analyzed. After the completion of 
infusion (T0) and at the 1- and 2-hour dwell time, 200 mL of dialysate will be drained. A 10 mL sample will be taken, and the remaining 190 will be infused back into 
the peritoneal cavity.  

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
 Page 10 | 97 
 
Carry Life® UF treatments: 10 ml dialysate samples at 0, 1, 2, 3, 4 and 5 hours will be analyzed for dialysate glucose and sodium for evaluation of dialysate glucose 
and sodium concentrations during treatment. All PD fluid automatically drained (and any additional drains) during the Carry Life® UF treatment will be pooled. The 
pooled PD fluid, plus the final peritoneal drain will be analyzed for dialysate glucose, sodium, potassium, calcium, phosphate, albumin, creatinine, and urea for 
calculation of glucose ultrafiltration (UF) efficiency, glucose absorption and peritoneal removal of the listed substances. 
Home phase efficacy evaluation days, during week 2 and week 4 or each arm: Drained dialysate from the control and Carry Life® UF efficacy evaluation 
treatments (Carry Life® UF drain bag + final peritoneal drain) will be collected by a research assistant for analysis of dialysate glucose, sodium, potassium, calcium, 
phosphate, albumin, creatinine, and urea, for calculation of glucose absorption, glucose UF efficiency, and peritoneal removal of the listed substances.  
j. 
In-clinic phase: The volume and glucose concentration of PD bags used for the PET and Carry Life® UF treatments will be recorded. 
Home treatment phase: The subjects will record information of all PD bags used (volume and glucose concentration for glucose-based solutions and volume for   
icodextrin). 
k. 
In-clinic phase: The PD bag and glucose bag will be weighed by a clinical professional before the treatment and the drain bag(s) will be weighed after the 
treatments for calculations of fill volume, drained volume and UF volume. 
Home treatment phase: Subject will record fill and drain weights of all dwells every day during the home phase. 
Home treatment phase efficacy evaluation days: A research assistant will weigh the solution bags (PD bag and glucose bag), and the drain bags for calculations of 
fill volume, drained volume and UF volume.   
l. 
24-hour urine volume and urine concentration of creatinine and urea will be collected for calculation of residual renal function.  
m. The patient will weigh the PD bag, glucose bag and drain bag(s) for each CAPD dwell/Carry Life® UF treatment during the home phase of the study for evaluation of 
weekly UF volume. 
n. To assess the Carry Life® UF safety at the different glucose doses, each in-clinic Carry Life® UF treatment will be evaluated for the following:  
     
   1) a systolic blood pressure of < 100 mmHg. 
    
   2) an UF rate higher than 20 ml/kg body weight/treatment.  
o. Subjects will be contacted weekly for evaluation of body weight, blood pressure, volume status and clinical symptoms.  
p. A nurse adequately trained in AE reporting will specifically ask the subject for occurrences of AEs and SAEs during a weekly call.  
q. The nurse will specifically ask the subject for occurrences of Carry Life® UF device malfunctions weekly.

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
 Page 11 | 97 
 
TABLE OF CONTENTS 
1 
Synopsis ................................................................................................................................ 2 
2 
Identification and Description of the Investigational Device .................................................. 19 
2.1 Summary description of the investigational device and its intended purpose ..................... 19 
2.2 Manufacturer of the investigational device .......................................................................... 20 
2.3 Device regulatory status and classification ........................................................................... 20 
2.4 Identification and traceability of the devices ........................................................................ 20 
2.5 Intended Purpose .................................................................................................................. 21 
2.6 General Description of the Carry Life® UF system ................................................................ 21 
2.6.1 Carry Life® UF Cycler ...................................................................................................... 22 
2.6.2 Carry Life® UF Line set ................................................................................................... 22 
2.6.3 Carry Life UF Carrying bag ............................................................................................. 26 
2.6.4 Peritoneal dialysis solution ............................................................................................ 26 
2.6.5 Glucose solution ............................................................................................................ 26 
2.7 Summary of required experience/training ............................................................................ 26 
2.8 Description of specific medical procedures involved in the use of the investigational device
 
26 
3 
Rationale for the design of the clinical investigation ............................................................. 27 
3.1 Background ............................................................................................................................ 27 
3.2 Overview of fluid overload in patients using PD therapies ................................................... 27 
3.3 Current strategies to manage fluid overload ........................................................................ 28 
3.4 Peritoneal ultrafiltration and survival ................................................................................... 29 
3.5 Peritoneal glucose load ......................................................................................................... 29 
3.6 Peritoneal sodium removal ................................................................................................... 30 
3.7 Exploratory studies with maintained intraperitoneal glucose concentration ...................... 30 
3.8 Clinical experience with the Carry Life® UF device ............................................................... 31 
3.9 Rationale for the clinical investigation .................................................................................. 32 
4 
The Risks and Benefits of the Investigational Device and clinical investigation ....................... 35 
4.1 Anticipated clinical benefits .................................................................................................. 35 
4.2 Anticipated benefits for participants..................................................................................... 35 
4.3 Anticipated adverse device effects ....................................................................................... 36 
4.4 Residual risks associated with the device.............................................................................. 40 
4.5 Risks associated with participation in the clinical investigation and mitigation ................... 40 
4.6 Possible interactions with concomitant medical treatments ................................................ 41 
4.7 Benefit to risk rationale ......................................................................................................... 41 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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5 
Objectives of the clinical investigation.................................................................................. 42 
5.1 Objectives .............................................................................................................................. 42 
5.1.1 Primary objective ........................................................................................................... 42 
5.1.2 Secondary objectives ..................................................................................................... 42 
5.1.3 Exploratory objectives ................................................................................................... 42 
5.2 Hypotheses to be accepted or rejected by statistical data from the clinical investigation .. 42 
5.3 Claims of performance of the device .................................................................................... 43 
5.4 Risks and anticipated adverse device effects to be assessed ................................................ 44 
6 
Design of the clinical investigation ....................................................................................... 45 
6.1 General .................................................................................................................................. 45 
6.2 Description of clinical investigation phases........................................................................... 46 
6.2.1 Inclusion phase (Visit 1) ................................................................................................. 46 
6.2.2 In-clinic treatment phase for dose determination and safety evaluation .................... 47 
6.2.3 Randomization phase .................................................................................................... 49 
6.2.4 Transition to home phase .............................................................................................. 49 
6.2.5 Home treatment phase for efficacy and safety evaluation ........................................... 50 
6.2.6 Description of measures to minimize or avoid bias ...................................................... 52 
6.2.7 Endpoints ....................................................................................................................... 53 
6.2.8 Methods and timing for assessing, recording, and analyzing of variables .................... 54 
6.2.9 Equipment for assessing the clinical investigation variables ........................................ 57 
6.2.10 Investigational device and comparator ......................................................................... 58 
6.2.11 Other materials/products required for the clinical investigation ................................. 58 
6.3 Subjects ................................................................................................................................. 60 
6.3.1 Subject selection ............................................................................................................ 60 
6.3.2 Criteria and procedures for subject withdrawal or discontinuation ............................. 61 
6.3.3 Procedures for replacing subject ................................................................................... 62 
6.4 Procedures ............................................................................................................................. 62 
6.4.1 Clinical investigation related procedures ...................................................................... 62 
6.4.2 Activities performed by sponsor representatives ......................................................... 64 
6.4.3 Foreseeable factors that may compromise the outcome of the clinical investigation or 
the interpretation of results .................................................................................................... 64 
6.5 Monitoring ............................................................................................................................. 65 
7 
Statistical considerations ..................................................................................................... 67 
7.1.1 Sample size .................................................................................................................... 67 
7.1.2 Intent to treat population ............................................................................................. 68 
7.1.3 Safety population .......................................................................................................... 68 
7.1.4 Per protocol population ....................................................Error! Bookmark not defined. 
7.1.5 Per protocol treatments ................................................................................................ 68 
7.1.6 Randomization method ................................................................................................. 69 
7.1.7 Statistical analysis of primary endpoint ........................................................................ 69 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
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Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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7.1.8 Statistical analysis of secondary endpoint .................................................................... 70 
7.1.9 Statistical analysis of exploratory endpoints ................................................................. 71 
7.1.10 Description and interference ......................................................................................... 71 
7.1.11 Missing values ................................................................................................................ 71 
7.1.12 Additional summaries .................................................................................................... 71 
7.1.13 Listings ........................................................................................................................... 71 
8 
Data management ............................................................................................................... 72 
8.1 Procedures used for data review .......................................................................................... 72 
8.2 Procedures for verification, validation and securing of electronic data systems ................. 73 
8.3 Data retention and specified period ..................................................................................... 73 
9 
Amendments to the CIP ....................................................................................................... 74 
10 Deviations from clinical investigation plan ........................................................................... 75 
11 Device accountability ........................................................................................................... 76 
12 Statements of compliance .................................................................................................... 77 
12.1 Ethical principles .................................................................................................................... 77 
12.2 International standards ......................................................................................................... 77 
12.3 Start of clinical investigation ................................................................................................. 77 
12.4 Additional requirement by EU or regulatory authority ......................................................... 77 
12.5 Insurance ............................................................................................................................... 77 
12.6 Financing ................................................................................................................................ 78 
13 Informed consent process .................................................................................................... 79 
13.1 Patient confidentiality ........................................................................................................... 79 
14 Safety .................................................................................................................................. 81 
14.1 Patient Safety Assessments during the Carry Life® UF study sessions .................................. 81 
14.1.1 Excessive UF volumes .................................................................................................... 81 
14.1.2 Clinical evaluation .......................................................................................................... 81 
14.1.3 Increased IP volumes ..................................................................................................... 81 
14.1.4 Abnormalities in the plasma glucose and electrolyte ................................................... 81 
14.2 Safety Definitions .................................................................................................................. 81 
14.2.1 Adverse Event (AE) ........................................................................................................ 82 
14.2.2 Serious Adverse Events (SAE) ........................................................................................ 82 
14.2.3 Device deficiencies ........................................................................................................ 82 
14.2.4 Device deficiency with SADE potential .......................................................................... 82 
14.2.5 Adverse device effect (ADE) .......................................................................................... 83 

 
 
 
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Study No.: Tmed-010 
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14.2.6 Serious Adverse Device Effect (SADE) ........................................................................... 83 
14.2.7 Unanticipated Serious Adverse Device Effect (USADE) ................................................. 83 
14.3 Reporting of safety events .................................................................................................... 83 
14.4 Identification, recording and reporting adverse events ........................................................ 83 
14.4.1 Recording adverse events ............................................................................................. 83 
14.4.2 Safety monitoring .......................................................................................................... 84 
14.4.3 Isolation of the investigational device ........................................................................... 85 
14.5 Investigators reporting responsibilities ................................................................................. 86 
14.6 Sponsors reporting responsibilities ....................................................................................... 86 
14.6.1 Reportable events to Competent Authorities (CAs) and Ethic committees (ECs) ......... 87 
14.7 Assessments of Adverse Events ............................................................................................ 87 
14.7.1 Severity assessment ...................................................................................................... 87 
14.7.2 Causality assessments ................................................................................................... 88 
15 Vulnerable population ......................................................................................................... 90 
16 Suspension or premature termination of the clinical investigation ........................................ 91 
16.1 End of the clinical investigation ............................................................................................. 91 
16.2 Suspension of the clinical investigation ................................................................................ 91 
16.3 Procedure for resuming the clinical investigation after temporary suspension ................... 92 
17 Publication policy ................................................................................................................ 93 
18 Bibliography ........................................................................................................................ 94 
19 Signed agreement of the clinical investigation plan .............................................................. 96 
20 Attachments ........................................................................................................................ 97 
20.1 Attachment A. Principal investigator, coordinating investigator and investigation site(s) ... 97 
20.2 Attachment B. Checklist for assessment of Carry Life® UF user competency ....................... 97 
20.3 Attachment C.  Setting the Carry Life® UF glucose dose ....................................................... 97 
20.4 Attachment D. The PET procedure (Visit 2) ........................................................................... 97 
20.5 Attachment E. Weighing and sampling procedure, visits 3 and 4 ......................................... 97 
20.6 Attachment F. Weighing and sampling procedure during the efficacy evaluation treatments 
of the home Phase ........................................................................................................................ 97 
 
 
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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LIST OF TABLES 
 
Table 1. Schedule of activities .................................................................................................................. 8 
Table 2. Device and accessory identification and traceability ............................................................... 21 
Table 3. Main components in the Carry Life® UF Line set:  Supplier of component, raw materials, raw 
material supplier and tests performed by material supplier ................................................................. 24 
Table 4. The approximal absorption of glucose in high/high average transports with different glucose 
concentrations during a 4-hour dwell .................................................................................................... 28 
Table 5. Patient/caregiver activities performed at home to use the Carry Life® UF System ................. 34 
Table 6. The anticipated adverse events with the Carry Life® UF compared to standard PD treatment 
and their mitigations .............................................................................................................................. 36 
Table 7. The tests methods, recording and analysis of variables ........................................................... 54 
Table 8. Carry Life® UF treatments during the clinical investigation ..................................................... 58 
Table 9. Products used in the clinical investigation ............................................................................... 58 
Table 10. The composition of different Baxter low strength glucose PD solutions ............................... 59 
Table 11. Definition of intention to treat and per protocol populations ............................................... 68 
Table 12. Reporting information for SAE and SADE ............................................................................... 85 
Table 13. Assessment of severity ........................................................................................................... 87 
Table 14. Assessment of causality .......................................................................................................... 88 
 
 
LIST OF FIGURES 
Figure 1. Study flow chart ......................................................................................................................... 4 
Figure 2. Clinical investigation visits ......................................................................................................... 7 
Figure 3. The Carry Life® UF system ........................................................................................................ 20 
Figure 4. The Carry Life® UF line set ....................................................................................................... 23 
 
 
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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LIST OF ABBREVIATIONS AND DEFINITIONS 
ADE 
Adverse device effect 
AE  
Adverse event 
APD  
Automated peritoneal dialysis. APD uses a cycler and is divided into APD with a day dwell 
and “day dry”. APD is also known as nocturnal intermittent peritoneal dialysis (NIPD) as it is 
often performed at night 
BNP 
B-type natriuretic peptide. BNP is produced as a response to increased mechanical load and 
wall stretch by the ventricles of the heart. It protects the heart from adverse consequences 
of overload by increasing natriuresis and diuresis, relaxing vascular smooth muscle, 
inhibiting the renin-angiotensin-aldosterone system, and by counteracting cardiac 
hypertrophy and fibrosis 
Bpm 
Beats per minute 
CA 
Competent Authority  
CAPD  
Continuous ambulatory peritoneal dialysis. Performed manually at 4 hourly intervals and 
dialysate is constantly present in the peritoneal cavity 
CI 
Confidence interval 
CFPD 
Continuous flow peritoneal dialysis 
CKD  
Chronic kidney disease  
eCRF  
electronic Case Report Form 
D/P sodium or 
D/P creatinine 
The D/P sodium is the rate at which sodium or creatinine equilibrates between the dialysate 
and plasma 
DD 
Device deficiency 
Dialysate  
Is the term used for PD solutions once dialysis has occurred, although the term “dialysate” is 
commonly used for fresh as well as for used or “spent” solution. In this document dialysate 
and intraperitoneal fluid are used interchangeably 
Dry weight  
Dry weight for PD is the weight that gives a well-tolerated normotensive, edema-free status 
Dwells in PD 
The length of time that the PD solution remains in the peritoneal cavity 
EDC 
Electronic data capture 
Edema 
Is swelling caused by excess fluid in the body's tissues and predominant affects the hands, 
arms, feet, ankles, and legs. If untreated it can result in shortness of breath called 
pulmonary edema which is serious and can be life threatening  
Electrolyte 
In this document electrolytes refers to Sodium (Na+), Potassium (K+), Magnesium (Mg2+), 
Calcium (Ca2+), Phosphate (PO43–), bicarbonate (HCO3-), lactate, base excess (BE) 
ePROM 
Electronic patient-reported outcome measure 
ETO  
Ethylene oxide  
GDPR 
General data protection regulation 
HD 
Hemodialysis 
HR 
Heart rate 
Hemodynamic 
instability 
Is the term most commonly associated with an abnormal or unstable blood pressure, 
especially hypotension 
Hypotension 
Is abnormally low blood pressure 
IB 
Investigator’s brochure 
ICF 
Informed consent form 
ICH 
International Conference on Harmonization 
IEC 
Independent ethics committee  
IFU 
Instructions for use 
IP 
Intraperitoneal fluid. Is the term used for the PD solution in the peritoneal cavity 
ISF 
Investigator site file 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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ISO 
International Organization for Standardization  
ITT 
Intent-to-treat 
MDR 
Medical device regulation 
NCA 
National Competent Authority 
Net fluid loss 
The sum of the total fluid intake minus the total fluid output 
NIPD 
Nocturnal intermittent peritoneal dialysis. See APD 
NTPD 
Nightly tidal peritoneal dialysis. Is a technique in which, after an initial fill of the peritoneal 
cavity, only a portion of dialysate is rapidly cycled 
Osmotic 
gradient 
Osmotic gradient is the difference in concentration between two solutions on either side of 
a semipermeable membrane 
PD 
Peritoneal dialysis 
PET 
Peritoneal Equilibrium Test. A semiquantitative assessment of peritoneal membrane 
transport in patients on peritoneal dialysis 
POM 
Polyoxymethylene 
PP 
Per protocol 
PTH 
Parathyroid hormone 
PVC 
Polyvinyl chloride 
Reflection 
coefficient 
Is the term used to reflect the osmotic agent’s effectiveness to diffuse out of the dialysis 
solution into the peritoneal capillaries and the range is between 0 and 1 
RRF 
Residual renal function  
SADE 
Serious adverse device effect 
SAE 
Serious adverse event  
SCPD 
Steady concentration peritoneal dialysis 
SD 
Standard deviation  
Sieving effect 
Each solute has a sieving coefficient that depends on the molecular weight and charge. 
Higher sieving coefficients indicate lower permeability of the solute.  
Study session  
The term study sessions refer to both the Baseline and Carry Life® UF sessions 
TMF 
Trial master file  
Tonicity  
Tonicity is a measure of the effective osmotic pressure gradient of a solution 
UF 
Ultrafiltration is the removal of fluid during PD primarily by osmotic pressure gradient 
USADE 
Unanticipated serious adverse device effect 
  
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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REVISION HISTORY 
This section records all changes made to controlled versions of the Clinical Investigation Plan (CIP).  
 
Revision 
Date 
Revision Author, Organization 
Comments/Changes 
V1.0 
Mar 01 2023 
Original Version  
N/A 
V2.0 
May 09 2023 
Charlotte de Leon, Triomed 
Update base on MHRA pre- 
clinical assessment May 04 
2023. 
Minor corrections. 
V3.0 
May 17 2023 
Charlotte de Leon, Triomed 
Update based on MHRA pre-
clinic assessment May 15 
2023, Statistical analysis 
clarifications.  
V4.0 
May 25 2023 
Charlotte de Leon, Triomed 
Update based on MHRA pre-
clinic assessment May 23 
2023. Statistical analysis 
update, change from alpha 
0.05 to 0.025. 
V5.0 
Aug 1 2023 
Charlotte de Leon, Triomed 
Update to clarify that 
icodextrin overnight PD-dwell 
before visit 2 (PET) should be 
replaced by a 2.27% glucose 
PD dwell. This is in alignment 
with other documents (CIP 
attachment D and the patient 
information sheet). 
V6.0 
Feb 08 2024 
Charlotte de Leon, Triomed 
Adding a run-in period to allow 
a change of PD prescription to 
meet inclusion criteria. 
Increasing the number of sites 
to up to 12.  
 
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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2 IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE  
2.1 SUMMARY DESCRIPTION OF THE INVESTIGATIONAL DEVICE AND ITS INTENDED PURPOSE 
The intended use of the Carry Life® UF system is for peritoneal dialyses (PD) and ultrafiltration (UF). 
The therapeutic concept of the Carry Life® UF system is to maintain a stable intraperitoneal (IP) 
glucose concentration and thereby achieving a stable peritoneal UF. The Carry Life® UF system is 
indicated for PD and UF in adult patients with end-stage kidney disease (ESKD). Treatment with the 
Carry Life® UF system is prescribed by the treating physician and intended for use in dialysis clinics or 
in the home environment. 
 
The Carry Life® UF system consists of the following parts: 
• 
Carry Life® UF Cycler.  
• 
Carry Life® UF Line set. 
• 
Carry Life® UF Carrying bag. 
• 
Carry Life® UF Storage bag. 
• 
Battery and battery charger. 
 
Treatment with the Carry Life® UF system also requires the following products: 
• 
A standard PD catheter.  
• 
A standard Baxter MiniCap extended life PD transfer set with twist clamp for access to the 
intraperitoneal catheter. 
• 
A PD belt (Frank Stubbs). 
• 
A 13.6 mg/ml glucose (1.36 %), 1.5 or 2L Baxter Peritoneal Dialysis solution. 
• 
A 500 mg/ml, 500 ml Glucose Fresenius Kabi solution for infusion. 
 
In this clinical investigation, subjects will already have a standard PD catheter and an extension set, 
and use the PD bags provided in their standard PD prescription. For participation in this clinical 
investigation, the Sponsor, or their designee, will provide the PD belt, and the glucose PD solution. 
 
The Carry Life® UF Cycler with line set and glucose bag attached is illustrated in Figure 3.  

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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Figure 3. The Carry Life® UF system 
 
Refer to the Investigator’s Brochure (IB) and Instructions for Use (IFU) for further details. 
2.2 MANUFACTURER OF THE INVESTIGATIONAL DEVICE 
Triomed AB 
Address: Scheelevägen 20, 223 63 Lund, Sweden 
Contact telephone: +46 46 460 20 00 
2.3 DEVICE REGULATORY STATUS AND CLASSIFICATION 
The Carry Life® UF system is not CE-marked and is considered an investigational device in this clinical 
investigation. 
 
• 
Carry Life UF® Cycler: Class IIb per MDR 2017/745, Rule 12. 
• 
Carry Life UF® Line set: Class IIa per MDR 2017/745, Rule 2. 
• 
Carry Life® UF Carrying bag: Accessory, Class I per MDR 2017/745, Rule 1. 
• 
Carry Life® UF Storage bag: N/A. 
• 
Battery and battery charger: N/A. 
2.4 IDENTIFICATION AND TRACEABILITY OF THE DEVICES 
Devices will be delivered to the study subjects by the Investigator, or its delegate. Any special 
procedures, such as calibration and maintenance of the devices, will be conducted per the device 
label. If a device breaks, malfunctions, or is lost, a replacement device will be provided to the site by 
the Sponsor, or its delegate, for the study subject to continue participation in the clinical 
investigation. 
 
Glucose pump 
Hand control 
Glucose bag 
Line set 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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Table 2. Device and accessory identification and traceability 
Device/Accessories 
Ref.  
Traceability recorded in CRF 
Cycler delivery kit* 
321100 
Lot number 
Carry Life® UF Cycler  
321101 
(SW version 100C11_1.2.2, 
100C12_1.2.1) 
Serial number 
Battery  
RCC2054 
Serial number 
Battery charger and adaptor 
110115-01 
Serial number 
Carry Life® UF Carrying bag 
321121 
Lot number 
Carry Life® UF Storage bag 
321222 
Lot number 
Carry Life® UF - B Line set  
321106 
Lot number 
PD belt (Frank Stubbs) 
XS, S, M, L or XL 
Lot number 
* All components of the delivery kit will be traceable from the lot number of the delivery kit. 
2.5 INTENDED PURPOSE 
The Carry Life® UF system is indicated for PD and UF in adult patients with ESKD treated with 
continuous ambulatory peritoneal dialysis (CAPD) with the objective of providing PD and UF. 
 
In this clinical investigation the device will be used by clinical professionals in a clinical setting in the 
hospital environment and by the patient or caregiver in the home environment. 
2.6 GENERAL DESCRIPTION OF THE CARRY LIFE® UF SYSTEM  
In CAPD, the glucose concentration of the PD fluid is reduced as the glucose is absorbed across the 
peritoneal membrane, resulting in a reduced UF rate or even fluid re-absorption by the end of the 
dwell. 
 
The Carry Life® UF is a novel system that performs peritoneal dialysis with the method of steady 
concentration PD. Throughout the 5-hour Carry Life® UF treatment glucose is administered to the 
dialysate in the patient’s peritoneal cavity to compensate for glucose absorption. By doing this the 
glucose concentration in the dialysate is sustained and the peritoneal UF is maintained throughout 
the treatment. Treatment with Carry Life® UF will result in an increased UF volume compared to a 
2.27% CAPD dwell. Furthermore, removal of low molecular weight solutes may occur during the 
treatment as these will follow with the fluid, i.e., with convective solute transport. 
 
The Carry Life® UF treatment starts with an initial fill of the peritoneal cavity with a 1.5 L or 2 L 1.36% 
glucose PD solution. Following dressing of the Carry Life® UF cycler with the line set and connecting 
the 50% glucose solution in accordance with the instructions in the IFU, the device is connected to 
the patient and priming of the line set is performed using a small amount of the IP fluid from the 
initial fill which is emptied into the drainage bag.  
 
During the treatment a small volume of IP fluid is transferred back and forth between the peritoneal 
cavity and the device. Glucose is mixed and diluted in the IP fluid, which is transferred into a reservoir 
bag (pressure chamber bag) inside the pressure chamber of the device The addition of glucose occurs 
in 13.5-minute cycles during which approximately 70 ml of IP fluid is transferred at 30 second 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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intervals to and from the device.  When the glucose volume to be dosed each cycle has been 
administered, the glucose pump remains stopped until the next cycle begins. The device 
automatically drains approximately 180 ml of dialysate every hour into a drainage bag resulting in 
approximately 900 ml UF being drained during the 5-hour treatment.  
 
The device can administer two different glucose doses: 11 g and 15 g glucose per hour. 
2.6.1 
Carry Life® UF Cycler 
The cycler controls the intermittent transfer of the IP fluid into and out of the patient as well as 
addition of the glucose solution. This is done by means of a pressure chamber, a peristaltic pump, and 
valves that control the fluid direction. The pressure chamber is the driving force for the fluid 
movement, into and out from the pressure chamber bag. The cycler is operated by a hand control 
and powered by a standard rechargeable battery, which is delivered with the device. The chassis of 
the cycler is made of plastic (POM) and lids and glucose pump is made of anodized aluminum. 
2.6.2 
Carry Life® UF Line set 
The line set connects to the patient’s PD catheter extension set and the IP fluid is channeled to the 
pressure chamber bag in a closed circuit and back to the patient, or to the drain bag. The disposable 
line set is made of polyvinyl chloride (PVC) and is ethylene oxide (ETO) sterilized. The line set is not 
made of latex and components in the fluid path are not made with phthalates. The line set is 
delivered sterile and individually packed in a sterile pouch labelled “CAUTION! Exclusively for Clinical 
Investigation” / “FÖRSIKTIGHET! Enbart för Klinisk Prövning”. 
 
The line set contains five tubes, which are connected to a line organizer: 
• 
Patient line. 
• 
Glucose line. 
• 
Drain line. 
• 
Pressure bag line. 
• 
Pressure sensor line. 
 
All lines except the pressure sensor line have a protective cap which is removed before connection. 
The pressure sensor line ends with a transducer protector which has a sterile filter incorporated.  
 
The flow path of the line set is in contact with the IP fluid and the material in the flow path is thereby 
in indirect contact with the peritoneal cavity/membrane of the patient during treatment. All materials 
in the line set with fluid contact are medical grade and the line set has undergone in vitro and in vivo 
testing and a biological evaluation according to EN ISO 10993:2018. Figure 4 shows the Carry Life® UF 
line set with its components.  
 
 
 
 
 
 
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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Figure 4. The Carry Life® UF line set 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 3 below shows the materials of the different components with human body fluid contact. Refer 
to the IB for further details. 
 
 
 
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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Table 3. Main components in the Carry Life® UF Line set:  Supplier of component, raw materials, raw material supplier and tests performed by 
material supplier 
Component  
Supplier 
Raw material description / supplier 
Biocompatibility tests performed by raw material supplier 
Pressure bag 
 
 
Qosina, standard component 
 
 
 
 
PVC EH-222 from Renolit 
 
Material fulfills USP class VI test requirements. 
Material fulfills the following ISO 10993:2018 test requirements: 
• 
Cytotoxicity. 
• 
Sensitization. 
• 
Intracutaneous irritation. 
• 
Acute systemic toxicity. 
• 
Implantation. 
Spike  
 
 
 
Qosina, standard component 
 
Lustran ABS M205FC-011220 from Elix 
Polymers 
 
Supplier’s equivalent material fulfills USP class VI test requirements, 
and the following ISO 10993:2018 test requirements: 
• 
Pyrogenicity. 
• 
Systemic toxicity. 
• 
Hemocompatibility, hemolysis. 
• 
Implantation. 
• 
Cytotoxicity. 
• 
Sensitization. 
• 
Intracutaneous irritation. 
• 
Mutagenicity (AMES). 
Transducer 
protector (26) 
320340D 
 
LUC & BEL, standard 
component (0.2 µm 
hydrophobic membrane 
filter), 
Part no. A00820610W 
 
Housing: PVC AM22 W17, AM22 
W1645 from TPV Compound S.R.L. 
 
Membrane: MMT-323 Gore (PTFE on 
polyester support) from W.L. Gore. 
The membrane has undergone 
bacterial filtration efficiency testing at 
an increased challenge level by an 
independent accredited laboratory 
(Nelson laboratories, Protocol No. 
All materials fulfill USP class VI test and ISO 10993:2018 cytotoxicity 
test requirements. 
 
PVC AM22 materials additionally fulfill the following ISO 10993:2018 
test requirements: 
• 
Sensitization. 
• 
Intracutaneous irritation. 
• 
Acute systemic toxicity. 
• 
Hemolysis. 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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Component  
Supplier 
Raw material description / supplier 
Biocompatibility tests performed by raw material supplier 
2003010708- 01; Laboratory No. 
249167). 
Sealing plug 
Line organizer 
Patient connector  
Glucose connector  
Tube rings  
Västra Karaby Plast (VKP) 
 
Custom made components 
PVC AM22W17 from TPV Compound 
S.R.L. 
 
PVC AM22W17 material complies with USP VI test requirements, and 
fulfills the following ISO10993:2018 test requirements: 
• 
Sensitization. 
• 
Intracutaneous irritation. 
• 
Acute systemic toxicity. 
• 
Hemolysis. 
• 
Genotoxicity. 
Tubing 
 
National Bredaryd 
 
Custom made 
PVC 
HY-VIN XH77863 Sh 62 and  
HY-VIN XH79214 Sh 68 from Ineos 
 
Material XH77863 fulfills USP class VI and ISO 10993:2018 cytotoxicity 
tests requirements. Material XH79214 consists of the same 
ingredients at slightly different concentration levels.  

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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2.6.3 
Carry Life UF Carrying bag 
The cycler is placed in a plastic (polyurethane) carrying bag during treatment. 
2.6.4 
Peritoneal dialysis solution 
The peritoneal cavity is pre-filled with a standard Baxter 1.36% glucose-based PD solution (Dianeal or 
Physioneal) before treatment with the Carry Life® UF device is initiated.   
2.6.5 
Glucose solution  
The Carry Life® UF system is designed to be used with a standard Fresenius Kabi 50% glucose solution 
in a 500 ml soft polypropylene FreeFlex bag with injection port, suitable for connection to the spike 
connector of the Carry Life® UF line set.  
2.7 SUMMARY OF REQUIRED EXPERIENCE/TRAINING 
The participating clinical investigation sites are required to be experienced in the treatment of 
patients receiving PD therapies for ESKD. The medical care of patients with ESKD is commonly 
prescribed and supervised by a nephrologist and usually involves a dedicated clinical PD team. This is 
the case for all the sites participating in the study.  
 
To use the Carry Life® UF system in the dialysis clinic, training in the set-up and handling of the device 
is required. A description of the therapeutic principles of the device and the specific training 
requirements will be outlined in connection with the site initiation visit. Training sessions will be 
scheduled and performed according to the IFU by Triomed AB, or their representative. 
 
A site-specific PD nurse will be responsible for managing the connections to the PD catheter and for 
performing and managing the baseline and Carry Life® UF treatments at the clinic as well as assessing 
the subject’s device competency before the home phase of the study. Training of the patient may be 
performed by a Triomed representative under the supervision of the dialysis clinic or by a dialysis 
clinic team member who has been adequately trained in the Carry Life® UF system. 
 
A Triomed representative will be available at the clinic to assist with device related questions during 
the first Carry Life® UF treatment(s) at each clinic, if requested by the clinic. Documentation of the 
training format and the participants will be contained in the training log in the investigator site file 
(ISF) and in the trial master file (TMF). 
2.8 DESCRIPTION OF SPECIFIC MEDICAL PROCEDURES INVOLVED IN THE USE OF THE 
INVESTIGATIONAL DEVICE 
There are no specific medical procedures required for use of the Carry Life® UF system. 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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3 RATIONALE FOR THE DESIGN OF THE CLINICAL INVESTIGATION 
3.1 BACKGROUND 
Chronic kidney disease (CKD) poses a high economic burden for health care systems and to 
individuals affected by the disease. The causes of CKD are many and can be due to age related 
decline of renal function compounded by hypertension, diabetes, and primary renal disorders. The 
global prevalence of CKD is estimated to be between 11-13%.1 
 
CKD can progress to ESKD where dialysis therapy or a kidney transplant is required. PD has been used 
for treatment of ESKD for more than thirty years and despite that many patients choose PD as their 
initial therapy of choice, as many as 35% are reported to transfer to hemodialysis (HD) yearly.2 Issues 
that may cause patients to leave PD are multifactorial and include: peritonitis, inadequate dialysis, 
catheter related problems, patient burn-out, and fluid overload due to insufficient UF. The Carry 
Life® UF system aims to provide an effective management of fluid overload which is associated with 
increased mortality, hospitalization and technique failure.  
3.2 OVERVIEW OF FLUID OVERLOAD IN PATIENTS USING PD THERAPIES 
The prevalence of fluid overload in PD patients is in the range of 56-73%,3-5 with 25% of patients 
expressing severe fluid overload.5 Fluid overload in PD patients occurs when an insufficient amount 
of fluid is removed by the kidneys and the dialysis regimen, and is associated with increased 
mortality and technique failure.6,7 Changes in peritoneal membrane transport characteristics are 
associated with decreased UF over time, e.g., due to faster reduction of glucose levels in the 
dialysate.6,8 Moreover, as ESKD patients experience a reduction in residual renal function (RRF) 
during course of time, an effective peritoneal UF becomes even more important as the dialysis 
treatment should optimally compensate for the potential decrease in urine production. 
 
Fluid overload in PD patients can manifest as generalized edema, pulmonary congestion, and 
hypertension. It contributes to left ventricular hypertrophy and is a major contributor to 
cardiovascular disease, the leading causes of death in all dialysis patients. It is also associated with 
hypoalbuminemia, malnutrition, inflammation, and atherosclerosis and is a significant contributor to 
technique failure.  
 
The assessment of fluid status is often based on clinical examination and the target body weight (so 
called “dry weight”), which represents a state of normal blood pressure and the absence of edema. 
Fluid status may further be determined by: bioimpedance, serum levels of B-type natriuretic peptide 
(BNP), and ultrasound of the inferior vena cava or lungs.9  
 
Causes of fluid overload in PD therapies are multifactorial and can be a combination of the following: 
1. Inappropriate PD prescription for the membrane transport status. 
2. Long glucose-containing daytime or nocturnal dwells. 
3. Failure to use icodextrin solutions. 
4. Inadequate sodium removal. 
5. Non-compliance with PD prescription regarding salt and fluid restriction. 
6. Loss of residual renal function. 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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7. Peritoneal membrane deterioration associated with the use of hypertonic glucose-based PD 
solutions. 
8. Catheter malfunction.  
3.3 CURRENT STRATEGIES TO MANAGE FLUID OVERLOAD 
General measures to treat fluid overload in PD entail: regular assessment of the peritoneal 
membrane and the adjustment of PD regimes to meet clinical needs, patient education, frequent 
clinical assessment, control of blood glucose, regular assessment of RRF, and the correcting of 
catheter problems. 
 
Increased fluid removal in PD patients can be achieved by the following: 
1. Maximizing the osmotic gradient by using higher tonicity dwells (e.g., 3.86% glucose). 
2. Shorter duration dwells (e.g., automated peritoneal dialysis [APD]).  
3. Larger dwell volumes.  
4. An osmotic agent with a higher reflection coefficient (e.g., icodextrin). 
5. Increasing urine output (e.g., diuretics). 
Maximizing the osmotic gradient increases UF, due to the glucose concentration being sustained for 
a longer period of time. However, this may be problematic as it may increase the glucose absorption 
(Table 4) and can contribute to or aggravate metabolic disturbances, such as hyperglycemia, 
hyperinsulinemia, insulin resistance, dyslipidemia and the promotion of obesity.10 
  
Table 4. The approximal absorption of glucose in high/high average transports with different 
glucose concentrations during a 4-hour dwell  
Absorption of glucose with different glucose concentrations PD solutions 
Concentration 
Glucose/2 liters 
Absorption  
Absorption 4 
exchanges/day 
Caloric load  
(3.7 kcal/g glucose) 
1.36% Glucose 
27.2 g/2 liter 
19 g 
76 g/day 
281 calories/day 
2.27% Glucose 
45.4 g/2 liter 
32 g 
128 g/day 
473 calories/day 
3.86% Glucose 
77.2 g/2 liter 
54 g  
216 g/day 
799 calories/day 
 
Another factor of importance for glucose absorption is the characteristics of the peritoneal 
membrane. The transport across the peritoneal membrane is classified as slow to fast transport 
characteristics as is determined by a peritoneal equilibrium test (PET). The clinical impact of the 
transport characteristics is associated with how rapidly the glucose is absorbed and the solutes 
equilibrate. Patients with a  fast transport characteristics require frequent exchanges with short 
duration dwells to preserve the glucose concentration as they absorb glucose rapidly, whereas 
patients with low transport characteristics utilize longer dwells as the dialysate glucose concentration 
and hence the UF are maintained for longer periods.9 It is, however, recommended that dialysis 
regimes routinely utilizing 3.86% glucose PD solutions should be avoided and icodextrin is proposed 
as a once-a-day alternative to hypertonic PD solutions.11 Icodextrin is iso-osmolar and induces UF by 
its oncotic effect. It is mainly absorbed via the lymphatic system and since this absorption is much 
slower than the absorption of glucose the oncotic effect and hence the UF will be sustained for a 
longer period of time. Icodextrin is used for long dwells as it is less effective than glucose when used 
for shorter dwell times.  The effect on peritoneal UF of increasing the dwell volumes in PD therapies 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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tends to be modest, possibly because of the increased intraperitoneal (IP) pressure which tends to 
increase fluid absorption. 
 
The urinary output is important in dialysis patients and one of the advantages with PD compared to 
HD is that RRF is better preserved.9 The loss of urinary output varies over time and clinically 
significant changes can occur rapidly. Strategies to preserve RRF and urinary output include the use 
of diuretics and the avoidance of episodes of dehydration. PD patients who are overhydrated and 
consistently achieve a daily peritoneal UF of less than 750 ml should be closely monitored and may 
benefit from a change in modality.11 In the management of fluid status it is recommended that the 
peritoneal membrane function, the RRF, and the achieved UF volumes are monitored regularly.11 
Fluid overload is a complex issue in PD therapies and there is an unmet need for a more effective 
peritoneal fluid removal which could be provided by the Carry Life® UF system.  
3.4 PERITONEAL ULTRAFILTRATION AND SURVIVAL 
During the past decades the importance of peritoneal UF has emerged as a major factor for patient 
and technical survival of PD patients, whereas previously more attention was put on the clearance of 
uremic toxins.4 Indeed, observational studies have consistently shown that reduced peritoneal UF is 
associated with increased mortality.12-15 
 
In a non-anuric PD population, fluid removal was shown to be related to survival, total 
hospitalization, and cardiovascular hospitalization.12 In this study, 125 PD patients were followed for 
three years from the start of treatment. Based on quartiles for total fluid removal, the patients were 
divided into four groups and the survival for each group was analyzed. In summary the study showed 
that the three-year patient survival rates were different among the groups, with a survival rate of 
61.5% in the patients with a total fluid removal in the 1st quartile (<1265 ml/24 h/1.73 m2), while for 
patients in the 4th quartile (>2035 ml/24h/1.73m2) the survival was 96.3%. The peritoneal UF volume 
was on average found to constitute 78% of the total fluid removal.  
 
In anuric PD patients, studies have shown that UF volumes below 0.75 L/day13 and below 1.0 L/day15 
are associated with decreased survival. In the NECOSAD study14, peritoneal UF was significantly 
associated with mortality in anuric patients. In the EAPOS study13, the two-year survival was 
approximately 83% in patients with an UF volume above 750 ml/day compared to about 57% in 
those with an UF volume below 750 ml/day, i.e., about 26 percentage points higher. In a multivariate 
Cox regression model, baseline UF volume was shown to be a significant predictor of survival. In the 
study by Lin et al., the four-year survival in patients with an UF volume of ≥1 L24h was approximately 
53% compared to about 16% in patients with an UF volume <1 L/24h, i.e., about 37% higher.15 
Median survival was 42.4 vs 27.2 months in the in the two groups, respectively. In a multivariate Cox 
regression analysis, the relative risk of death per daily 100 ml UF difference was 0.80 (p<0.001). In 
anuric PD patients, targets for peritoneal UF volumes of 0.75 - 1.0 L/day have been suggested by 
international guideline bodies.11,16 
3.5 PERITONEAL GLUCOSE LOAD 
The most common osmotic agent used for PD is glucose. Glucose, or its degradation products, are 
believed to have a negative impact on the peritoneal membrane integrity, and the significant 
peritoneal glucose absorption of up to 200 g of glucose per day13 that may  occur with glucose-based 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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PD is associated with systemic and metabolic effects such as insulin resistance, new onset diabetes 
and cardiovascular disease, as well as mortality9,10,16,17. Therefore, the objective of PD must be to 
obtain the required UF with as low glucose absorption possible, i.e., using a method that optimizes 
the glucose UF efficiency.  
3.6 PERITONEAL SODIUM REMOVAL 
Adequate sodium balance is crucial for the management of PD patients. Low sodium removal in PD 
patients is associated with increased mortality and hospitalization.18 An efficient peritoneal sodium 
removal is complicated by the phenomenon known as sodium sieving. Sodium sieving occurs when 
water is transported through the aquaporins in the peritoneal membrane, which does not allow 
passage of electrolytes. Thereby sodium is retained in the blood and the UF fluid generated is 
hypotonic with regards to sodium. Sodium retention is associated with the use of glucose as the 
osmotic agent and in particular when using high glucose strength PD solutions. The sodium retention, 
results in a reduced dialysate sodium concentration, which enables sodium to move more efficiently 
over the membrane via diffusion. If the dwell is maintained for a duration sufficient for the dialysate 
sodium concentration to reach a level close to the blood sodium concentration the net sodium 
retention is minimized. 
 
APD is characterized by shorter dwell times than CAPD; after approximately 40–90 minutes the fluid 
is typically exchanged with fresh PD solution. This may increase the UF volume and the removal of 
uremic toxins, but comes at the expense of sodium removal4,19,20 as the dialysate is not allowed 
sufficient time to equilibrate, which results in the removal of a sodium hypotonic UF fluid. 
3.7 EXPLORATORY STUDIES WITH MAINTAINED INTRAPERITONEAL GLUCOSE CONCENTRATION 
Therapeutic concepts similar to the Carry Life® UF system such as continuous flow PD (CFPD) and 
steady concentration PD (SCPD) have been described in the literature. The features of CFPD are that 
the IP volume is fixed and that dialysate rapidly and continuously flows in and out of the peritoneal 
cavity, creating a stable IP glucose concentration. Studies performed with CFPD have demonstrated 
that CFPD results in a significantly higher UF volume compared to standard PD therapies.  
In the study on adult PD patients by Freida et al.21 the UF volume in the PET (2.27% glucose), 
achieved 270 mL, whereas the mean UF in CFPD was 587 mL with a 1.36% PD solution. UF and net 
sodium removal extrapolated to eight hours of treatment was also much higher with CFPD (1175 ml 
UF; 212 mmol sodium removal) compared to 8 hours APD treatment APD (427 ml UF; 66 mmol 
sodium removal). Glucose absorption was not significantly different between the CFPD and APD 
session but the glucose UF efficiency (UF/absorbed glucose) was higher with the CFPD (33.5 ml/g) 
compared to APD (11.4 ml/g). 
 
In a study by Pérez-Díaz a PD treatment concept close to that of the Carry Life® UF system was 
used.22 In the study a 50% glucose solution, at a dose of 20-30 g/h, was continuously administered to 
the IP fluid during four-hour dwells in PD patients with symptomatic fluid overload that could not be 
adequately treated with available PD methods. IP glucose concentrations at the end of the PD dwell 
was 1.89 ± 0.42%. The highest IP glucose concentration was 2.7%. The treatment reversed all 
episodes of fluid overload, and serum glucose levels were stable and remained within safe levels 
during the study. The SCPD achieved high UF volumes in the four-hour sessions (653 ± 363 ml/4 h) 
and achieved twice the UF volume compared to the patients’ PET tests (300 ± 251 ml/4 h) and 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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6 times that of their regular PD regime (100 ± 123 ml/4 h). The achieved UF volumes varied in the 
study participants, despite identical treatments being performed, which was partly explained by a 
correlation of UF to fluid overload. The conclusion of the Pérez-Díaz study was that SCPD may 
provide an effective and safe tool to manage UF in PD, opening new therapeutic possibilities to 
optimize and increase the flexibility of PD treatments.22  
 
Conclusions of the reviewed literature for CFPD and SCPD are that when a stable IP glucose 
concentration is maintained during the PD dwell the UF is increased compared to standard PD 
therapies. CFPD is also associated with a higher sodium removal and a more efficient use of the 
glucose. 
3.8 CLINICAL EXPERIENCE WITH THE CARRY LIFE® UF DEVICE 
Two clinical studies have been performed with the Carry Life® UF device in PD patients (Tmed-004 
and Tmed-007). The therapeutic concept of both clinical investigations was to maintain a stable IP 
glucose concentration to achieve peritoneal UF.  
 
In Tmed-004, a 20% glucose solution was used and a glucose dose of approximately 10 g/h was 
administered during the 8-hour treatments. Five patients were included in the study and two 
treatments were performed for each patient. A stable IP glucose concentration of around 1.27% was 
maintained throughout the treatment. The average UF volume with the Carry Life® UF treatment was 
586 ± 685 ml which compared with the patients’ average UF volume of 860 ± 640 ml for 24 hours. 
The Carry Life® UF hence achieved an UF volume in eight hours in the same range as the UF volume 
normally achieved by the patients 24-hour CAPD regime. However, there was high variability in the 
UF volume outcome, both between patients and between the two treatments for the same patient. 
 
Due to the high variability in UF outcome in the Tmed-004 study, the Carry Life® UF glucose dose 
setting was adjusted to enable a glucose dose up to 20 g/h. The system software (SW) was updated 
for use with a 50% glucose solution instead of the 20% glucose solution. The Tmed-007 study was 
performed with the updated device in order to determine the UF efficacy of three different glucose 
doses (11, 14, and 20 g/h) during a 5-hour treatment in comparison to a standard 4-hour 2.27% 
glucose CAPD dwell. The study included eight subjects of high (H) and high average (HA) peritoneal 
membrane transport characteristics and the results showed a significantly increased UF volume 
compared to the 2.27% CAPD dwell at all three doses. The UF volume with the Carry Life® UF 
treatment was 646 ± 256, 739 ± 312, and 863 ± 380 ml with the 11, 14, and 20 g/h glucose doses, 
respectively, compared with 162 ± 242 ml for the control CAPD dwell. Glucose UF efficacy was 
significantly higher with Carry Life® UF treatments, being 17.0 ± 10.6, 14.5 ± 7.7 and 12.4 ± 6.8 ml 
UF/g glucose absorbed with the 11, 14 and 20 g/h glucose doses, respectively, compared with 
standard 5.9 ± 7.8 ml UF/g glucose absorbed with the control CAPD dwell. The sodium removal was 
proportional to the fluid removal, resulting in a sodium removal with the Carry Life® UF treatments 
which was 4-5 times higher than the CAPD dwell (86 ± 27, 92 ± 33, 110 ± 37 mmol/treatment with 
the 11, 14 and 20 g/h glucose doses, respectively, vs. 21 ± 33 mmol/treatment with the control CAPD 
dwell). The dialysate glucose concentration was maintained between 1.6% to 2.2% glucose 
throughout the treatments in a dose dependent manner. 
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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There were no incidents of adverse therapy or adverse device effects in Tmed-004. In Tmed-007 
there was one adverse device effect where the subject felt light-headed after the 11 g/h Carry Life® 
UF treatment. The incident resolved after a short rest. All patients tolerated the treatment well and 
there was no discomfort associated with the intermittent transfer of IP fluid during the 
investigations.  
 
Since the Tmed-007 study, the Carry Life® UF cycler has been updated in order to improve the 
robustness and usability of the system, including:  
• 
The auto-drain function has been added. 
• 
The highest dose of 20 g/h has been removed. There are now two glucose doses, 11 g/h and 
15 g/h instead of the 11, 14 and 20 g/h doses that were used in the Tmed-007 study. 
• 
The SW has been updated in accordance with the updated functionality and in order to avoid 
false alerts. 
• 
The user interface (hand control) has been updated. 
• 
The pinch valves have been made more robust. 
• 
The cycler chassis is modified to improve usability. 
 
Please also refer to the IB for a further description of the device updates that was done after the 
Tmed-007 study. 
3.9 RATIONALE FOR THE CLINICAL INVESTIGATION  
 
The Carry Life® UF system has been verified and validated according to Triomed’s quality system and 
meets applicable regulatory standards. Verifications and validations have been performed for the 
following system components: 
• 
Line set. 
• 
Labeling. 
• 
Software. 
• 
Cycler and System. 
 
For details on the verification and validation testing, refer to the IB. 
 
The following conclusions for the verification and validation testing has been made: 
 
Line set: 
All verification and validation testing performed on the Carry Life® UF line set met pre-determined 
acceptance criteria as defined in design inputs, product specifications, and applicable standards.  The 
line set performed as expected and all testing results suggest with high statistical probability that the 
device will perform as intended in the clinical environment.  None of the deviations from prescribed 
methods in the protocol adversely affected the outcome of the tests.   
 
Labeling: 
All verification and validation testing performed on the Carry Life® UF labeling met pre-determined 
acceptance criteria as defined in design inputs, product specifications, and applicable standards.    
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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Software:  
All verification and validation testing performed on the Carry Life® UF software met pre-determined 
acceptance criteria as defined in design inputs, product specifications, software requirements, 
software design documents and applicable standards.  The software performed as expected and all 
testing results indicate that the device is expected to perform as intended in the clinical 
environment.  None of the deviations from prescribed methods in the protocol adversely affected 
the outcome of the tests.   
 
Cycler / system conclusion: 
All verification and validation testing performed on the Carry Life® UF cycler and system met 
pre-determined acceptance criteria as defined in design inputs, product specifications, and 
applicable standards.  The cycler and system performed as expected and all testing results suggest 
with high statistical probability that the device will perform as intended in the clinical environment.  
None of the deviations from prescribed methods in the protocol adversely affected the outcome of 
the tests. 
 
The previous clinical investigation Tmed-007 showed in eight PD patients that the Carry Life® UF 
treatment, at glucose doses between 11 g/h and 20 g/h, can be used to significantly increase the UF 
volume, increase the peritoneal sodium removal and increase the glucose UF efficiency (i.e., more UF 
per glucose amount absorbed) compared to a 2.27% CAPD dwell. The study also showed that the 
device was safe to use in a clinical setting when handled by PD nurses. The Carry Life® UF system is 
intended for use by the patient or caretaker in the home environment.  
 
The aim for the present clinical investigation is: 1) to show that a Carry Life® UF treatment performed 
by the patient (or caregiver, if a caregiver normally assists the subject’s PD treatment) in the home 
environment generates an increased UF compared to the control treatment and 2) to evaluate the 
overall safety of the Carry Life® UF treatment when incorporated in the subjects’ current CAPD 
regime in the home environment and when used by the patient/caregiver in the home environment. 
 
The proposed design of the clinical investigation is a crossover study where all subjects will perform 
both the control arm, which includes a baseline PD regimen including one 2.27% CAPD day dwell, and 
the Carry Life® UF treatment arm.  Subjects will start with either the control arm or Carry Life® UF 
arm based on the randomization.  During the Carry Life® UF arm one 2.27% glucose CAPD dwell will 
be replaced with Carry Life® UF treatment during three days of the week. For the remaining four days 
of the week, the 2.27% glucose dwell will be replaced by a 1.36% glucose dwell. With this design 
Triomed expect that the subject’s weekly UF volume will be reasonably stable. The PD prescription 
can be changed as required during the study to obtain an adequate fluid removal.  
 
All the steps required for the use of the Carry Life® UF system are described in the IFU. When using 
the Carry Life UF® system at home the patient/caretaker would need to perform the following 
activities listed in Table 5. 
 
The Carry Life® UF System has been validated in a summative usability study on 15 PD nurses and 15 
PD patients. While the report from the study is not completed, there study has passed all acceptance 
criteria including the acceptance criteria of no critical use errors allowed. 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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Table 5. Patient/caregiver activities performed at home to use the Carry Life® UF System 
Activity 
Comment 
Cleaning the work surface. 
Same as before standard CAPD treatment. 
Weighing of solution bags. 
Weighing of solution bags is clinical practice for 
many patients in their standard CAPD treatment. 
Inspecting all disposables and solutions used for 
the treatment. 
Same as for their standard CAPD treatment. 
Setting up the Carry Life UF® system: 
• 
Inserting the battery in the cycler. 
• 
Attaching the line set in the cycler. 
• 
Connecting the glucose bag to the line set 
and attaching glucose bag to cycler. 
• 
Starting the device function check 
(pressing the OK button). 
Training will be performed and patients will be 
required to pass a device competency evaluation by 
a site PD nurse before using the system at home. 
Performing a standard CAPD fill. 
Same as for standard CAPD treatment. 
Attachment of the PD belt. 
Same as for standard CAPD treatment (if they use a 
PD belt). 
Connecting the Carry Life UF® line set to the 
catheter transfer set. 
Similar to what the CAPD patients normally do when 
they perform a PD fluid exchange. Same type of 
connection. 
Securing the patient connection (connection 
between the extension set and Carry Life UF® line 
set) in the PD belt. 
Similar to what the CAPD patients normally do, 
normally the transfer set would be secured in the PD 
belt. 
Priming the Carry Life UF® system (by pressing the 
OK button after function check is completed). 
Training will be performed and patients will be 
required to pass a device competency evaluation by 
a site PD nurse before using the system at home. 
Starting treatment with the Carry Life UF® device 
(after priming is completed).   
Training will be performed and patient will be 
required to pass a device competency evaluation by 
a site PD nurse before using the system at home. 
Managing device alerts (according to description 
and troubleshooting guide in the IFU).  
Training will be performed and patient will be 
required to pass a device competency evaluation by 
a site PD nurse before using the system at home. 
Performing additional drains (not normally 
needed). 
Training will be performed and patient will be 
required to pass a device competency evaluation by 
a site PD nurse before using the system at home. 
Disconnecting from device after completing 
treatment. 
Similar to what the CAPD patients normally do when 
they disconnect after a PD fluid exchange. Same type 
of connection. 
Performing a standard PD drain after treatment. 
Same as for standard CAPD treatment. 
Removing used disposables from the Carry Life UF® 
line set. 
Training will be performed and patients will be 
required to pass a device competency evaluation by 
a site PD nurse before using the system at home. 
Weighing and emptying drain bags after 
treatment. 
The CAPD patients are used to weighing and 
emptying the drain bags. A different scale will be 
used if patient does not normally use a desk top 
scale. 
Discarding of disposables. 
Same as for standard CAPD treatment. 
Removing an and re-charging the Carry Life UF® 
battery in the provided battery charger. 
Training will be performed and patient will be 
required to pass a device competency evaluation by 
a site PD nurse before using the system at home. 
Cleaning the Carry Life UF® cycler and carrying bag. 
Training will be performed and patient will be 
required to pass a device competency evaluation by 
a site PD nurse before using the system at home. 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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4 THE RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE AND 
CLINICAL INVESTIGATION 
4.1 ANTICIPATED CLINICAL BENEFITS  
Carry Life® UF system is intended as a complement to standard PD therapies, performed by the 
patient or a caregiver at home, with the anticipated clinical benefit of improved fluid management 
through an efficient fluid and sodium removal enabled by the sustained IP glucose concentration. 
Inadequate fluid management is associated with technique failure, and higher total fluid removal and 
total sodium removal are both associated with decreased morbidity and mortality in PD patients. 
Introducing Carry Life® UF treatment for PD patients may enable patients to stay longer on PD 
therapy, and allowing for less strict fluid restrictions. By mitigating the need for use of hypertonic 
glucose-based PD solutions, which are associated with peritoneal membrane deterioration resulting 
in higher solute transport and reduced peritoneal fluid removal, the UF capacity of the peritoneal 
membrane may be preserved. 
 
In Tmed-007, the Carry Life® UF doses of 11 and 14 g/h resulted in a dialysate glucose concentration 
around 1.6% and 1.9%, i.e., lower peak glucose concentration than with hypertonic glucose-based PD 
solutions. With lower peak dialysate glucose concentration, the peak glucose absorption rate will be 
lower, which may lead to less impact from the Carry Life® UF treatment on blood glucose levels in 
diabetic patients compared to the standard hypertonic PD-dwells. 
 
Because of the more efficient use of glucose (more UF per amount of glucose absorbed) compared to 
2.27% glucose PD dwells, Carry Life® UF may reduce the total peritoneal glucose uptake from the 
patients PD regimen.  
 
In summary, the clinical advantages of the Carry Life® UF system are: 
• 
UF can be maintained throughout the treatment session leading to a larger fluid removal 
which enables improved volume management.  
• 
An efficient use of glucose, i.e., higher UF volume per amount of glucose absorbed which 
may reduce the total glucose absorption from the PD regimen. 
• 
Increased sodium removal. 
• 
A reduced use of hypertonic glucose PD solutions. 
• 
Increased technique survival. 
4.2 ANTICIPATED BENEFITS FOR PARTICIPANTS 
There are no immediate clinical benefits for the patients participating in the clinical investigation. 
Subjects may achieve increased UF volume during the clinical investigation study sessions compared 
to their standard PD regime and less glucose may be absorbed during the 4 weeks treatment with 
the device at home, however, these benefits cannot be guaranteed. 
 
At present the Carry Life® UF system is not commercially available, and patients will not be able to 
continue with the therapy even if it was shown beneficial in the clinical investigation. When the 
device is commercially available it is intended for the patient population included in the clinical 
investigation.   

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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4.3 ANTICIPATED ADVERSE DEVICE EFFECTS   
The anticipated adverse device effects of the Carry Life® UF system are related to the adverse effects 
of standard PD treatment performed by the patient/caregiver at home, which are well known and 
documented. Table 6 below lists the adverse effects associated with standard PD treatment 
compared to the Carry Life® UF system and the study mitigations.  
 
Table 6. The anticipated adverse events with the Carry Life® UF compared to standard PD 
treatment and their mitigations 
Anticipated adverse 
device effect 
Frequency in standard PD 
treatment 
Estimated relative risk for 
Carry Life® UF vs standard 
PD treatment 
Carry Life® UF risk 
mitigations 
Infection: Exit 
site/catheter tunnel 
infection 
 
Peritonitis  
Exit site and catheter 
tunnel infections are 
major predisposing factors 
for PD related peritonitis 
which is a well-known risk 
associated with PD. 
 
The peritonitis rate is 
between 0.2 to 0.6 
episodes/patient/year, or 
1 episode per 20-60 
patient months of PD. 
Contamination of the fluid 
path may cause infection and 
peritonitis and is primarily 
associated with connections 
of PD bags and line sets 
performed by the user. Carry 
Life® UF system connections 
have been developed in 
order to minimize the risk of 
contamination and the risk is 
therefore assessed as 
comparable to standard PD 
therapies. 
 
Each Carry Life® UF 
treatment adds one patient 
connection, when the 
catheter extension set is 
connected to the Carry Life® 
UF line set. Since flush-
before-fill is utilized with the 
Carry Life® UF system, (the 
PD solution instilled in the 
peritoneal cavity is used to 
flush the system) the added 
risk of contamination is 
assessed as minimal.  
 
Exit site infection and 
catheter tunnel infection may 
be caused by tear at the exit 
site. The connection to the 
Carry Life UF cycler adds a 
risk for pulling of the catheter 
and tear of the exit site 
compared to a standard 
CAPD treatment but may be 
comparable to the risk 
associated with APD 
treatment, where the 
patients also are connected 
The design of line set and 
connectors mitigates the 
risk of contamination. 
 
The system flushes the 
system with IP fluid after 
device connection which 
reduce the risk for 
contamination. 
 
The study subjects 
prevalent CAPD patients 
who performs their 
standard CAPD treatment 
at home and who are 
proficient is aseptic 
techniques. 
 
The subject/caretaker have 
to undergo training on the 
device to ensure they can 
operate the device safely 
and autonomously before 
continuing to the home 
treatment phase. 
 
The IFU contains clear 
instructions regarding the 
use of aseptic technique 
with the system. 
 
The length of the patient 
line and securing of the 
patient connection in a PD 
belt mitigates the risk for 
pulling of the catheter and 
tearing of the exit site. The 
securement of the patient 
connection in the PD belt 
has been verified to 
prevent pulling of the 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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Anticipated adverse 
device effect 
Frequency in standard PD 
treatment 
Estimated relative risk for 
Carry Life® UF vs standard 
PD treatment 
Carry Life® UF risk 
mitigations 
to a device throughout the 
treatment. 
catheter in case the cycler 
is dropped. 
Fibrosis of the 
peritoneal 
membrane 
Deterioration of the 
peritoneal membrane is a 
long-term consequence of 
PD. 
The risk with the Carry Life® 
UF system is possibly lower 
as the peritoneal membrane 
is exposed lower peak 
dialysate glucose 
concentration. 
N/A 
Hernia 
Hernia occurs in 10-20% of 
PD patients at some point 
during the treatment 
period due to the 
intraperitoneal fluid 
volumes. 
The same or lower as 
standard CAPD as the system 
remove dialysate from the 
system hourly during 
treatment which based on 
the Tmed-007 study prevents 
an increase in IP volume in 
most patients. 
Hourly drains to limit 
increases in IP volume 
resulting from the UF fluid. 
Encapsulating 
peritoneal sclerosis 
Encapsulating peritoneal 
sclerosis is a rare but 
devastating complication 
of long-term PD occurring 
in 1-3% of PD patients, 
usually after 
approximately 5 years of 
PD therapy. The 
mechanism of this 
complication is unclear, 
but the duration of PD 
therapy is the strongest 
risk factor. 
The same as for standard PD. 
None. 
Metabolic 
disturbances due to 
glucose absorption 
Glucose based PD results 
in significant amounts of 
glucose being absorbed 
50-150 g daily. This may 
contribute to weight gain 
and lipid abnormalities in 
PD patients. 
The same as for standard PD.  
The baseline CAPD 
prescription (2.27% 
glucose dwells) is replaced 
by 1.36% glucose dwells. 
Glucose absorption is 
expected to be comparable 
with the Carry Life® UF 
system and the standard 
CAPD prescription. 
Hyperglycemia 
In diabetic patients, 
peritoneal glucose 
absorption results in 
poorer glycemic control 
and adjustment of or 
initiation of blood glucose 
lowering medication may 
be needed. While data are 
limited one study indicate 
that 8% of non-diabetic 
patients become diabetic 
The same as for standard PD. 
The patients’ standard PD 
treatment is modified so 
that the subject’s weekly 
glucose exposure will be 
comparable when the 
Carry Life® UF system is 
used. 
 
Blood glucose levels will be 
frequently measured 
during the in-clinic phase 
of the study. 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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Anticipated adverse 
device effect 
Frequency in standard PD 
treatment 
Estimated relative risk for 
Carry Life® UF vs standard 
PD treatment 
Carry Life® UF risk 
mitigations 
after start of PD therapy 
(8). 
 
Diabetic subjects will 
monitor and manage their 
blood glucose levels 
according to their standard 
diabetes management. 
After starting to use the 
Carry Life® UF device at 
home, blood glucose levels 
will be evaluated daily by 
the clinic for at least three 
days until judged clinically 
stable and thereafter 
weekly. 
 
Altered 
concentrations of 
electrolytes in blood 
>10% of patients treated 
with hourly exchanges of 
hypertonic PD solution 
develops hypernatremia 
due to sodium retention. 
10-30% of PD patients 
have hypokalemia, which 
may be due to PD removal 
of potassium, glucose 
absorption, or other 
reasons not related to PD. 
Insufficient calcium 
removal is common in PD. 
Low-calcium PD solutions 
are available to increase 
calcium removal during 
PD. 
Same as for standard PD.  
 
 
Concentration of 
electrolytes in blood will 
be measured at start of 
study (Visit 1) and after 
each study arm. 
 
 
Peritoneal protein 
loss 
6-8 g of protein are lost 
daily by PD, which may 
result in a decrease in 
serum albumin. 
Same as standard PD. 
None. 
Hemodynamic 
instability due to 
increased peritoneal 
UF 
This is a rare adverse 
event of standard PD. 
As Carry Life® UF is intended 
to increase UF rates, 
compared to standard PD 
treatment the risk for 
hemodynamic instability may 
be increased. No issues of 
hemodynamic instability have 
been observed during 
previous clinical 
investigations with the Carry 
Life® UF device, also at higher 
glucose doses. 
 
The risk during the clinical 
investigation is mitigated 
by the design of the 
investigation: the glucose 
dosage during the in-clinic 
phase starts at the lowest 
dose and symptoms of 
hemodynamic instability 
will be monitored. Subjects 
will not be allowed to 
continue in the study if 
they experience a systolic 
blood pressure below 100 
mmHg during the in-clinic 
treatment phase of the 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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Anticipated adverse 
device effect 
Frequency in standard PD 
treatment 
Estimated relative risk for 
Carry Life® UF vs standard 
PD treatment 
Carry Life® UF risk 
mitigations 
study or generates a UF 
rate higher than 20 ml/lg 
body weight/5-hour 
treatment.  
 
A systolic blood pressure 
below 100 mmHg and 
clinical signs of 
dehydration are used as 
exclusion criteria in the 
study. 
Increased 
intraperitoneal 
pressure due to 
increased UF 
This is a rare occurrence in 
APD and is mitigated by 
performing a complete 
drainage mid treatment.  
Comparable to APD 
treatment. 
The subjects will for the 
Carry Life® UF treatments 
use the same fill volume as 
in their standard PD 
treatment. 
 
Hourly drainage is 
performed during the 
study sessions, thereby 
reducing the risk for 
increased intraperitoneal 
pressure and there is a 
complete peritoneal drain 
at the end of the 5-hour 
treatment session. 
The subject will not be 
allowed to continue the 
study if a UF rate higher 
than 20 ml/kg body 
weight/5-hour treatment 
occurs during the in-clinic 
phase. 
Blood concentration 
of dialyzable drugs 
can be reduced 
This is a known adverse 
effect and adjustment to 
medications are 
performed accordingly. 
Comparable to other PD 
therapies. 
None. 
Shoulder or 
abdominal pain due 
to infusion of air in 
the peritoneal cavity 
Pneumoperitoneum is not 
uncommon in CAPD 
patients and the main 
reason is user error during 
the PD bag exchange. 
Comparable to CAPD 
treatment. 
 
The Carry Life® UF 
treatment cannot be 
started if priming, which 
removes the air from the 
line set before use, has not 
been performed. 
 
The anticipated adverse device effects which are particularly relevant when using the Carry Life® UF 
device are related to the therapeutic mode of action (enhancing UF volumes by maintaining a stable 
IP glucose concentration). 
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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The possible anticipated adverse events and their mitigation are:  
• 
That increased UF volumes may result in hemodynamic instability such as hypotension 
during Carry Life® UF study sessions. Mitigation: Blood pressure and generated UF rate will 
be assessed according to a pre-defined procedure during the in-clinic treatment phase. Blood 
pressure and heart rate will be measured before and after the Carry Life® UF study sessions 
and additionally if clinically indicated. If the patient becomes hemodynamically instable 
during the Carry Life® UF study session, the session will be discontinued, and the patient 
returned to their normal treatment. 
• 
That glucose absorption may increase the blood glucose levels. Mitigation: Blood glucose 
levels will be monitored during the in-clinic visits and blood glucose will be regularly 
monitored in diabetic patient during the home treatment phase of the study.  
• 
That the IP volume is increased due to the enhanced UF. During the Carry Life® UF study 
sessions there will be hourly drains of the IP volume, and additional drains can be performed 
at any time if the patient experiences discomfort.  
4.4 RESIDUAL RISKS ASSOCIATED WITH THE DEVICE  
A risk analysis of the Carry Life® UF system has been performed according to ISO 14971:2019 and is 
available in Appendix C of the IB. The Carry Life® UF system complies to identified applicable 
regulatory standards and the risk analysis shows that the usage of the Carry Life® UF does not entail 
unacceptable risks. 
 
The residual risks associated with the device have been reduced to an acceptable level or as a low 
level as reasonably possible. Further mitigation will not improve safety. The risk level for 
contamination is comparable to conventional PD therapies. From a general risk-benefit perspective, 
the risk posed by the clinical investigation performed by the Carry Life® UF system is acceptable and 
comparable to standard methods of PD.   
4.5 RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL INVESTIGATION AND 
MITIGATION 
Risks associated with participation in the clinical investigation have been evaluated according to 
ISO 14971:2019. Risks with the clinical investigation are similar to standard CAPD treatment including 
hyper-or hypovolemia, hyper-or hypo glycemia, as well as risk associated with blood sampling. Risks 
of additional blood sampling, PET/CAPD dwell during in-clinic phase, and Carry Life UF® treatments in 
clinic, will be performed by healthcare professionals at the PD clinic according to routine clinical 
procedures. Risks associated with Carry Life UF® treatments at home during the home treatment 
phase will be mitigated by PD patients being trained in aseptic technique and on the Carry Life UF® 
treatment, furthermore a study nurse shall be present during the preparation and initiation of the 
first at home treatment. Diabetic patients on insulin frequently monitor blood glucose levels 
according to their regular diabetes management and are familiar with early symptoms of 
hypo-/hyper-glycemia and how to manage this. 
 
Refer to Table 6 for a list of adverse effects associated with PD compared to the Carry Life® UF 
system and their study mitigations. 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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4.6 POSSIBLE INTERACTIONS WITH CONCOMITANT MEDICAL TREATMENTS  
A concomitant therapy is any drug or substance administered between the time the patient has has 
been enrolled and the completion of the follow-up/end of the clinical investigation. Adjustments to 
medication regimes can be performed at the discretion of the Investigator and should be 
documented in the electronic case report form (eCRF) (assessments/evaluations) and medical 
records. Blood concentration of dialysable drugs can be reduced by PD but no change is expected 
when introducing the Carry Life® UF system as the amount of PD fluid used will not be changed 
during the study. Glucose has no known drug interaction with the Carry Life® UF system.   
4.7 BENEFIT TO RISK RATIONALE 
Based on the above assessments of the benefits and risks with the Carry Life® UF system, it can be 
concluded that the benefits exceed the risks for patients included in the clinical investigation and 
may significantly benefit future PD patients. The risks associated with the study treatment are the 
same as the risks associated with standard PD therapies.  
 
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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5 OBJECTIVES OF THE CLINICAL INVESTIGATION  
5.1 OBJECTIVES 
5.1.1 
Primary objective 
The primary objective of the clinical investigation is: 
• 
To demonstrate that a 5-hour Carry Life® UF treatment at home results in an increased UF 
volume compared to a 5-hour 2.27% glucose CAPD dwell in adult CAPD patients.   
5.1.2 
Secondary objectives  
The secondary objectives of the clinical evaluation are: 
• 
To evaluate the overall safety of the Carry Life® UF system used by the patient at home as 
measured by rates of adverse events (AEs) and serious adverse events (SAEs) in adult CAPD 
patients. 
• 
To demonstrate that treatment with the Carry Life® UF system at home results in increased 
sodium removal compared to a 2.27% glucose CAPD dwell in adult CAPD patients. 
• 
To demonstrate that treatment with the Carry Life® UF system at home results in a more 
glucose efficient peritoneal fluid removal compared to a 2.27% glucose CAPD dwell in adult 
CAPD patients. 
• 
To evaluate if the peak glucose concentration during a Carry Life® UF treatment is lower than 
the glucose concentration of a 2.27% glucose PD solution. 
5.1.3 
Exploratory objectives  
The exploratory objectives of the clinical evaluation are: 
• 
Evaluation of peritoneal urea and creatinine removal. 
• 
Evaluation of overall weekly UF based on the patient diary. 
5.2 HYPOTHESES TO BE ACCEPTED OR REJECTED BY STATISTICAL DATA FROM THE CLINICAL 
INVESTIGATION 
Primary endpoint hypothesis 
The UF volume achieved with the Carry Life® UF system is superior compared to the UF volume 
achieved with CAPD using a 2.27% glucose PD solution during a 5-hour treatment.   
:             H0: µd ≤ δ 
              H1: µd > δ 
Where µd is the average paired difference in UF volume and δ is the superiority margin of 250 ml. 
 
Where H0 is rejected if the following is true: 
 
 (𝜖̂ −𝛿)
𝜎̂𝑚 
√2𝑛
< 𝑡𝛼,2𝑛−2 
 
 
 
 
Hypothesis: 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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Secondary endpoint hypotheses 
Peritoneal sodium removal: The peritoneal sodium removal achieved with the Carry Life® UF system 
is larger than the peritoneal sodium removal achieved with CAPD using a 2.27% glucose PD solution 
during a 5-hour treatment.   
 
Hypothesis:  
H0: µCL  ≤  µCAPD  
H1: µCL > µCAPD 
Where µCL is the average paired Carry Life® UF peritoneal sodium removal and µCAPD is the average 
paired CAPD peritoneal sodium removal. 
 
Glucose UF efficiency: The glucose UF efficiency (ml UF volume / g glucose absorbed) achieved with 
the Carry Life® UF system is higher than the glucose UF efficiency achieved with CAPD using a 2.27% 
glucose PD solution during a 5-hour treatment. 
 
Hypothesis:  
H0: µCL ≤  µCAPD  
H1: µCL > µCAPD 
Where µCL is the average paired Carry Life® UF glucose UF efficiency and µCAPD is the average paired 
CAPD glucose UF efficiency. 
 
Peak dialysate glucose concentration: 
H0: PeakCL dialysate glucose concentration ≥ 2.27% 
H1: PeakCL dialysate glucose concentration < 2.27% 
Where peakCL is the highest measured dialysate glucose concentration during the Carry Life® UF 
treatment (T1h to T5h). 
 
AEs and SAEs: 
There is no statistical test for the safety endpoint. The AEs will be tabulated and described in detail. 
 
5.3 CLAIMS OF PERFORMANCE OF THE DEVICE  
Claims and intended performance of the investigational device to be verified include: 
• 
A larger UF volume can be obtained compared to a standard 2.27% glucose CAPD dwell. 
• 
A larger sodium removal can be obtained compared to a standard 2.27% glucose CAPD 
dwell. 
• 
The device maintains the intraperitoneal glucose concentration throughout the 
treatment.  
• 
The glucose concentration is maintained below 2.27% i.e., below the glucose 
concentration of a medium strength glucose PD solution. 
• 
The system prevents increases in intraperitoneal volume by hourly drainage of 
approximately 180 ml of dialysate. 
• 
The glucose UF efficiency (ml UF / g glucose absorbed) is improved compared to a 
standard 2.27% glucose CAPD dwell. 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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5.4 RISKS AND ANTICIPATED ADVERSE DEVICE EFFECTS TO BE ASSESSED  
Anticipated adverse device effects are contained in Section 4.3 and the specific adverse device 
effects for evaluation are as follows: 
• 
Adverse device effects associated with excessive UF volumes: 
o Hypotension. 
o Weight reduction below target weight. 
o Other clinical symptoms of dehydration. 
o Reduced residual renal function. 
o Changes in blood chemistry (electrolytes, glucose, albumin, parathyroid hormone 
[PTH]). 
• 
Adverse device effects associated with glucose absorption/inadequate diabetes 
medication: 
o Hyperglycemia.  
o Hypoglycemia. 
 
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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6 DESIGN OF THE CLINICAL INVESTIGATION  
6.1 GENERAL  
The clinical investigation is a pre-market, prospective, multicenter, randomized, crossover study in 
adult subjects with ESKD treated with CAPD. 
   
The study consists of the following five phases: 
1. Inclusion phase. 
2. In-clinic treatment phase for dose determination and safety evaluation. 
3. Randomization phase. 
4. Transition to home phase. 
5. Home treatment phase for efficacy and safety evaluation.  
 
Patients need to use the Baxter PD system and have a PD prescription of at least one 2.27% glucose 
day dwell of 1.5-2 L to be included in the study. There is an optional run-in phase during the inclusion 
phase in order for the patient to meet the PD prescription inclusion criteria. Throughout the study, 
the subject will use the fill volume they normally use, both for the standard PD prescription and for 
the Carry Life® UF treatments. However, for the PET a 2 L fill volume will be used.  
 
The in-clinic phase consists of one 2.27% CAPD dwell (PET) and two Carry Life® UF treatments (one at 
11 g/h glucose and one at 15 g/h glucose). The Carry Life® UF treatments will be used for a safety 
evaluation, and based on the UF volumes achieved, the Carry Life® UF glucose dose for the home 
treatment phase will be determined. 
 
After completion of the in-clinic phase, subjects will be randomized to start the home treatment 
phase either with the control treatment arm or with the Carry Life® UF treatment arm. Subjects in 
the control arm will continue their standard CAPD treatment. In the Carry Life® UF arm, one 2.27% 
glucose CAPD dwells per day will at three days of the week be replaced by a Carry Life® UF 
treatment. During the remaining four days of the week, one 2.27% glucose CAPD dwell will be 
replaced with a 1.36% glucose CAPD dwell.  
 
The Carry Life UF system will be used during Mondays, Wednesdays and Fridays, instead of a 2.27% 
glucose dwell. The time of the day when the Carry Life® UF system will be used does not need to be 
at the same the same time of the day as the 2.27% glucose dwell. The time of the day when the Carry 
Life UF system will be used, may differ on different days based on the subject’s schedule.  
 
At four (4) efficacy evaluation days during the home treatment phase (two per arm), there will be a 
careful recording of the solution volumes used (PD solution and glucose solution), volumes drained, 
and samples will be taken from the drain bags after treatment. The subject, together with the 
responsible physician, will determine during which days and during what time of the day the efficacy 
evaluation treatments (the 2.27% glucose dwell during the control arm and the Carry Life® UF 
treatment during the Carry Life® UF arm) will be performed. For each subject all efficacy evaluation 
treatments shall be performed on the same day of the week and on the same time of the day. A 
2.27% glucose dwell will be the comparator dwell during the control arm. In order to perform the 
comparator dwell and the Carry Life UF treatment during at the same time of day, the physician may 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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need to modify the order and duration of the CAPD day dwells during the efficacy evaluation days in 
the control arm home phase of the study.  
 
AEs, SAEs, and Carry Life® UF device malfunctions will be collected throughout the study. A nurse at 
each participating clinic who has undergone education and training necessary for thorough AE 
collection will be responsible for the recording of AEs (i.e., education in good clinical practice [GCP] 
will be required and training with respect to the eCRF for AE reporting). In case of an AE or device 
malfunction in the home treatment phase, the subject will be instructed to immediately contact the 
clinic. Furthermore, the clinic will contact the subject weekly and specifically ask about the 
occurrence of any AE or Carry Life® UF device malfunction. 
 
The patient’s participation will be approximately 12 weeks. The actual time mainly depends on how 
frequent the three in-clinic visits are scheduled, how many training sessions are required, and the 
scheduling of the training visits. The study schedule will include 8 to 13 visits dependent on the 
individual device training requirements. Only the in-clinic visits and the visits during the home 
treatment phase have been assigned a specific visit number: 
1. Inclusion phase – Screening & consent – Visit 1.  
2. In-clinic treatment phase for dose determination efficacy and safety evaluation – Visits 2–4 
(approximately 2 weeks). 
3. Randomization phase – No visit. 
4. Transition to home treatment phase – Visit T1 to T7 (2–7 visits, approximately 1 week). 
5. Home treatment phase for efficacy and safety evaluation – Visit 5 and 6 (8 weeks; 4 weeks in 
the control arm and 4 weeks in the treatment arm). 
The subject will be followed up for one week for new or continuing AEs after the end-of-study visit. 
The follow-up will be in the form of a phone call or a physical meeting as determined by the 
investigator. 
 
There will be at least one day in between treatment during the in-clinic phase of the study. 
Any changes in medications or PD prescriptions will be recorded during the study. If changes to 
diuretic prescription or PD prescription are made, the reason for the change will be documented. If a 
study participant discontinues the study the reason for this will be documented in detail. 
 
A flow diagram of the study design is shown in Figure 1 and Figure 2. Table 1 outlines the schedule of 
activities at each study visit.   
6.2 DESCRIPTION OF CLINICAL INVESTIGATION PHASES  
6.2.1 
Inclusion phase (Visit 1) 
Following approval by the ethics committee and any required competent authority, the subject will 
be screened for study eligibility and a signed informed consent will be obtained.  
 
Once the patient has signed the approved ICF and has met all the inclusion and no exclusion criteria, 
the subject will be considered eligible to be enrolled in the study. 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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If the subject does not meet the PD prescription requirement, the subject may consent to participate 
in the study and to a change of PD prescription in order to meet the requirement. A run-in period of 
at least two weeks with a PD prescription that meets the inclusion criteria will then be performed.  
 
After the run-in period physician will review the eligibility of the patient to continue the study and 
complete the inclusion of the patient (enrolment point) or alternatively exclude the patient from the 
study. The exclusion of the patient will be recorded as a screening failure and will not be further 
followed up in the study. 
 
Patient demographics, medical history, concomitant medications, baseline PD prescription and 
24-hour UF volume will be recorded. A screening log will be maintained at each study site containing 
limited non-identifiable information. 
 
During the inclusion phase the subject will, together with the responsible physician, decide during 
what day of the week and what time of the day the efficacy evaluation treatments will be performed. 
All efficacy evaluation treatments should be performed the same day of the week and the same time 
of the day. In order to perform the 2.27% glucose comparator dwell and the Carry Life® UF treatment 
at the same time of day, the physician may need to modify the order and duration of the CAPD day 
dwells during the efficacy evaluation days in the control arm of the home treatment phase of the 
study.  
6.2.2 
In-clinic treatment phase for dose determination and safety evaluation 
The in-clinic treatment phase will be used to determine the Carry Life® UF dose to be used during the 
home treatment phase and to enable a safety assessment of the Carry Life® UF glucose dose before 
using the Carry Life® UF device at home. The in-clinic treatment phase will consist of one 2.27% 
glucose, 4-hour dwell (PET), and two 5-hour Carry Life® UF treatments (one at 11 g/h glucose and 
one at 15 g/h glucose). The PET may be performed in the patient’s home if the clinic has experience 
of this practice and a procedure for performing PET at home. 
 
The subjects will use their regular PD prescription the night before each visit, and the PD fluid will be 
drained at the clinic in the morning before the start of the study treatment. However, the night 
before the PET, patients who use an icodextrin PD solution overnight will replace the icodextrin 
solution with a 2.27% glucose solution. 
 
There will be at least one day in between the treatments during the in-clinic treatment phase. 
 
The time and type of breakfast before the in-clinic treatments will be recorded. Any food and fluid 
intake, as well as urinary output during the visits will be recorded. The subject will be allowed to have 
a light meal with low glucose content (avoiding sugary carbohydrates) and will only be allowed to 
drink water and beverages without sugar. Diabetic subjects will record the time for diabetic 
medications taken before and during the treatment. 
 
AEs, SAEs, and Carry Life® UF device malfunctions will be recorded. 
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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After each in-clinic treatment, the physician may modify the subject’s PD prescription for the 
reminder of the day according to clinical judgement and standard clinical practice to enable 
adequate fluid removal. 
 
Visit 2 (2.27% glucose PET) 
• 
The day before Visit 2, a 24-hour urine collection will be initiated, unless the patient is anuric 
(<100 ml urine volume/24 hours), and analyzed according to Table 1. 
• 
Patients with an icodextrin prescription for the overnight dwell will replace the icodextrin PD 
solution with a 2.27% glucose PD solution the night before the PET. 
• 
A 4-hour PET with 2 L, 2.27% glucose PD solution will be performed and the dialysate will be 
analyzed according to Table 1.  
• 
Blood samples will be taken before treatment for analysis of study base line blood chemistry 
according to Table 1. 
• 
Venous blood samples for blood glucose measurement will be taken before treatment, at 30 
min, at 1 hour and then hourly until the fourth hour (end of treatment) via a peripheral 
intravenous cannula. If it is not possible to cannulate a subject, samples shall be taken by 
venipuncture before treatment, at 1 hour and 4 hours. 
• 
Body weight, blood pressure and heart rate will be measured before and after the treatment. 
 
Visit 3-4 (Carry Life® UF treatments) 
• 
A 5-hour Carry Life® UF treatments will be performed (Visit 3 using the 11 g/h glucose dose 
and Visit 4 using the 15 g/h glucose dose). 
• 
A 1.36% glucose PD solution, 1.5–2 L according to the subject’s standard prescription will be 
used for the initial fill and automatic drains will be performed hourly, which means that 
approximately 180 ml of dialysate will be removed by the system and transferred into a drain 
bag every hour. The dialysate will be analyzed according to Table 1. 
• 
Venous blood samples for glucose measurement will be taken before treatment, at 30 min, 
at 1 hour and then hourly until the fifth hour (end of the treatment) via a peripheral 
intravenous cannula. If it is not possible to cannulate a subject, samples shall be taken by 
venipuncture before treatment, at 1 hour and 5 hours.  
• 
Body weight, blood pressure and heart rate will be measured before and after the 
treatments. In addition, blood pressure will be measured in case of clinical symptoms 
suggestive of hypotension such as lightheadedness, dizziness, feeling faint, tiredness or 
weakness, change of consciousness e.g., drowsiness, nausea, and cold and clammy skin. 
 
Subjects will be withdrawn from the rest of the study if they: 
 
1. Experience a systolic blood pressure < 100 mmHg where the hypotension is deemed to be 
caused by hypovolemia due to excessive peritoneal UF. 
2. Generate an UF rate higher than 20 ml/kg body weight/treatment. 
 
If the 11 g/h glucose dose Carry Life® UF treatment results in a UF volume of 1.0 L or greater, the 
15 g/h glucose Carry Life® UF treatment will not be performed. 
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
 Page 49 | 97 
 
Based on the UF volume obtained from the Carry Life® UF treatments the Carry Life® UF dose 
prescription for the home treatment phase will be determined according to the following criteria: 
1. The 15 g/h glucose dose will only be used if both of the following conditions are met: 
• 
The treatment with the 11 g/h glucose dose achieved a UF volume of less than 1.0 L.  
• 
The treatment with the 15 g/h glucose dose achieved a UF volume 25% greater than the 
treatment with the 11 g/h glucose dose. 
2. In all other cases the 11 g/h glucose dose will be used. 
 
For example:  
• 
The 11 g/h glucose dose gave a UF volume of 500 ml and 15 g/h glucose dose gave a UF 
volume of 700 ml UF (40% greater than the 11 g/h glucose dose) à the 15 g/h the Carry 
Life® UF glucose dose shall be used. 
• 
The 11 g/h glucose dose gave a UF of 500 ml and 15 g/h dose gave a UF of 620 ml (24% 
greater) à the 11 g/h Carry Life® UF glucose dose shall be used. 
• 
The 11 g/h glucose dose gave a UF volume of 1000 ml à the 11 g/h Carry Life® UF glucose 
dose shall be used. 
 
Before continuing to the randomization phase, the responsible physician will review the blood 
chemistry and blood glucose data generated during the in-clinic treatment phase, as well as and the 
occurrence of a systolic blood pressure of < 100 mmHg or, an UF rate exceeding 20 ml/kg body 
weight/treatment and confirm that the subject can proceed to the next phase of the study.  
 
Identification of efficacy evaluation days: The patient, together with the physician, will confirm the 
scheduling of the four efficacy evaluation days which will take place during week 2 and week 4 of 
each study arm in the home treatment phase. For each patient, the efficacy evaluation days should 
be scheduled on the same day of the week, a Monday, Wednesday or Friday and the same time of 
the day. 
6.2.3 
Randomization phase 
After completing the in-clinic treatment phase, subjects who will be prescribed the Carry Life® UF 
11 g/h glucose dose will be randomized with an equal ratio into Group A (starting with the control 
arm) and Group C (starting with the Carry Life® UF arm).  Subjects who will be prescribed the Carry 
Life® UF 15 g/h glucose dose will be randomized with an equal ratio into Group B (starting with the 
control arm) and Group D (starting with the Carry Life® UF arm) (refer to Figure 1). The 
randomization is being done to reduce any potential for bias based on subjects starting in the 
treatment or control arms. 
6.2.4 
Transition to home phase  
The subjects (and their caregivers, in case the subject has a caregiver who normally performs the PD 
treatment for the subject) will undergo daily training on the Carry Life® UF device, for 2-5 days, to 
ensure that the user can operate the device safely and autonomously. 
 
Before allowing the subject to proceed to the Carry Life® UF home treatment phase, the 
patient/caregiver will be evaluated and has to pass a Carry Life® UF system competency test 
(Attachment A), which has to be signed by the responsible training nurse. Each training session will 
be documented. 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
 Page 50 | 97 
 
 
If the patient/caregiver does not pass the device competency assessment, two additional training 
sessions may be performed and the device competency assessment repeated. If the 
subject/caregiver still does not pass the device competency assessment the subject will be excluded 
from the home treatment phase of the study. The number of subjects who do not pass the device 
competency assessment will be documented and reported. 
 
AEs, SAEs, and Carry Life® UF device malfunctions will be recorded. 
6.2.5 
Home treatment phase for efficacy and safety evaluation 
Subjects randomized to Group A and Group B will start the home treatment phase in the control arm 
with their standard CAPD prescription. Subjects randomized to Group C and Group D will start the 
home treatment phase in the Carry Life® UF treatment arm. After four weeks the subject will 
cross-over to the other arm.  
 
In the control arm subjects will use their regular CAPD prescription. In the Carry Life® UF arm, on 
Mondays, Wednesdays and Fridays, the subject will replace a 2.27% glucose dwells with the Carry 
Life® UF treatments at the determined glucose dose (11 g/h or 15 g/h). Each Carry Life UF treatment 
may be performed at a time of the day that suits the subject. The remaining four days of the week, 
one 2.27% glucose dwell will be replaced by a 1.36% glucose dwell. Both arms of the home treatment 
phase will start the same day of the week, either on a Wednesday or a Friday.  
 
The week prior to starting home treatment with the Carry Life® UF device, subjects will undergo 
training on the device and an assessment of their device competency will be performed, as described 
in Section 6.2.4.  
 
The Carry Life® UF device will be incorporated in the subject’s CAPD regimen as follows: 
• 
The preceding CAPD dwell will be ended with a complete peritoneal drain. 
• 
The Carry Life® UF treatment starts with a fill of 1.36% glucose PD solution, 1.5-2 L, according 
to the subject’s standard CAPD procedure. 
• 
After the fill, the Carry Life® UF device will be connected to the catheter extension set 
according to the IFU, and the Carry Life® UF treatment will be started. 
• 
After five hours the Carry Life® UF treatment will end, the device will be disconnected and 
the peritoneal fluid will be drained. The subjects will then continue with their standard CAPD 
prescription. 
 
A clinical professional will be present for the first Carry Life® UF treatment at home to oversee the 
Carry Life® UF system set-up.  
 
During the home treatment phase of the study, the subject will record body weight, blood pressure 
and heart rate daily in a patient diary (Table 1). Furthermore, the glucose concentration of the PD 
solutions that are used will be recorded daily, together with the PD fill and drain volumes. 
 
Diabetic subjects will monitor and manage their blood glucose levels in accordance with their normal 
practice. After initiating Carry Life® UF treatments, blood glucose levels, measured as part of the 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
 Page 51 | 97 
 
subject’s standard diabetes management, will be evaluated daily by the clinic for at least three days, 
until judged clinically stable. Thereafter, blood glucose levels will be evaluated weekly by the clinic.  
 
At the start of the second and third week of each study arm of the home treatment phase a nurse 
will contact the subject to check on clinical status, AEs, and Carry Life® UF device malfunctions. The 
clinical follow-up will include data on body weight and blood pressure, as well as a clinical 
assessment of volume status and clinical symptoms. These evaluations will also be performed at the 
end-of study arm visits. 
 
Based on the clinical assessments throughout the study, the responsible physician will adjust the 
subject’s PD prescription in order to maintain an adequate fluid balance according to clinical 
judgement and standard clinical practice.  In the control arm, the glucose concentration of the PD 
dwells may be adjusted as required.  
 
If a reduced peritoneal fluid removal is deemed necessary during the Carry Life® UF arm, the change 
in prescription shall be performed in the following order. 
1. Reduce the glucose concentration of the CAPD dwells. 
2. Reduce the frequency of the Carry Life® UF treatments. 
 
When a Carry Life® UF treatment is removed from the prescription, a 2.27% glucose or a 1.36% 
glucose CAPD dwell will replace the Carry Life® UF treatment based on the clinical judgement of the 
responsible physician. 
 
The Carry Life® UF treatment should be performed at least twice per week.  If the subject requires a 
Carry Life® UF treatment frequency fewer than two days per week to avoid hypovolemia, the subject 
will be withdrawn from the study. 
 
If an increased peritoneal fluid removal is deemed necessary during the Carry Life® UF arm, the 
change in prescription shall be performed in the following order: 
1. Re-introduce the 2.27% glucose CAPD dwells that were reduced to 1.36% glucose (one at the 
time at a frequency indicated by the subject’s clinical status). 
2. When all 2.27% glucose dwells have been re-introduced, one additional Carry Life® UF 
treatment will be added weekly until the fluid removal is deemed sufficient. The added Carry 
Life® UF treatment will always replace a 2.27% glucose CAPD dwell.  
 
All changes to the subject´s PD prescription will be documented and the reason for the change 
specified.  
 
The subject should immediately contact the clinic if they have any questions or concerns about their 
clinical status or the study in general. If there are any concerns about the subject’s clinical status that 
cannot be resolved by phone, the subject should always be brought to the clinic for a clinical 
assessment.  
 
The subject will be instructed to record all clinical symptoms (AEs) and all technical issues (device 
malfunctions) with the Carry Life® UF system during the home treatment phase on forms which are 
part of a patient diary and provided to the subject before starting the home treatment phase. The 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
 Page 52 | 97 
 
subject will be instructed to immediately contact the clinic if any clinical symptoms or technical 
issues with the Carry Life® UF system occur. The means of contacting the clinic will be provided.   
 
Efficacy evaluation days: The efficacy evaluation days will be performed during week 2 and week 4 
of each study arm during the home treatment phase, on the day (a Monday, Wednesday or Friday) 
and time of the day agreed. If an immediate change in a subject’s prescription is required, affecting 
the planned efficacy evaluation day, the efficacy evaluation treatment will be postponed 2-3 days. 
Such occurrences will be recorded in the eCRF and indicated in the study report.  
 
During the efficacy evaluation days the dialysate drained from the comparator 2.27% glucose dwell 
(control) and from the Carry Life® UF treatment will be collected by a research assistant for endpoint 
evaluation and analyzed according to Table 1. The 2.27% glucose control dwell will be 5 hours i.e., 
the same duration as the Carry Life® UF treatment.  
 
Visit 5–6 
The day after the completion of each arm (control and Carry Life® UF), the subject will visit the clinic 
for data collection according to Table 1. The Carry Life® UF end-of-arm visit will be performed the day 
after the last Carry Life® UF treatment. The end-of-arm visits should be planned to be performed on 
the same day of the week, e.g., for a subject who started the study arms on a Wednesday, the last 
treatment of the arm will be on a Monday and the end-of-arm visits will be on a Tuesday. Starting 
two days before the end-of-arm visits, a 24-hour urine sample will be collected, unless the subject is 
anuric (< 100 ml urine volume/24 hours), and analyzed according to Table 1. Visit 6 will be the 
completion of the study for the subject. Upon completion of the study, subjects who had their PD 
prescription adjusted to enable entry into the study have the option of returning to their previous 
prescription. 
 
Subjects who prematurely end the study will undergo an end-of-study visit. 
 
6.2.6 
Description of measures to minimize or avoid bias 
The Sponsor will avoid improper influence on any parties participating in, or contributing to, the 
clinical investigation or the induction thereof. The selection and treatment of participants and 
evaluation of clinical investigation data are potential sources of bias. Methods that are incorporated 
within the clinical investigation design to minimize potential bias include, but are not limited to, 
screening participants to confirm eligibility with defined inclusion/exclusion criteria prior to 
enrolment; maintaining a log of all participants screened and enrolled; collecting demographics, 
medical history, and medications at baseline to later assess possible characteristics that may 
influence endpoints; standardizing data collection requirements and clinical investigation 
procedures; using standardized training materials for all study personnel; and by conducting regular 
monitoring visits to verify adherence to the CIP and source data. 
 
As the clinical investigation involves the use of a medical device it is not possible to blind the 
investigational staff or the patients. Randomizing the order of the study arms in this cross-over study 
will minimize the risk that a general disease progress affects the outcome. 
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
 Page 53 | 97 
 
The UF volume result may be biased if the peritoneal drain is performed in different subject positions 
during the drain. During the efficacy evaluation days the subject will be instructed to perform the 
study drains in the sitting position. 
 
The UF volume is determined by the length of the treatment. Both the control dwell and the Carry 
Life® UF dwells during the efficacy evaluation days therefore should be of similar duration. In a 
standard CAPD dwell, maximum UF occurs after around 2 hours after which it slowly decreases as 
there will be a net fluid absorption when the osmotic pressure gets too low.23 The treatment time for 
both the control and the Carry Life® UF treatment is defined as the time between the end of 
peritoneal fill and the start of the peritoneal drain. For the control dwell, the subject will be 
instructed to start the peritoneal drain 5 hours after the end of the peritoneal fill. Both start time and 
end time will be recorded. For the Carry Life® UF There will be a short delay between the end of fill 
and start of treatment of the Carry Life® UF device for connection and priming of the system.  The 
Carry Life® UF treatment automatically stops 5 hours 0/+15 min after the start of treatment. The 
Carry Life® UF treatment therefore is expected to be up to 20 min longer than the control dwell. This 
bias is in favor of the control dwell as a longer control dwell after a 5-hour dwell time would result in 
an equal or lower UF volume. 
 
6.2.7 
Endpoints  
6.2.7.1 
Primary endpoint 
The primary endpoint has been defined to address the primary objective; to demonstrate that Carry 
Life® treatment at home results in an increased UF volume compared to a 2.27% glucose CAPD dwell. 
 
Primary endpoint: 
UF volume during 5-hour treatments at home (Carry Life® UF treatment vs. a 2.27% glucose CAPD 
dwell).  
 
Rationale for the primary endpoint: 
Carry Life® UF has been developed to address inadequate fluid management in PD patients which has 
been associated with increased morbidity, mortality, and technique failure. 
6.2.7.2 
Secondary endpoints 
• 
AE and SAE rates. 
• 
Peritoneal sodium removal. 
• 
Glucose UF efficiency. 
• 
Peak dialysate glucose concentration. 
 
Rationale for the secondary endpoints: 
• 
The Carry Life® UF system should be as safe to use as standard PD methods. 
• 
Higher peritoneal sodium removal has been associated with increased survival.12 
• 
Glucose absorption in PD is associated with metabolic syndrome and increased body weight. 
An increased glucose efficiency means that a required UF volume may be achieved with a 
reduced glucose uptake. 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
 Page 54 | 97 
 
• 
Hypertonic PD solutions are associated with peritoneal membrane deterioration which 
reduces the UF capacity resulting on technique failure. A higher dialysate glucose 
concentration also leads to a higher glucose uptake rate. Carry Life® UF is expected to obtain 
a higher UF volume with a lower dialysate peak glucose concentration. 
6.2.8 
Methods and timing for assessing, recording, and analyzing of variables 
The following clinical tests/assessments will be performed to assess the performance of the Carry 
Life® UF system (Table 7). The timing of the assessments in relation to the study visits is contained in 
Table 1. 
 
Table 7. The tests methods, recording and analysis of variables 
Test/assessment 
Required 
measurements 
Recording 
Analysis 
Source data 
PD fill volume  
Weight of full PD bags 
with or without outer 
wraps. 
Weight of plastic 
material (may be 
predetermined). 
In-clinic visits, PET, 
and Carry Life® UF 
treatments: 
Home phase efficacy 
evaluations 
treatments 
(control 
and Carry Life® UF). 
 
All CAPD dwells and 
Carry Life® UF 
treatments during 
home phase. 
Calculated by electronic 
data capture (EDC):  
The weight of full PD bags 
minus weight of the plastic 
material. 
Work sheets for 
measured data 
and eCRF for 
calculated data. 
Drained volume  
Weight of drain bags. 
Weight of plastic 
material (may be 
predetermined) 
 
Calculated by EDC: 
The sum of all volumes 
drained for each treatment, 
including all dialysate 
sample volumes. 
 
The drained volume in each 
drain bag is calculated as 
the weight of the drain bag 
minus the weight of the 
plastic material. 
 
Work sheets for 
measured data 
and eCRF for 
calculated data. 
Treatment time 
(hours) 
Time for end of 
peritoneal fill and start 
of peritoneal drain.  
Calculated by EDC:  
Time between “end of 
peritoneal fill” and “start of 
peritoneal drain”  
Work sheets for 
measured data 
and eCRF for 
calculated data. 
Glucose 
volumeexact  
Weight of full glucose 
bag with or without 
outer wrap. 
Weight of used glucose 
bag. 
Weight of plastic 
material (may be 
predetermined) 
Carry Life® UF in-
clinic treatments and 
Carry Life® UF 
efficacy evaluation 
treatments (ml). 
Calculated by EDC;  
Weight of full glucose bag 
minus weight of used 
glucose bag (g) divided by 
the density of the 50% 
glucose solution (1.2235 
g/ml). 
Work sheets for 
measured data 
and eCRF for 
calculated data. 
Glucose 
volumeapprox for 
Carry Life® UF 
home treatments 
other than 
efficacy 
evaluation days 
(ml) 
None, nominal volume 
for the 5 hour Carry 
Life® UF treatment at 
each dose 110 ml (11 
g/h) and 150 ml (15 
g/h) is used. 
 
Daily during Carry 
Life® UF arm  
N/A 
 
eCRF (prescribed 
Carry Life UF 
glucose dose). 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
 Page 55 | 97 
 
Test/assessment 
Required 
measurements 
Recording 
Analysis 
Source data 
UF volumeexact 
(ml) 
PD fill volume. 
Glucose volume. 
Drained volume. 
 
In-clinic visits,  
Home phase efficacy 
evaluations 
treatments  
 
Calculated by EDC;  
Drained volume-PD fill 
volume - Glucose 
volumeexact. 
Work sheets for 
measured data 
and eCRF for 
calculated data. 
UF volumeapprox. 
(ml) 
PD fill volume. 
Glucose volume. 
Drained volume. 
All dwells/Carry Life® 
UF treatments during 
home phase. 
Calculated by EDC;  
Drained volume-PD fill 
volume - Glucose 
volumeapprox. 
 
Work 
sheets/electronic 
patient-reported 
outcome 
measures 
(ePROM) for 
measured data 
and eCRF for 
calculated data. 
UF rate  
(ml/kg body 
weight/treatmen
t) 
UF volumeexact. 
Body weight before 
treatment. 
 
In-clinic phase, Carry 
Life® UF treatments. 
 
Calculated by EDC;  
UF volumeexact/Body weight 
before treatment. 
 
Work sheets for 
measured data 
and eCRF for 
calculated data. 
UF volume % 
increase  
UF volumeexact 
End of In-clinic phase 
Calculated by EDC;  
([UF volumeexact Visit4/ UF 
volume exact Visit3]-1)*100 
eCRF 
Dose 
determination 
UF volume % increase 
End of In-clinic phase 
Determined by EDC 
according to dose 
determination algorithm. 
 
 
Dialysate glucose 
concentration  
 
Glucose concentration 
in drain samples 
  
In-clinic phase, PET, 
and Carry Life® UF 
treatments: 
PET:  T0, T1h, T2h, 
T4h 
Carry Life UF: T0, 
T1h, T2h, T3h, T4h, 
T5h, peritoneal drain 
Laboratory analysis 
 
Laboratory data  
Peak dialysate 
glucose 
concentration 
Glucose concentration 
in drain samples 
  
In-clinic phase, Carry 
Life® UF treatments: 
T1h, T2h, T3h, T4h, 
T5h 
Data analysis 
N/A 
PET 
Sodium and creatinine 
concentration in 
dialysate. 
PET, at T0, T1 and T2 
T4 
D/P creatinine  
 
Transfer type determined as 
D/P creatinine at 4h  
Low: 0.34-0.50 
Low average: 0.50-0.65 
High average: 0.65-0.81 
High: 0.81-1.03 
 
Sodium dip: 
Dialysate sodium: T1 minus 
T0 
Laboratory data  

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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Test/assessment 
Required 
measurements 
Recording 
Analysis 
Source data 
Glucose 
absorption 
PD fill volume. 
Glucose volumeexact. 
Drain volumes 
(peritoneal drain + 
Carry life UF drain 
bag). 
Glucose concentration 
of drain volumes 
(peritoneal drain + 
Carry life UF drain 
bag). 
In-clinic 
(Carry 
Life 
UF 
treatments) 
Home phase efficacy 
evaluations 
treatments 
(control 
and Carry Life® UF). 
 
 
Sum of glucose added  
(PD fill volume (ml) * 
glucose concentration of PD 
solution (13.6 or 22.6 g/ml) 
+ Glucose volumeexact (ml) * 
0.5 g/ml) minus the sum of 
glucose drained (peritoneal 
drain volumes * the glucose 
concentration of drain 
volumes (g/ml).   
Work sheets for 
measured data, 
laboratory data 
and eCRF for 
calculated data. 
Fluid intake and 
urine output. 
Fluid intake volume 
and urine volume. 
During the PET and 
Carry Life® UF study 
session. 
For evaluation. 
Worksheets 
Body surface 
area (BSA)(m2) 
Subject height and 
body weight. 
 
V2 before treatment 
(BSA according to Gehan 
 and George =
0.0235Body weight (kg)0.514
Height (cm)0.42246). 
Worksheets for 
measured data 
and eCRF for 
calculated data 
Urine clearance 
24-h urine volume and 
24-h urine sample 
for analysis of 
creatinine and urea.  
Urine collection 
completed prior to 
V2, V5 and V6. 
Calculated by EDC;  
Calculation of creatinine and 
urea clearance and residual 
renal function normalized to 
1.73m2 BSA.  
 
Urinary clearance (ml/min) 
of creatinine and urea is 
calculated using the 
following equation: 
𝐶𝑙=
(𝑈𝑆∙𝑉𝑈)
(𝑃𝑆∙𝑇) *1.73/BSA  
where US is the 
concentration of the 
substance in the 24-hour 
urine sample, VU urine 
volume (ml), PS is the 
concentration in plasma of 
the substance, and T total 
time for urine collection 
(min).  
Worksheets and 
laboratory data  
 
Residual renal 
function 
Urine clearance of 
creatinine and urea 
 
N/A 
Calculated by EDC;  
(Clcreatinine+Clurea)/2 
Worksheets and 
laboratory data, 
eCRF for 
calculated data.  
Laboratory data 
 
Body weight 
change 
 
Body weight. 
Before and after the 
PD exchange in PET 
and Carry Life® UF 
study sessions and 
daily during the 
home phase 
Body weight after minus 
body weight before.  
Worksheet or 
eCRF (in case of 
electronic diary 
use during home 
phase) 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
 Page 57 | 97 
 
Test/assessment 
Required 
measurements 
Recording 
Analysis 
Source data 
Peritoneal 
creatinine and 
urea removal 
Carry Life UF drain 
volume. 
Peritoneal drain 
volume. 
Concentrations of 
creatinine and urea in 
drain volumes. 
In-clinic Carry Life® 
UF study sessions. 
Efficacy evaluation 
treatments during 
home phase. 
 
Data analysis. 
The sum of removal in Carry 
Life® UF drain volume and 
the peritoneal drain.  
 
 
Work sheets and 
Laboratory data 
Blood chemistry: 
Na+, K+, Mg2+, 
ionized Ca2+, 
PO43–, albumin, 
creatinine, urea 
and PTH 
Concentration of 
solutes in blood 
samples. 
At study start (before 
PET visit 2, and at 
end of each arm (V5 
and V6). 
 
Laboratory analysis. 
 
Laboratory data. 
 
 
Peritoneal solute 
removal Na+, K+, 
Ca2+, PO43-, 
albumin, 
creatinine and 
urea 
PD fill volume. 
Concentration of each 
solute in the PD 
solution (known) 
Drain volumes 
(peritoneal drain + 
Carry life UF drain). 
Concentration of each 
solute in drain volumes 
(peritoneal drain + 
Carry life UF drain 
bag). 
 
In-clinic, Carry Life UF 
treatments (V3 and 
V4) and during 
efficacy evaluation 
days during home 
phase  
Data analysis. The 
difference between amount 
added in the PD solution 
(volume * concentration) 
and the sum of the amounts 
removed in drained fluid 
(volumes * concentrations)   
Work sheets for 
measured data 
and eCRF for 
calculated data. 
Laboratory data 
Vital signs 
 
Blood pressure and 
heart rate (HR).  
During visits to the 
clinic (before and 
after treatment).  
Blood pressure and 
heart rate daily by 
patient during home 
phase. 
Monitoring of status and 
changes. 
 
Worksheet or 
eCRF (in case of 
electronic diary 
use during home 
phase). 
 
6.2.9 
Equipment for assessing the clinical investigation variables  
The measurement of the clinical variables in the clinical investigation will be performed with 
equipment used in clinical praxis, such as scales and blood pressure cuffs.  
 
For the measurements performed at the clinic the same scale for PD solutions shall be used for all 
subjects, where possible. If possible, the calibration status of equipment used in-clinic for measuring 
the clinical investigation parameters will be documented at the initiation visit.  
 
During the home treatment phase, subjects will use the same equipment as they normally use for 
their PD treatment (scales, and blood pressure cuff). A subject who does not have the required 
equipment at home will be provided with adequate equipment for the study. All measurements of 
PD bags and drain bags will be performed on desk scales, as hook scales are not deemed to be 
reliable.  
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
 Page 58 | 97 
 
The same body weight scale, PD bag scale and blood pressure cuff will used by each subject for the 
measurements at home to which means that small systematic measuring errors by the equipment 
will not have an impact on the outcome of the study. 
 
Laboratories normally used by the clinics will be performing the laboratory analyses used for this 
clinical investigation. Blood and urine samples will be analyzed by the authorized laboratory at the 
clinical sites. One authorized laboratory will be used for analyses of all dialysate samples. Samples 
collected for laboratory analysis will only be saved for the duration required for the study.   
6.2.10 Investigational device and comparator 
The patient’s exposure to the investigational device occurs during the Carry Life® UF treatments (two 
in the in-clinic treatment phase and approximately 12 during the home treatment phase). Each 
treatment with the device lasts for 5 hours which results in a total device exposure of 70 hours.  
 
Table 8. Carry Life® UF treatments during the clinical investigation 
Carry Life® UF treatments during study 
14 treatments x 5-hour study sessions 
Total = 70 hours  
 
In total approximately 40 devices will be used in this clinical investigation across 6-12 sites. The 
patients will as far as possible use the same device during the clinical investigation. 
 
If a subject finishes the Carry Life® UF arm of the study, the device may be cleaned according to 
Section 10.1.1 “Cleaning with spillage” in the IFU and then used by another subject. No comparator 
devices will be used in the investigation. A 2.27% glucose CAPD dwell will be the comparator. 
6.2.11 Other materials/products required for the clinical investigation 
 
Table 9. Products used in the clinical investigation 
Product 
Procedure 
A permanent PD catheter 
Available in situ and used to perform the subject’s 
standard PD therapy. 
A Baxter MiniCap extended life PD transfer 
set with twist clamp 
The Baxter MiniCap extended life PD transfer set with 
twist clamp is part of the patient’s standard PD treatment.  
Each transfer set is used normally used for several months 
before it is exchanged. 
Standard Baxter 1.36%/1.5%* glucose PD 
solutions  
 
Initial fill prior to starting the Carry Life® UF treatment 
and according to the patient’s standard PD prescription 
during the study. 
Standard Baxter 2.27%/2.5%* glucose PD 
solutions 
Used for the PET treatment (Visit 2) and according to the 
patient’s standard PD prescription during the study. 
50% glucose (500 g per L) solution for infusion 
in the Freeflex bag (Fresenius Kabi) 
Added to the PD solution by the Carry Life® UF system 
during treatments. 
* 1.5% monohydrous glucose (Dianeal) is equivalent to 1.36% anhydrous glucose (Physioneal) and 2.5% 
monohydrous glucose (Dianeal) is equivalent to 2.27% anhydrous glucose (Physioneal). 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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6.2.11.1 Peritoneal dialysis catheter  
A prerequisite for treatment with the Carry Life® UF device is that the patient has a permanent PD 
catheter, as access to the peritoneal cavity is required. Patients recruited to the clinical investigation 
will be stable on PD therapy and have a permanent PD catheter in situ. The type of catheter used by 
the patient is not critical. The Carry Life UF system has been verified using a flow restrictor simulating 
the combined flow resistance of the peritoneal catheter, transfer set and connector in accordance 
with IEC 60601-2-39:2018 (Particular requirements for basic safety and essential performance of 
peritoneal dialysis equipment).    
6.2.11.2 A Baxter MiniCap extended life PD transfer set with twist clamp 
The Carry Life UF system has been verified for use with a Baxter MiniCap extended life PD transfer 
set with twist clamp. The Carry Life UF system was connected to the Baxter MiniCap extended life PD 
transfer set with twist clamp also in the previous clinical investigations. 
6.2.11.3 Baxter 1.36 % (1.5%) glucose PD solution for the Carry Life® UF study sessions 
In the previous clinical investigation Tmed-007, the Carry Life UF system was used with a 1.36% 
glucose Baxter Physioneal PD solution. The justification for the choice of the 1.36 % glucose PD 
solution for the Carry Life® UF treatment is that the use of hypertonic glucose solution should be 
minimized.  When starting with a 1.36% glucose PD solution for the Carry Life® UF treatment, the 
peritoneal membrane will be exposed to lower dialysate glucose concentration than when using a 
2.27% glucose PD solution and the total glucose uptake with the Carry Life® UF treatment will be as 
low as possible.   
 
In this study the subject will use the same Baxter PD solution that they already use for their standard 
PD prescription, Physioneal or Dianeal. Dianeal is not marketed in Sweden, but is available on the UK 
market. The 1.5% monohydruos glucose used in the Dianeal PD solution is equivalent to the 1.36% 
anhydrous glucose used in the Physioneal PD solution.  
 
There are only small differences in the composition of the different PD solutions as seen in the Table 
10 below. The buffer concentration is 35 mM or 40 mM, provided either as a combination of 
bicarbonate and lactate or only lactate. The calcium concentration varies between 1 mM and 
1.75 mM between different solutions based. The lower calcium concentrations are used in order to 
obtain a larger peritoneal calcium removal in patients for whom that is indicated. The small 
difference in the PD solutions has no impact on the treatment with Carry Life UF. 
 
Table 10. The composition of different Baxter low strength glucose PD solutions 
 
Physioneal 35 
Physioneal 40 
Dianeal PD 2 
Dianeal PD 4  
Dianeal  
1 mmol/L 
Calcium 
Glucose anhydrous (%) 
1.36% 
1.36% 
 - 
 - 
 - 
Glucose H2O (%) 
 - 
 - 
1.5%* 
1.5%* 
1,5% 
Sodium (mM) 
132 
132 
132 
132 
132 
Calcium (mM) 
1.75 
1.25 
1.75 
1.25 
1 
Magnesium (mM) 
0.25 
0.25 
0.25 
0.25 
0.25 
Chloride(mM) 
101 
95 
96 
96 
96 
Lactate (mM) 
10 
15 
40 
40 
40 
Bicarbonate (mM) 
25 
25 
 - 
 - 
 - 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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Osmolality (mOs) 
 345 
344 
346 
345 
344 
* 1.5% Glucose monohydrate is equivalent to 1.36% anhydrous glucose. 
 
Subjects will use the same fill volume that they use for their standard CAPD prescription.   
6.2.11.4 A 2.27 % (2.5%) glucose PD solution in  
The subject will use a 2.27% Baxter PD solution according to their CAPD prescription during the study 
but not for the Carry Life® UF treatments. 
6.2.11.5 The 50% glucose solution 
The 50% glucose is a solution for infusion indicated for nutritional purposes and manufactured by 
Fresenius Kabi. The product is marketed in Sweden with authorization number 9590 and has the ATC-
Code B05BA03.  The glucose solution will have an additional label in English and Swedish, including 
the statement FOR CLINICAL TRIAL USE ONLY/ ENDAST FÖR KLINISK PRÖVNING/. 
 
The 50% glucose solution is added during the Carry Life® UF treatment in order to maintain the 
glucose concentration in the dialysate, provided by the initial peritoneal fill of a 1.36% glucose PD 
solution. Glucose is the most commonly used osmotic agent in PD solutions, and the 50% glucose 
solution has the same intended use (peritoneal UF) and mechanism of action, acting as an osmotic 
agent, as the glucose in the PD solution.  The same Fresenius-Kabi 50% glucose solution was used in 
the clinical investigation Tmed-007.  The glucose solution has an interface to the line set and is 
compatible with the glucose spike of the Carry Life® UF line set.  
6.3 SUBJECTS  
6.3.1 
Subject selection  
The patients to be recruited in the clinical investigation have been on stable PD therapy for ESKD for 
at least three months and with a PD prescription of 2-4 CAPD dwells/day, unchanged for a minimum 
of two weeks, with at least one 1.5-2 L 2.27% glucose day dwell daily. 
 
Should a change of the PD prescription be necessary for a subject to be eligible for the study, a run-in 
period of at least two weeks with the modified PD prescription should take place.  The change in 
prescription will be made after assessment by the responsible physician to ensure that the new 
prescription is clinically comparable to the current prescription.  Such a change will require the 
subject to consent to a change of PD prescription on the Patient Informed Consent Form.  
After the run-in period physician will review the eligibility of the patient to continue the study and 
complete the inclusion of the patient (enrolment point) or alternatively exclude the patient from the 
study. The exclusion of the patient will be recorded as a screening failure and the subject will not be 
further followed up in the study. 
 
 
 
 
 If patients treated with PD therapies have regular clinical checkups the Investigator may either 
approach the patient during these visits or by other means. After the patient has signed the ICF they 
are allocated a specific study number, which is used in the investigation documents and consecutive 
number are allocated with continued inclusion at each site.  

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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Approximately 25 patients will be enrolled in this clinical investigation with a goal of 19 completing 
the study per protocol. Patients will be enrolled across six (6) to twelve (12) European sites. 
 
There will be a competitive enrolment without a minimum enrolment for each site. 
 
All patients recruited in the clinical investigation shall be accounted for, including those who 
withdraw from the investigation. The total duration of the patient’s participation is around 12 weeks 
depending upon when it is suitable for the patients to schedule the study visits. The total time for 
recruitment and study completion is estimated to be approximately 12 months (including an 
estimated 9-month enrolment period).  
6.3.1.1 
Inclusion criteria  
1. Age ≥ 18 years. 
2. Subjects with ESKD treated with PD for at least three (3) months. 
3. A PD prescription of 2-4 CAPD dwells/day unchanged for a minimum of two (2) weeks, with 
at least one 1.5-2 L 2.27% glucose day dwell daily. 
4. Subjects must be able to tolerate a 2 L PD fill volume for the PET. 
5. Subjects using the Baxter PD system. 
6. In the opinion of the Investigator, the subject has the capacity to learn how to use the Carry 
Life® UF system or has a caregiver who can do so. 
7. Obtained written consent to participate in the study. 
 
Exclusion criteria 
1. A PD prescription including a regular 3.86% glucose day dwell. 
2. An episode of peritonitis within the last three (3) months. 
3. Serum potassium > 6 mmol/l within the last three (3) months. 
4. Serum urea > 35 mmol/l within the last three (3) months. 
5. Clinical signs of dehydration. 
6. Systolic blood pressure < 100 mmHg within the last month. 
7. Known diagnosis of clinically significant aortic stenosis. 
8. Clinical condition of unstable diabetes. 
9. Subjects with a life expectancy of < 6 months. 
10. Evidence of any other diseases or medical conditions that may interfere with the planned 
treatment or affect participant compliance. 
11. Participation in clinical trials, interfering with the present study, within the previous month. 
12. Anticipated living donor kidney transplantation within six (6) months of screening. 
13. Pregnant, breastfeeding, or women of childbearing potential who are not using an effective 
method of contraception (hormonal contraceptives or barrier contraceptive methods). 
6.3.2 
Criteria and procedures for subject withdrawal or discontinuation 
6.3.2.1 
Withdrawal of subjects from the clinical investigation 
Subjects may withdraw from the clinical investigation for any reason and at any time, without the 
need to justify their decision and without further medical care being penalized. However, the 
Investigator should record the date and reason for the participant’s withdrawal, if possible. The 
Investigator also has the right to withdraw participants at any time if it is in the participant’s best 
interest. Subjects must be withdrawn from the clinical investigation for the following reasons: 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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• 
The patient withdraws consent. 
• 
The patient is unwilling or unable to comply with the CIP. 
• 
Lost to follow-up. 
 
The subject must be permanently removed from the clinical investigation for the following medical 
reasons: 
• 
The occurrence of peritonitis. 
• 
The patient experiences a medical emergency that necessitates permanent discontinuation 
of the investigation.  
• 
At the discretion of the Investigator for medical reasons or for noncompliance. 
 
The reason for the withdrawal must be recorded in the medical records and in the CRF. If a subject is 
withdrawn from the study, an end-of study visit should be performed if possible. Any AE that is 
ongoing when the patient is withdrawn from the investigation shall be followed-up until the AE is 
resolved or the Investigator deems the AE stable and no further follow-up is required. The date when 
the Investigator considers one of these outcomes to have been fulfilled will be considered the last 
visit for the subject, and the outcome shall be recorded in the eCRF. 
 
All data collected prior to the patient’s withdrawal may be used in the analysis of the clinical 
investigation, with the patients consent.  
6.3.2.2 
Withdrawal of subjects from study treatment 
A study treatment must be ended in case of the following reasons:  
• 
The patient experiences a medical emergency that necessitates ending the treatment. 
• 
At the discretion of the Investigator for medical reasons. 
 
The reason for the withdrawal must be recorded in the medical records and in the eCRF and SAEs, 
SADE and USADE. 
6.3.3 
Procedures for replacing subject  
Patients who withdraw or are withdrawn from the clinical investigation will be replaced if the desired 
number of patients has not been achieved. In this case other patients will be approached with regard 
to participation.  
 
Participants who screen-fail may be replaced. 
6.4 PROCEDURES  
A description of the clinical investigation design is contained in Figure 1 and Figure 2. Table 1 details 
the schedule of activities at each visit.  
6.4.1 
Clinical investigation related procedures  
 
Visit 1: Screening and inclusion (-14–0 Days) 
The activities are mainly concerned with the collection of the informed consent and baseline data as 
follows: 
1. Fulfillment of the Inclusion and exclusion criteria (enrolment point).  

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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2. Demographics (year of birth, age, gender, ethnicity, height, and body weight). 
3. Medical history (including, cause of ESKD, year of diagnosis of kidney disease, start of PD, 
start of ESKD therapy other than PD, if applicable, and comorbidities). 
4. Concomitant medications. 
5. Baseline PD prescription (volumes and glucose concentration for the day dwells, volume for 
the icodextrin and volume and glucose concentration for glucose-based night dwell, as 
applicable). 
6. Fluid restriction. 
 
Visits 2-4: In-clinic treatments (Week 1–2) 
The in-clinic treatment visits will consist of: 
1. Recording changes in concomitant medications. 
2. Recording changes in fluid restriction. 
3. Body weight, systolic and diastolic blood pressure, and heart rate will be measured before 
and after treatment. In addition, blood pressure will be measured in case of clinical 
symptoms suggestive of hypotension.   
4. Food intake and fluid intake/urinary output. 
5. Blood samples. 
6. Dialysate samples. 
7. PD bags used (the volume and glucose concentration of PD bags used for the PET and Carry 
Life® UF treatments will be recorded). 
8. Fill and drain volumes (the PD bag and glucose bag will be weighed before treatment and the 
drain bag(s) after treatment for calculations of fill volume, drained volume and UF volume). 
9. A baseline (Visit 2) 24-hour urine sample (urine volume and urine concentration of creatinine 
and urea collected for calculation of residual renal function). 
10. Carry Life® UF safety assessment.  
11. Transition to home evaluation. 
12. AE, SAE, and device malfunction monitoring. 
 
Device training visits (T1–T7; Week 3 Group C, D; Week 7 Group A, B) 
The device training may be performed at the clinic or at the patients home as agreed between the 
clinic and the patient with a device competency assessment at the end of the transition to home 
phase. 
The device training will further consist of: 
1. Recording changes in concomitant medications 
2. Recording changes in fluid restriction 
3. AE, SAE, and device malfunction monitoring. 
 
Home treatment phase (Week 3–6 Group A, B; Week 4–7 Group C, D; and Week 8–11) 
The home treatment phase will consist of: 
1. Recording changes in concomitant medications. 
2. Recording changes in fluid restriction. 
3. Body weight, systolic and diastolic blood pressure and heart rate measurements daily. 
4. PD bags used (subjects will record volume and glucose concentration). 
5. Fill and drain volumes (subjects will record fill and drain weights of all dwells) 
6. 24-hour UF collection (end of arm). 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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7. Subject clinical evaluation (subjects will be contacted weekly for evaluation of body weight, 
blood pressure, volume status and clinical symptom). 
8. AE, SAE, and device malfunction monitoring. 
9. Four efficacy evaluation treatments 2nd and 4th week of each arm with collection of dialysate 
samples and weighing of the solutions bags (PD bag and glucose bag) and the drain bags. 
 
Visit 5 (Week 6 Group A, B; Week 7 Group C, D) 
Visit 5 will consist of: 
1. Recoding changes in concomitant medications. 
2. Recording changes in fluid restriction. 
3. Body weight, systolic and diastolic blood pressure and heart rate measurements. 
4. Blood samples. 
5. 24-hour urine sample, (urine volume and sample). 
6. AE, SAE, and device malfunction monitoring. 
 
Visit 6/End-of-study visit (Week 11/After premature study exit) 
Visit 6 will consist of the following: 
1. Recoding changes in concomitant medications. 
2. Recording changes in fluid restriction. 
3. Body weight, systolic and diastolic blood pressure and heart rate Blood samples. 
4. 24-hour urine sample, (urine volume and sample). 
5. AE, SAE, and device malfunction monitoring. 
6.4.2 
Activities performed by sponsor representatives 
A Triomed representative:  
• 
May be on-site during the initial Carry Life® UF study sessions at the clinic to offer support 
with device related questions, but will not participate in procedures related to the 
investigation. The procedures involved in the clinical investigation will be performed by the 
clinical professionals at each respective site as described in Section 2.7.  
• 
Will train the applicable personnel at each site in the Carry Life UF system. 
• 
May train the patients/caregiver in the Carry Life® UF system (the clinic will be responsible 
for the device competency assessment) 
• 
May oversee the first Carry Life UF treatment at home. 
• 
May weigh solution bags and collect dialysate samples from the drainage bags during the 
efficacy evaluation treatments.  
6.4.3 
Foreseeable factors that may compromise the outcome of the clinical investigation or the 
interpretation of results  
The present study is designed as a controlled, randomized, multicenter, crossover study. The UF 
outcome in PD is dependent on the peritoneal transfer (transport) characteristics. In order to 
evaluate the results based on the subject’s transport characteristic a PET is performed to determine 
the patient’s transport type. To reduce the impact of interpatient variability the study is designed as 
a crossover study where each patient will generate results from both study arm. The difference 
between treatment will be assessed by a paired analysis.  
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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The determined UF is dependent on the actual UF as well as the dialysate volume remaining in the 
peritoneal cavity from the preceding dwell and after the recorded dwell. In order to account for that 
variability, the performance endpoints will be based on the average from two treatments in each 
arm.  
 
In order to determine correct UF during PD it is very important to determine exactly the volume that 
is instilled into and drained from the peritoneal cavity. To ensure that the weighing of the solution 
bags and drain bags is performed correctly, detailed written weighing procedures will be used. 
Furthermore, weighing will be performed by trained study personnel or a Triomed representative 
during the efficacy evaluation treatments.  
 
The study is randomized for in what arm to start the study in order to account for possible disease 
progression, e.g., a decline in RRF over the course of the study.  
6.5 MONITORING  
Qualified monitors representing the sponsor will conduct monitoring activities according to the 
monitoring plan. The Investigator must permit clinical investigation related monitoring by providing 
direct access to source data and to the subject’s medical records, as well as the Investigator Site File 
and storage location of the investigational device. The Sponsor, or its designee, is responsible for 
ensuring that the clinical investigation is adequately monitored. The purpose of monitoring is to 
ensure:  
1. The rights and wellbeing of the subjects. 
2. The clinical investigation data are accurate, complete, and verifiable from source documents. 
3. The clinical investigation is compliant with the CIP, ICH-GCP, ISO 14155:2020 and regulatory 
requirements. 
 
Due to the complexity of the clinical investigation monitoring will be performed on-site before, 
during and after the clinical investigation.   
The activities involved with monitoring consist of: 
1. Site initiation visit. 
2. Routine Monitoring Visits regularly during the clinical investigation, 
3. Close-out visit. 
 
The site initiation visit is performed when all the documentation required to perform the clinical 
investigation have been obtained and compiled in the site investigation file, the study has been 
approved by the Ethics Committee and the Competent Authority and the Clinical Trial Agreement has 
been executed. The main purpose for the Site Initiation Visit is to ensure that the clinical 
investigation is conducted according to the CIP and in accordance with GCP and regulatory 
requirements.  
 
The aspects of the clinical investigation that will be presented is including but not limited to:  
• 
The function of the device and the IFU. 
• 
Overall design for the clinical investigation. 
• 
Presentation of the CIP and eCRF. 
• 
The Initiation of the specific training required as described in Section 2.7. 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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During the clinical investigation the monitor will visit the investigation site at regular intervals as 
defined in the approved monitoring plan and as agreed with sponsor. During these visits the CRF’s 
and supporting documentation related to the clinical investigation will be reviewed and any 
discrepancies or omissions will be resolved.  
 
Reports of the monitoring visits will be submitted to the Sponsor representative for review. The 
monitoring report summarizes the significant findings, deviations, deficiencies, conclusions, and 
actions taken or recommended actions.   
 
The monitoring visits must be conducted according to the appropriate Standard Operating 
Procedures (SOPs) based on ICH-GCP and EN ISO 14155:2020 guidelines to ensure adherence to the 
CIP, the quality of the data, compliance with regulatory requirements and continued adequacy of the 
investigational site and its facilities. Representatives of the Sponsor and/or Regulatory agencies may 
visit the site to perform audits/inspections, including source data verification. The Investigator must 
permit access to source data during auditing and monitoring.  
 
The documents generated for the clinical investigation will be traceable and identifiable by versions 
and corresponding dates. The essential documents for the clinical investigation contained in the ISF 
and TMF shall be securely stored both by the Investigator and the Sponsor.   
 
Further information and details regarding monitoring arrangements can be found in the monitoring 
plan. 
 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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7 STATISTICAL CONSIDERATIONS 
7.1.1 
Sample size  
The primary objective in the present study is to compare the UF volume obtained with the Carry Life® 
UF device, at the glucose dose determined by the UF volume obtained during the in-clinic phase of 
the study, and the UF volume obtained by a standard 2.27% glucose dwell of the same duration 
when performed by the patient at home. Carry Life® UF is intended as an intermittent treatment in 
order to provide an additional removal of fluid in patients whose UF need is not met be their 
standard PD regimen. A UF volume ≥ 250 ml greater with the Carry Life® UF treatment than with the 
2.27% glucose CAPD dwell is considered a clinically relevant UF volume. Assuming three 5-hour 
treatments with Carry Life® UF per week this corresponds to an increase in fluid removal of 
750 ml/week. 
 
The sample size is calculated using the UF volume data from a previous pilot study (Tmed-007) on 
eight subjects, with the aim to demonstrate a superiority margin, delta (δ), of 250 ml. For each 
subject the delta (δ) UF volume between the control 2.27% CAPD dwell and the Carry Life® UF 
treatment (paired comparison) at either the 11 g/h or the 14 g/h glucose dose provided input to the 
sample size calculation. The glucose dose providing input was selected following the dose 
determination scheme described for the current study (refer to page 47). The difference between the 
Carry Life® UF and the control 2.27% CAPD dwell had a mean value of 574 ml and a standard 
deviation of 236 ml.  
 
The sample size is estimated by  
𝑛= 
(𝑧𝛼+ 𝑧𝛽)2𝜎𝑚2
2(𝜖−𝛿)2
 
where 
 = test - control  
 = superiority margin  
m = standard deviation of the paired differences 
 
Set  
Alpha = 0.025, Z_alpha = 1.96 
Power = 0.80, Z_beta = 0.842 
m = 236 
 =  
 =  
 
 
Assuming a standard deviation of 236 ml, an expected difference of 574 ml and a superiority margin 
of 250 ml requires a sample size of 3 to obtain 80% power for the superiority test ( = 0.025) using a 
one sample superiority (one-sided) t-test sample size calculation.  
 
We also consider a more extreme case where we assume a standard deviation of 1.4 times the 
previous standard deviation, or 330 ml. Further, we lower our assumed mean difference to 400 ml 
(about 0.7s below the previous observed value). With these assumptions (standard deviation of 330 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
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ml, an expected difference of 400 ml, and a superiority margin of 250 ml) we require a sample size of 
19 to obtain 80% power for the superiority test ( = 0.025).  
 
The study size of 25 was selected based on the conservative sample size with additional subjects to 
account for possible dropouts.  
7.1.2 
Intent-to-treat and per protocol population 
The intent-to-treat (ITT) population is defined as all the included patients. 
 
Table 11. Definition of intention to treat and per protocol populations 
Endpoint Description 
Intent-to treat (ITT) population 
Per protocol (PP) population 
Primary Endpoint 
Primary endpoint (UF 
volume) 
 
Subjects with data from one or 
more per protocol efficacy 
evaluation treatments in each 
study arm. 
Subjects with two per protocol 
efficacy evaluations treatments 
performed on the planned efficacy 
evaluation day and dwell of the day 
in each study arm. 
Secondary Endpoints 
Safety endpoint (AEs 
and SAEs) 
All the included subjects. 
 
All subjects who complete four 
week´s treatments in each study 
arm during the home treatment 
phase.  
 
Peritoneal sodium 
removal and  
Glucose UF efficiency 
endpoints 
Subjects with data from one or 
more per protocol efficacy 
evaluation treatments in each 
study arm. 
Subjects with two per protocol 
efficacy evaluations treatments 
performed on the planned efficacy 
evaluation day and dwell of the day 
in each study arm. 
Peak dialysate glucose 
concentration* 
 
 
Subjects with in-clinic Carry Life UF 
per protocol treatments with one 
(1) to three (3) glucose dialysate 
results between T1h and T5h per 
glucose dose. 
Subjects with in-clinic Carry Life UF 
treatments dialysate glucose 
samples from at least four (4) time 
points between T1h to T5h. 
 
 
 
7.1.3 
Safety population 
The safety population is defined as all patients receiving at least one treatment with the Carry Life® 
UF system.  
7.1.4 
Per protocol treatments 
Carry Life UF per protocol treatments are Carry Life UF treatments for which the Carry Life UF 
treatment with a treatment time of 5 ± 0.75 hours and a total stop time during treatment of at most 
30 min.  
CAPD per protocol treatments are CAPD treatments with a total treatment time of 5 ± 0.75 hours. 

 
 
 
Study Title:  A clinical study with the Carry Life® UF system in 
continuous ambulatory peritoneal dialysis (CAPD) patients 
Study No.: Tmed-010 
Date: Feb 08 2024 
 
 
 
 
CIP, Tmed-010, Version 6.0 
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7.1.5 
Randomization method 
The randomization will occur after the in-clinic phase of the study, after the glucose dose the subject 
will use in the Carry Life® UF arm has been determined (refer to page 47 for a description of the dose 
determination). The randomization is being done to reduce any potential for bias based on subjects 
starting in the treatment or control arms. For each Carry Life® UF glucose dose (11 g/h and 15 g/h) 
the subjects will be randomized with an equal ratio (1:1) to start with either the control or the Carry 
Life® UF study arm. The randomization is based on block randomization using blocks of four, to 
ensure a balance between those who starts with control and those who starts with the Carry Life® UF 
arm. Subjects using the 11 g/h will be randomized to Group A or Group C. Subjects using the 15 g/h 
will be randomized to Group B or Group D. Group A and Group B will start with control. Group C and 
Group D will start with Carry Life UF. The randomization is a feature of the eCRF and will be manage 
centrally.  
 
7.1.6 
Statistical analysis of primary endpoint 
The primary endpoint uses the UF measured per protocol at each efficacy evaluation treatment 
during the home treatment phase. Each subject is expected to have two efficacy evaluations per 
treatment arm. Subjects with one or more per protocol efficacy evaluations in each arm will be 
included in the primary endpoint analysis. The analysis will be performed for both the ITT and the PP 
population. Excluded subjects will be tabulated with narratives as to why they are missed efficacy 
evaluations.  
 
For each subject, we use the mean UFCL and the mean UFCAPD for analysis. The mean difference (i.e., a 
paired comparison) between the UF achieved with the Carry Life® UF treatment and the UF achieved 
with the control CAPD dwell (UFCL(n) – UFCAPD) will be calculated (UFdiff(n)) with a 95% CI . A 
superiority (one sided t-test) test will be used to demonstrate that the Carry Life UF treatment is 
superior to the control with superiority margin of 250 ml. A superiority margin greater than 0 ml but 
less than 250 ml supports that the Carry Life® UF treatment increases UF as compared to the control, 
but at a level that may not be clinically significant.  
 
For the primary endpoint analysis, the four groups (Group A, 11 g/h starting with control; Group B, 
15 g/h starting with control, Group C, 11 g/h starting with Carry Life UF; Group D, 15 g/h starting with 
Carry Life UF) in the randomization scheme will be pooled.  Control data generated from all four 
groups will be part of the control group and Carry Life UF data for both doses from all four groups 
will be part of the Carry Life UF group. This results in two final groups for primary endpoint analysis; 
control and Carry Life UF. Based on 1) prior pilot study results showing no significant difference 
between the doses and 2) our dose determination procedure, which assigns the glucose dose to be 
used by each subject based on the UF result in the in-clinic phase of the study, we expect the two 
Carry Life UF glucose dose groups to behave as a single population and be poolable for the purposes 
of the primary endpoint of the study. However, as part of our descriptive analysis, we intend to 
summarize the difference in UF volume between study arms for each Carry Life UF glucose dose as 
well as for different fill volumes.   
 
 The treatment performance for the primary objective will also be described based on demographic 
characteristics including age, gender, and ethnicity. 

 
 
 
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7.1.7 
Statistical analysis of secondary endpoint 
For the secondary endpoints no. 2 (peritoneal sodium removal) and no. 3 (glucose UF efficiency), 
each subject is expected to have two efficacy evaluations treatments per study arm. Subjects with 
one or more evaluation treatment in each arm will be included in the secondary endpoint analysis. 
For all secondary endpoints, excluded subjects will be tabulated with narratives as to why they are 
excluded. A subject may be excluded for one or more secondary endpoints, that is, exclusions are 
made independently for each endpoint. 
7.1.7.1 
AE and SAE rates 
All safety events reported during the clinical investigation from either arm during the home 
treatment phase will add information to the safety dataset. Based on all safety data gathered during 
the study for the intent-to-treat (ITT) dataset, AE and SAE occurrences adjudicated to the Carry Life® 
UF treatment or the control treatment will be collected and summarized. The rates of AE and SAE 
and the rates of different types of AE and SAE during the Carry Life® UF treatment arm and during 
the control arm will be presented (events per day). Data for the home treatment phase per protocol 
(PP) data set and the in-clinic treatments will also be gathered and presented. The occurrence of AE 
and SAE for each Carry Life® UF glucose dose will be summarized. 
7.1.7.2 
Peritoneal sodium removal  
Based on data gathered from the efficacy evaluation treatments during the home treatment phase of 
the study, peritoneal sodium removal will be calculated. For each patient the average sodium 
removal from the per protocol efficacy evaluation treatments in each arm will be used for the 
analysis. A paired comparison between sodium removal achieved with the Carry Life treatment 
(NaRevCL) and sodium removal from the control CAPD dwell (NaRevCAPD) will be conducted. The 
average paired difference and the associated 95% CI will be calculated. Further, a t-test will be used 
to demonstrate that the Carry Life® UF treatment has a larger peritoneal sodium removal than the 
control 2.27% CAPD dwell. The analysis will be performed for both the ITT and the PP population.  
The difference in peritoneal sodium removal for each Carry Life® UF glucose dose and each fill 
volume compared to the control CAPD dwell will be summarized.     
 
7.1.7.3 
Glucose ultrafiltration efficiency 
Based on data gathered from the efficacy evaluation treatments during the home treatment phase of 
the study glucose ultrafiltration efficiency will be calculated. For each patient the average glucose UF 
efficiency (ml UF / g glucose absorbed) from the per protocol efficacy evaluation treatments in each 
arm will be used for the analysis. A paired comparison between the glucose UF efficiency achieved 
with the Carry Life® UF treatment (GlucEffCL) and the control CAPD dwell (GlucEffCAPD) per protocol 
treatments will be conducted.  The average paired difference and the associated 95% CI will be 
calculated. Further, a t-test will be used to demonstrate that the Carry Life® UF treatment has a 
higher a glucose ultrafiltration efficiency than the control 2.27% CAPD dwell. The difference in 
glucose UF efficiency for each Carry Life® UF glucose dose and each fill volume compared to the 
control CAPD dwell will be summarized.  
7.1.7.4 
Peak dialysate concentration 
During the in-clinic phase of the study the peak dialysate glucose concentration during the Carry Life® 
UF treatments will be determined from hourly dialysate sampling points, for each glucose dose. For 
this secondary endpoint, each subject is expected to have dialysate glucose data (T1h to T5h) from 
one in-clinic treatment at each Carry Life® UF glucose dose.  

 
 
 
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The average peak glucose dialysate concentration (in %; gram glucose per 100 ml fluid) for each 
glucose dose of the Carry Life® UF in-clinic treatments and the associated 95% CI will be calculated 
for the PP population. Further, a t-test will be used to demonstrate that the peak dialysate glucose 
concentration during the Carry Life® UF treatment is lower than 2.27%. 
 The peak glucose concentration at each fill volume will be summarized.  
7.1.8 
Statistical analysis of exploratory endpoints 
A basic comparison peritoneal removal of creatinine and urea as well as of the weekly UF based on 
patient diary will be performed across the arms of the study.  
7.1.9 
Description and interference  
Aggregated continuous data will be presented in terms of mean, median, standard deviation, 
minimum and maximum, and number of observations. Aggregated categorical data will be presented 
using frequency tables. 
7.1.10 Missing values  
Subjects who drop out of the study will be characterized and compared to those remaining in the 
study based on demographics and co-morbidities. 
7.1.11 Additional summaries 
All demographic and baseline characteristics captured in the CRF will be summarized for all 
populations included in the analysis (ITT and PP as defined for all endpoint analysis see 7.1.1) and 
those that are not, and descriptive statistics will be presented when applicable. The frequency and 
distribution of missing data for any characteristic will also be described. 
7.1.12 Listings 
All data captured in the study will be listed. This will include outcomes not included in the summaries 
such as concomitant medication and medical history.  
 
 

 
 
 
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8 DATA MANAGEMENT 
8.1 PROCEDURES USED FOR DATA REVIEW 
During the site initiation visit, training on the CIP and eCRF will be performed to ensure familiarity 
with the documents and eCRF completion of good quality. Data entries in the eCRF will be monitored 
during the clinical investigation against the source data and verified for accurateness and 
completeness. Data entered to the eCRF are subject to system-implemented edit-checks and 
additional manual checks by data management as per data management plan and data validation 
plan. Any queries generated regarding missing, inconsistent, or illogical data in the eCRF will be 
followed up by the site and verified by the monitor or data management. The eCRF is also reviewed 
for missing data early in the clinical study to reduce systematic data errors, allowing all required data 
to be captured. Any corrections made in the CRF will be tracked by the audit trail and the eCRF is 
signed by the Investigator at completion.  
 
During the clinic visits data may be recorded in the patient file and on source data worksheets before 
entry into the eCRF. Blood and urine samples will be analyzed at the local laboratory used by the site 
and the result entered into the eCRF. For the dialysate samples, the study will use a central 
laboratory that perform all dialysate laboratory analyses. Dialysate data do not need to be analyzed 
until the end of the study and will not be entered into the eCRF. After review of all entered data was 
concluded, all queries have been resolved and all pages have been signed electronically by the 
principal investigators, the eCRF will be locked.   
 
During the home treatment phase subjects will record clinical measurements and solution weights 
daily. Primarily, the subjects will enter the data (e.g., weight and blood pressure) into a mobile 
application. The data entered into the App will be transferred directly into the eCRF and there is no 
additional source documentation expected and thus these values are not subject to source data 
verification through the monitor. In case a subject does not use the App, but records data in a paper-
based diary instead, the data are entered by dedicated site staff into eCRF and are subject for source 
data verification. However, in case of out of limit measurements the site is going to be alerted by 
means of a query and is going to follow-up with the patient to verify and discuss the entered data for 
any potential error. When copies of original source documents as well as printouts of original 
electronic source documents are retained, these shall be signed and dated by a member of the 
investigation site team with a statement that it is a true reproduction of the original source 
document. Copies of the source data shall remain at the clinical investigation site when the 
investigation is completed allowing an independent account of the investigation process.  
  
The data from the eCRF will be managed in an EDC system. The EDC database will be programmed to 
use the input data from the eCRF to calculate output data including the endpoint measures (e.g., UF 
volume, peritoneal removal of the substances analyzed in the dialysate, and glucose efficiency). To 
be able to perform the calculation the following constants will be used: 
• 
Glucose molecular weight: 180.16 g/mol. 
• 
50% glucose solution concentration: 0.5 g/ml. 
• 
Density 50% glucose solution: 1.2235 g/ml. 
 

 
 
 
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Additionally plastic weights of solution bags and drain bags may be pre-weighed and used to 
calculate fill and drain volumes. 
8.2 PROCEDURES FOR VERIFICATION, VALIDATION AND SECURING OF ELECTRONIC DATA 
SYSTEMS 
An EDC system will be used in the clinical investigation. Refer to the data management plan for 
further details. 
8.3 DATA RETENTION AND SPECIFIED PERIOD 
The essential clinical investigation documents shall be stored both by the Investigator and Sponsor. 
The location of the archived documents will be defined and documented for both parties and 
retained for ten (10) years after the completion of the clinical investigation. 
 
 

 
 
 
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9 AMENDMENTS TO THE CIP 
The CIP may require to be amended during the conduct of the clinical investigation. The rationale for 
the amendment must be justified and assessed as to whether it is a substantial or non-substantial 
amendment.24 Amendments regarded as substantial are likely to have a significant impact on: 
• 
The safety or physical or mental integrity of the clinical investigation participants, or, 
• 
The scientific value of the clinical investigation. 
 
Changes in previously approved documents are initiated by Triomed and agreed upon between the 
Sponsor and the Principal Investigator. Substantial amendments are submitted to the competent 
authorities and changes are implemented when approval is obtained. The clinical investigation 
documentation is updated as required and the CIP amendment log (ISF) signed by the Investigator.   
Triomed may at any time amend the CIP to eliminate immediate hazards to subjects. In this case the 
competent authority will be notified subsequently of the modifications.  
 
 

 
 
 
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10 DEVIATIONS FROM CLINICAL INVESTIGATION PLAN 
The Investigator shall conduct the clinical investigation according to and in compliance with the CIP 
agreed to by Triomed and approved by the competent authorities (CA). A deviation from the CIP, is a 
failure to comply with the information specified in the CIP.   
 
The Investigator shall: 
• 
Not implement any deviation from or change the CIP without prior agreement by the 
Sponsor or documented approval from the regulatory authority(ies) of an 
amendment, except where necessary to eliminate an immediate hazard(s) to 
participating patients. 
• 
Promptly notify the Sponsor and document the reasons for the deviation and if 
appropriate proposed protocol amendment(s) to allow expedite reporting to the 
regulatory authority(ies). 
 
During the clinical investigation the monitor will document and report deviations from the CIP, GCP 
and applicable regulations which will be reported to Triomed. The report should include a summary 
of what the monitor reviewed as described in Section 6.5. Accidental protocol deviations can happen 
at any time and must be adequately documented and reported to the Sponsor immediately. 
Frequently recurring deviations will require immediate action and could potentially be classified as a 
serious breach. 
 
With finding of noncompliance to the CIP which significantly affect the patients and the scientific 
integrity of the clinical investigation, a root cause analysis will be performed, and appropriate 
corrective and preventive action taken. The Investigator will be informed in writing by Triomed of the 
corrective actions to be taken to avoid the reoccurrence of deviations and the corrective actions will 
be followed-up. If the Investigator/institution is persistently noncompliance despite corrective action 
by Triomed the Investigators participation in the clinical investigation will terminate. The termination 
of the clinical investigation due to noncompliance will be reported to the competent authorities by 
Triomed.  
 
 

 
 
 
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11 DEVICE ACCOUNTABILITY 
 
The Carry Life UF system including the cycler, line set, carrying bag, storage bag, glucose solution, 
battery, battery charger and PD belt will only be used in the clinical investigation. The Sponsor and 
the Principal Investigator will keep records documenting the shipment (to and from the 
investigational site) and the location of all investigational devices and accessories beginning from 
shipment of investigational devices to the investigation sites until their return to Triomed or 
destruction, as applicable. The Principal Investigator will keep records documenting the hand-over or 
return of all investigational devices and accessories to/from the patient. This will be documented in 
the device accountability log which is contained in both the TMF and ISF and will be updated 
throughout the clinical investigation.  
 
The device accountability log will include information on:  
• 
The date of receipt and the quantities. 
• 
Identification of each investigational device and accessory (batch number or serial number). 
• 
Date on which the investigational device or accessory was returned and the date of return of 
unused, expired or malfunctioning investigational devices, and date of return of unused 
glucose solution. 
 
The serial/batch numbers of the device, the line sets, and glucose solution, and the dates of use will 
also be documented in the patient specific eCRF page. The equipment required for the clinical 
investigation will be stored in a secure area at the participating sites according to the storing 
conditions as outlined in the respective IFUs. The monitor will verify the accountability process at 
each site during the site monitoring visits and at the close-out visit. 
 
 
 
 

 
 
 
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12 STATEMENTS OF COMPLIANCE 
12.1 ETHICAL PRINCIPLES 
To ensure the quality and integrity of research, this clinical investigation will be conducted according 
to the CIP, principles of ISO 14155:2020, EU medical device regulation (MDR) 2017/745, UK MDR 
2002, the Declaration of Helsinki and its amendments, and any applicable national guidelines. 
 
This study must be approved by the relevant competent authority and independent ethics committee 
(IEC) prior to enrolling participants into the study. 
 
Any additional requirements imposed by the IEC or regulatory authority shall be followed, as 
appropriate.  
 
Where applicable and consistent with local regulations and prior to consenting and enrolment of 
participant, the CIP, CIP amendments, Informed Consent Form (ICF), Investigator’s Brochure, and 
other relevant documents must be submitted to an IEC and reviewed and approved by the IEC before 
the investigation is initiated. Any additional requirements imposed by the IEC or regulatory authority 
shall be followed, if appropriate. Consenting and enrolment  of any patient will not start before 
written confirmation of approval from the relevant central or local IEC. All parties involved in the 
conduct of the clinical investigation shall share the responsibility for its ethical conduct in accordance 
with their respective roles. 
12.2 INTERNATIONAL STANDARDS 
The investigation will be performed in accordance with international standards and any regional or 
national regulations, as appropriate. Any additional requirements imposed by the IEC or regulatory 
authority shall be followed, if appropriate. The Carry Life® UF system complies with identified 
applicable regulatory standards, according to Appendix D in the IB. 
12.3 START OF CLINICAL INVESTIGATION 
Before the start of the clinical investigation, approval will be sought from the IEC and regulatory 
authority(ies) with regard to the CIP, IB, informed consent forms and other appropriate documents. 
Approval in writing by an IEC and regulatory authority(ies) shall be received before consenting and 
enrolment of any patient into the investigation. Substantial protocol amendments will be submitted 
by the Sponsor for review and approval by the regulatory authority(ies), and premature termination 
and the reasons for the decision to the regulatory authority(ies) and IEC.  
12.4 ADDITIONAL REQUIREMENT BY EU OR REGULATORY AUTHORITY  
All additional requirement imposed by EU or regulatory authorities shall be followed.  
12.5 INSURANCE 
Sponsor will maintain appropriate clinical study insurance coverage as required under applicable 
laws and regulations for the duration of the clinical investigation. 
 

 
 
 
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12.6 FINANCING  
This clinical investigation will be financed by Triomed AB. 
 
Investigators will provide the Sponsor with sufficient and accurate financial information as requested 
to allow the Sponsor to submit complete and accurate financial certification or disclosure statements 
to the appropriate regulatory authorities. Investigators are responsible for providing information on 
financial interests during the study and after completion of the study according to national 
regulations. All Investigators will be required to meet the requirements of applicable EU/UK 
regulation. Financial disclosures will be collected from all Investigators prior to their participation in 
the investigation. 
 
The financial agreement between the Sponsor and the investigation sites/Investigators are addressed 
in a separate agreement. 
 
All expenses arising in connection with the investigation, the remuneration of the Investigators for 
performance of the investigation, and the indemnification of the participants for their participation 
will be reimbursed in accordance with the respective contracts. 
 
 

 
 
 
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13 INFORMED CONSENT PROCESS 
Prior to performing any clinical investigation activities, including screening tests and assessments, 
written informed consent will be obtained from subjects by signing the approved informed consent 
form.  
 
During the informed consent process the Investigator shall: 
1. Provide the background of the clinical investigation, the procedures involved, the risks and 
benefits and that participation is voluntary. Information shall be provided both verbally and 
in written form.  
2. The patient must be given sufficient time for questions and to consider whether to 
participate in the clinical investigation. 
3. It is the Investigators responsibility to ensure that the patient has understood the purpose of 
the clinical investigation before the ICF is signed. 
4. A copy of the signed and dated consent form will be given to the patient, and participation 
shall be documented in the medical records. 
5. The patient must be informed that they have the right to withdraw their consent at any time, 
without the need for justification and that future medical care will not be jeopardized  
6. If the patient prematurely withdraws from the clinical investigation, make all reasonable 
effort to ascertain the reason. 
4. During the clinical investigation the Investigator shall inform the patients in writing of new 
information that can significantly affect the patient’s future health or medical care. In this 
case the patient has the right to re-evaluate their decision to participate, and a revised 
patient information and informed consent will be signed by both the Investigator and 
patient. 
5. Provide adequate medical care for the participants during and after the investigation, in the 
event of adverse events and medical emergencies (Section 14.1). 
6. The ICF will be retained in the ISF. 
13.1 PATIENT CONFIDENTIALITY 
Participant confidentiality and privacy are strictly held in trust by the participating Investigators, their 
staff, and the Sponsor. All health data collection is conducted in a manner compliant with General 
Data Protection Regulation (GDPR) in the European Union (EU) and applicable data privacy law. 
Therefore, the CIP, documentation, data, and all other information generated will be held in strict 
confidence. No information concerning the study, or the data will be released to any unauthorized 
third party without prior written approval of the Sponsor. 
 
Confidentiality of data shall be observed by all parties involved in the clinical investigation at all 
times. All data shall be secured against unauthorized access and in general by: 
• 
The patient’s identification being depersonalized using a clinical investigation coded number. 
• 
The data transferred to the Sponsor shall be in coded form. 
• 
The privacy of the participants and confidentiality regarding information shall be preserved in 
reports and published data. 

 
 
 
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• 
The Principal Investigator will however provide direct access to source data during and after 
the clinical investigation for monitoring, audits, EC review and regulatory authority 
inspections.  
 
The informed consent will also specify that collected data may be transferred (to either EEA 
countries and/or non-EEA countries). In accordance with the EU Data Protection Directive 
(95/46/EC), the data will not identify any patients taking part in the clinical investigation. 
 
 

 
 
 
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14 SAFETY  
14.1 PATIENT SAFETY ASSESSMENTS DURING THE CARRY LIFE® UF STUDY SESSIONS  
Foreseeable adverse events and anticipated adverse device effects are associated with excessive UF, 
increased IP volumes and abnormalities in plasma glucose and electrolytes and a complete 
description of the anticipated device effects and their mitigations can be found in Section 4.3.   
14.1.1 Excessive UF volumes  
During the Carry Life® UF study sessions, it is expected that greater UF rates will be achieved 
compared to standard PD regimes. A maximum total UF volume of ≥ 20 ml/kg body 
weight/treatment has therefore been set for the Carry Life® UF study sessions.  
14.1.2 Clinical evaluation 
Clinical symptoms indicative of fluid depletion due to excessive UF volumes shall be assessed during 
the in-clinic Carry Life® UF treatments. The blood pressure and heart rate are to be monitored before 
and after treatment and when clinically indicated. 
If the systolic blood pressure is <100 mmHg during the Carry Life® UF treatments the patient will be 
excluded from the study. 
The patient will also be excluded from the rest of the study if the Carry Life® UF rate is >20 ml/kg 
body weight/treatment. 
It is at the discretion of the Investigator to discontinue the study session if or when they see fit. The 
Investigator shall treat the clinical symptoms which occur during the study sessions according to 
clinical praxis. The subject’s clinical condition will be evaluated and documented in the CRF after the 
Carry Life® UF study session.  
14.1.3 Increased IP volumes  
Increased IP volumes is mitigated by the automatic hourly drains during the Carry Life® UF 
treatments and optional additional if the patient has symptoms related increased IP volumes.    
14.1.4 Abnormalities in the plasma glucose and electrolyte 
Patient with CKD have abnormal creatinine, urea, and electrolyte values such as potassium, despite 
adequate treatment for CKD. The results of the blood samples cannot be evaluated using normal 
values and ranges and will therefore be assessed and corrected by the Investigator according to 
clinical praxis. The P-glucose will also be assessed and corrected according to clinical praxis (diabetic 
patients).  Baseline blood data will be taken during the 2nd visit and blood glucose will be taken 
regularly during the in-clinic visits. The baseline blood chemistry and blood glucose data during the 
treatment will be reviewed by the physician before allowing the subject to continue to the home 
phase of the study.  
14.2 SAFETY DEFINITIONS 
Throughout the course of the clinical investigation, vigilance must be maintained with regard to 
possible AEs and in the event of their occurrence the first concern is for the safety and well-being of 
the subjects.  
 

 
 
 
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When the ICF is signed, each subject must be informed and receive the names and telephone 
numbers of clinical investigation site staff for reporting AE’s and medical emergencies.  
 
Adverse events will be categorized according to EN ISO 14155:2020, Annex F, MDCG 2020-10/1 
and/or national regulatory requirements. 
14.2.1 Adverse Event (AE) 
An adverse event is any untoward medical occurrence, unintended disease or injury, or any 
untoward clinical signs (including an abnormal laboratory finding) in subjects, users, or other persons 
whether or not related to the investigational medical device. 
  
NOTE 1: This definition includes events related to the investigational device or the comparator.  
NOTE 2: This definition includes events related to the procedures involved.  
NOTE 3: For users or other persons, this definition is restricted to events related to investigational 
medical devices. 
14.2.2 Serious Adverse Events (SAE) 
A serious adverse event is defined according to the following: 
1. Death, 
2. Serious deterioration in the health of the subject, users, or other persons as defined by one 
or more of the following: 
- a life-threatening illness or injury, or 
- a permanent impairment of a body structure or a body function including chronic diseases, 
or 
- in-patient or prolonged hospitalization, or 
- medical or surgical intervention to prevent life-threatening illness or injury, or permanent 
impairment to a body structure or a body function, 
3. Fetal distress, fetal death, a congenital abnormality, or birth defect including physical or 
mental impairment. 
 
NOTE 1: Planned hospitalization for pre-existing condition, or a procedure required by the CIP, 
without a serious deterioration in health, is not considered a serious adverse event. 
14.2.3 Device deficiencies 
The definition of a device deficiency is an inadequacy of a medical device related to its identity, 
quality, durability, usability, reliability, safety, or performance. This may include malfunctions, use 
error, or inadequacy in the information supplied by the manufacturer including labelling.  
14.2.4 Device deficiency with SADE potential  
Device deficiencies that did not lead to an AE but could have led to a Serious Adverse Device Effect 
(SADE) if: 
• 
suitable action had not been taken,  
• 
if intervention had not been made, or  
• 
if the circumstances had been less fortunate. 

 
 
 
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14.2.5 Adverse device effect (ADE) 
An adverse device effect is an adverse event related to the use of an investigational medical device. 
 
NOTE 1: This includes any adverse event resulting from insufficiencies or inadequacies in the 
instructions for use, the deployment, the implantation, the installation, the operation, or any 
malfunction of the investigational medical device. 
NOTE 2: This includes any event that is a result from a use error or intentional abnormal use of the 
investigational medical device. 
14.2.6 Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event. 
14.2.7 Unanticipated Serious Adverse Device Effect (USADE) 
Serious adverse device effect which by its nature, incidence, severity, or outcome has not been 
identified in the current version of the risk analysis report.  
 
NOTE: Anticipated SADE (ASADE): an effect which by its nature, incidence, severity, or outcome has 
been previously identified in the risk analysis. 
14.3 REPORTING OF SAFETY EVENTS 
Investigators must report to the Sponsor, or its designee, all reportable safety events (SAE, Device 
Deficiencies with SAE potential, etc.) via the EDC system, immediately, but not later than three (3) 
days of first awareness. 
 
For all reportable events which indicate an imminent risk of death, serious injury, or serious illness 
and that requires prompt remedial action for other patients/subjects, users or other persons or a 
new finding to it, the Sponsor must report to the National Competent Authority (NCA) immediately, 
but not later two (2) calendar days after awareness of a new reportable event or of new information 
in relation with an already reportable event. 
 
Any other reportable events or a new finding/update to it, must be reported by the Sponsor to the 
National CA immediately, but not later than seven (7) calendar days following the date of awareness 
by the Sponsor of the new reportable event or of new information in relation with an already 
reported event. 
 
Refer to the below sections for further details. 
14.4 IDENTIFICATION, RECORDING AND REPORTING ADVERSE EVENTS 
14.4.1 Recording adverse events  
The site must record every AE and observed device deficiencies (DD), together with a severity and 
causality assessment in the subject’s medical notes and in the eCRF.  
 

 
 
 
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The collection of AEs and DDs can be achieved through discussion with the participant during visits, 
through review of the participant’s medical records or via information obtained from relatives or 
other clinicians or support departments involved in the participant’s care. 
 
Documentation includes dates of event, treatment, resolution, assessment of seriousness, 
expectedness, causal relationship to device and/or clinical investigation procedure (cf. 14.7 – 
Assessments of adverse events). 
 
The clinical course of each event shall be followed until resolution or stabilization. Any AE that is 
ongoing when the patient is withdrawn from the investigation shall be followed-up until the AE is 
resolved or the Clinical Investigator deems the AE stable and no further follow-up is required. The 
date when the Clinical Investigator considers one of these outcomes to have been fulfilled will be 
considered the last visit for the subject, and the outcome shall be recorded in the eCRF. 
14.4.2 Safety monitoring  
The Investigator is responsible for the identification of any AE and DD including SAE/SADE and USADE 
and their report to the Sponsor and designee via the eCRF. 
 
The information may be transmitted verbally initially, but this information must be followed up with 
detailed written reports in the SAE/SADE form contained in the ISF. Written reports must be completed 
legibly, and include all relevant dates and descriptions required by the SAE/SADE form. The Investigator 
must review and sign all SAE/SADE reports.  However, if the Investigator is not available at the time of 
completion of the initial SAE/SADE report then the site should not delay sending the initial report in 
order to comply with the regulatory timelines (listed below). If only limited data are initially available, 
a follow-up report is required. If new information including outcome becomes available, the follow-up 
information has to be documented. 
 
Foreseeable adverse events and anticipated adverse device effects including their possible mitigation 
are contained in Section 4.3  
   
Timelines: 
Any AE/SAE/SADE that occur after the subject has been enrolled until study completion/ termination 
must be reported to the Sponsor immediately, but not later than 3 calendar days after 
investigational staff become aware of the event. All DDs involving any device component must be 
reported within 24 hours of staff become aware of the event to Triomed and the medical device 
handled according to Section 14.3.  
 
Particular attention shall be given to the causality evaluation of USADE events. The occurrence of 
unanticipated serious adverse events related to the use of the device (USADE) could suggest that the 
clinical investigation places subjects at increased risk of harm than was to be expected beforehand. 
All USADE must be reported to the Sponsor regardless of severity within 24 hours.  
 

 
 
 
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Table 12. Reporting information for SAE and SADE 
Reporting Information for SAEs and DDs with SADE potential 
Any Serious Adverse Events that occur between subject enrolment and the end of clinical investigation must 
be reported to the Sponsor or designee immediately, but not later than 3 calendar days after 
investigational staff become aware of the event.  
EMERGENCY CONTACT DETAILS 
AE reporting contact information hereafter may be used in lieu of reporting through the eCRF, 
should the system be down: 
carrylifeUF@iqvia.com 
 
To report initial or follow-up information on a Serious Event,  
Fax or email a complete SAE/SADE or a DD form to the following: Monitor/Sponsor 
 
The initial report shall contain at minimum: 
• 
Patient identification (M/F). 
• 
Age of patient at time of onset. 
• 
Time and date of medical event. 
• 
SAE/SADE classification. 
• 
Description of the event. 
• 
Specific treatment/action. 
• 
Device model and serial 
number.  
• 
Event Status.  
• 
Severity. 
• 
Relationship procedure (causality). 
• 
Relationship investigational device (causality). 
• 
Event outcome. 
The Sponsor must receive a completed SAE/DD Form within 3 calendar days of the occurrence. 
Please use the form for “Serious Adverse Event (SAE)” and “Device Deficiency (DD)” as needed. 
14.4.3 Isolation of the investigational device 
The IFU provided with the Carry Life UF system describes how to identity and troubleshoot the alarm 
conditions. The patient will be instructed to contact the dialysis clinic if they need additional support. 
If the contact person at the clinic is not available, the patient may contact Triomed for technical 
support. The patients can always end treatment according to the instructions in the IFU.  
 
If an alarm cannot be resolved by the patient, the cycler will be assessed by the clinic with support 
from Triomed. If the cycler is deemed functional the cycler will be returned to the patient. If the 
cycler issue cannot be solved, the patient will get a replacement cycler for the remaining duration of 
the study and the non-functional cycler will be returned to Triomed for further assessment. 
 
Triomed technical support can be reached at the following phone number: +46(0)706560444. 
 
If an DD causes an ADE that is defined as serious (SADE) or a DD that could have potentially led to a 
SADE (expected or unexpected) the Investigator must following the below procedures: 
• 
Isolate the device as soon as possible; The device should not be discarded or repaired. The 
device shall be returned to the manufacturer. Detailed instructions on the return procedure 
will be provided by the sponsor to the investigator upon receipt of a DD notification. 
• 
All material evidence i.e., parts removed, replaced, or withdrawn from use following an 
incident including relevant instructions, records and packaging materials or any other means 
of batch identification must be: 
o Clearly identified and labelled. 

 
 
 
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o Stored securely. 
• 
Evidence should not be interfered with in any way, except for safety reasons or to prevent 
loss. Where relevant, a record of all readings, settings, positions of switches, valves, dials, 
gauges and indicators, along with any photographic evidence and eyewitness reports should 
be retained. 
14.5 INVESTIGATORS REPORTING RESPONSIBILITIES 
The Investigator’s responsibilities regarding reporting of AE/ADE are as follows: 
1. Record and monitor all safety events (AEs/SAEs/SADEs/USADEs) including DDs and DDs with 
SADE potential, regardless of the severity or relationship to clinical investigation treatment. 
2. Ensure that safety events reported by the subject and/or caregiver, observed by the 
Investigator, or documented in medical records are also recorded on the adverse event eCRF, 
whether believed to be related or unrelated to the investigational device or procedure. 
3. Determine the seriousness, severity, device and procedure relationship of each event. 
4. Determine the onset and resolution date of each event. 
5. Complete the eCRF as much as possible immediately, but no later than 3 calendar days. 
6. Follow-up information must be actively pursued and the Sponsor informed immediately but 
not later than 3 calendar days. 
7. All device deficiencies must be reported in the eCRF within 24 hours upon knowledge to 
Triomed. 
8. Ensure all AE and SAE/SADE/USADE reports are supported by documentation in the patient’s 
medical records. 
14.6 SPONSORS REPORTING RESPONSIBILITIES 
Triomed/Monitor responsibilities regarding the reporting of reportable events as described in 
Section 14.6.1 to the relevant National Competent Authorities and Ethics Committees are as follows: 
 
1. Review the Investigator’s assessment of:  
1.1 All AEs and determine and document in writing their seriousness, severity, and 
relationship to the investigational device;  
1.2 Review all device deficiencies and determine and document in writing whether they 
could have led to a SADE; 
1.3 In case of disagreement between the Sponsor and the Principal Investigator(s) on the 
above, the Sponsor shall communicate both opinions to concerned parties. 
2. Ensure the reporting to the CAs/ECs of all serious adverse events and device deficiencies that 
could have led to a serious adverse device effect, if required by national regulations or by the 
CAs/ECs.  
3. For all reportable events where there is an imminent risk of death, serious injury, or serious 
illness, that requires prompt remedial action to safeguard other patients or users or, 
4. The identification of new finding must be reported immediately, but no later than 2 calendar 
days after awareness by Sponsor of a new reportable event or of new information in relation 
to already reported events (reportable event section). 
5. Any other reportable events as outlined in Section 14.3 or new finding/update to it must be 
reported immediately, but no later than 7 calendar days after the date of awareness by the 
Sponsor. 

 
 
 
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6. Triomed or designee will report events according to in the MDCG 2020-10/1 rev1 guidelines 
via the MDCG 2020-10/2 reporting form that can be found here. 
7. In case of serious adverse device effects and device deficiencies that could have led to serious 
adverse device effects, determine whether corrective or preventive action is required.  
 
Where necessary to ensure timely reporting, the Sponsor (or designee) may submit an initial report 
that is incomplete followed up by a complete report as soon as additional information becomes 
available. 
14.6.1 Reportable events to Competent Authorities (CAs) and Ethic committees (ECs)  
The following events are considered reportable to the competent authorities in accordance with the 
MDR requirements (Regulation (EU) 2017/745), and the MDCG 2020-10 Guidance on safety reporting 
in clinical investigations shall be followed: 
1. Any SAE that has a causal relationship with the investigational device, the comparator or the 
investigation procedure or where such causal relationship is reasonably possible. 
2. Any device deficiency that might have led to a SAE if: 
• 
Suitable action had not been taken or, 
• 
Intervention had not been made or, 
• 
If circumstances had been less fortunate. 
3. New findings/updates in relation to already reported events in 1) and 2).  
14.7 ASSESSMENTS OF ADVERSE EVENTS  
14.7.1 Severity assessment  
An assessment of severity is required to determine if an event is at a severity not usually seen (i.e., 
that it is unanticipated). The Investigator should assess the severity for each AE according to the 
following criteria (Table 13). 
 
Table 13. Assessment of severity 
Severity of Event 
Mild 
 
The AE does not interfere in a significant manner with the patient’s normal functioning 
level. It may be an annoyance. 
 
Moderate 
 
The AE produces some impairment of function but not hazardous to health. It is 
uncomfortable and/or an embarrassment. 
 
Severe 
 
The AE produces significant impairment of functioning or incapacitation and/or it is a 
hazard to the patient. 
14.7.1.1 Serious health threat 
A serious health threat refers to a signal from any adverse event or device deficiency that indicates 
an imminent risk of death or a serious deterioration in the health in subjects, users or other persons, 
and that requires prompt remedial action for other subjects, users or other persons. 
 
This would include events that are of significant and unexpected nature such that they become 
alarming as a potential serious health hazard or possibility of multiple deaths occurring at short 
intervals. 

 
 
 
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14.7.1.2 Expected assessment 
For all Adverse Device Effects (ADEs), the risk analysis in the CIP will be used by the Investigator as a 
basis for identifying anticipated/unanticipated ADEs characterized by their nature, incidence, 
severity, and outcome. The Investigator must document the version of the IB used on the SAE form 
and/or the DD if applicable. 
 
The assessment of the anticipated nature of the event is important to determine the submission 
timelines of a reportable case.  
 
ADEs will be reported by ticking the “yes” box for ADEs on the eCRF page for AEs/ADEs.  
The procedures described for AEs above will be followed for documenting ADEs.  
14.7.2 Causality assessments  
The relationship between the use of the investigational medical device (including the 
medical/surgical procedure) and the occurrence of each AE shall be assessed and categorized. During 
causality assessment activity, clinical judgement shall be used and the relevant documents, such as 
the IB, the CIP or the risk analysis report shall be consulted, as all the foreseeable SAEs and the 
potential risks are listed and assessed there. The presence of confounding factors, such as 
concomitant medication/treatment, the natural history of the underlying disease, other current 
illness or risk factors shall also be considered.   
 
The assessment of the causality assessment of the event is important to determine the regulatory 
timelines and the reportability of a case to the relevant CAs/ECs.  
 
The Sponsor and Investigator will distinguish between the SAE related to the investigational device 
and those related to the procedures (any procedures specific to the clinical investigation). An AE can 
be related both to procedures and the investigational device.  
 
Complications caused by concomitant treatments are considered not related, as well as routine 
procedures if the said procedure would have been applied to the patients also in the absence of the 
investigational device use/application (standard of care).  
 
Each SAE should be classified according to four different levels of causality. The Sponsor and 
Investigator will use the following definitions to assess the relationship of the SAE to the 
investigational device or procedure according to the following table (Table 14). 
 
Table 14. Assessment of causality 
Not Related 
Relationship to the device, comparator or procedures can be excluded when:  
- the event has no temporal relationship with the use of the investigational device, or 
the procedures related to application of the investigational device; 
- the serious adverse event does not follow a known response pattern to the medical 
device (if the response pattern is previously known) and is biologically implausible;  
- the discontinuation of medical device application or the reduction of the level of 
activation/exposure  
- when clinically feasible  
- and reintroduction of its use (or increase of the level of activation/exposure), do not 
impact on the serious adverse event;  

 
 
 
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- the event involves a body-site or an organ that cannot be affected by the device or 
procedure;  
- the serious adverse event can be attributed to another cause (e.g. an underlying or 
concurrent illness/ clinical condition, an effect of another device, drug, treatment or 
other risk factors);  
- the event does not depend on a false result given by the investigational device used for 
diagnosis, when applicable;  
In order to establish the non-relatedness, not all the criteria listed above might be met at 
the same time, depending on the type of device/procedures and the serious adverse 
event. 
Possible 
The relationship with the use of the investigational device or comparator, or the 
relationship with procedures, is weak but cannot be ruled out completely. Alternative 
causes are also possible (e.g., an underlying or concurrent illness/ clinical condition 
or/and an effect of another device, drug or treatment). Cases where relatedness cannot 
be assessed, or no information has been obtained should also be classified as possible. 
Probable 
The relationship with the use of the investigational device or comparator, or the 
relationship with procedures, seems relevant and/or the event cannot be reasonably 
explained by another cause. 
Causal 
relationship 
The serious adverse event is associated with the investigational device, comparator or 
with procedures beyond reasonable doubt when:  
- the event is a known side effect of the product category the device belongs to or of 
similar devices and procedures;  
- the event has a temporal relationship with investigational device use/application or 
procedures;  
- the event involves a body-site or organ that  
     o the investigational device or procedures are applied to;  
     o the investigational device or procedures have an effect on;  
- the serious adverse event follows a known response pattern to the medical device (if 
the response pattern is previously known);  
- the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious adverse event (when clinically feasible);  
- other possible causes (e.g. an underlying or concurrent illness/ clinical condition or/and 
an effect of another device, drug or treatment) have been adequately ruled out;  
- harm to the subject is due to error in use;  
- the event depends on a false result given by the investigational device used for 
diagnosis, when applicable;  
In order to establish the relatedness, not all the criteria listed above might be met at the 
same time, depending on the type of device/ procedures and the serious adverse event 
 
 

 
 
 
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15 VULNERABLE POPULATION  
The clinical investigation will not involve the inclusion of vulnerable populations unable to give 
consent freely.  
 
 

 
 
 
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16 SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL 
INVESTIGATION 
16.1 END OF THE CLINICAL INVESTIGATION 
The definition of the end of the clinical investigation is the last patient last visit.  
16.2 SUSPENSION OF THE CLINICAL INVESTIGATION 
Triomed may suspend or prematurely terminate the clinical investigation at the investigation site for 
significant and documented reasons. The Principal Investigator, EC, or regulatory authority may also 
suspend or prematurely terminate the participation of the investigational site for which they are 
responsible. 
 
Conditions that warrant suspension or premature termination include but are not limited to:  
• 
The suspicion of an unacceptable risk to the patients.  
• 
New data regarding the risks/benefits of the therapy. 
• 
Serious or repeated deviations by the Investigator of the CIP or GCP. 
• 
When instructed by the EC or regulatory authorities. 
 
NOTE: an earlier end of the clinical investigation, which is not based on grounds of safety, but on 
other grounds, such as faster recruitment than anticipated, is not considered as premature 
termination. 
 
If suspicion of an unacceptable risk to subjects arises during the clinical investigation, Triomed shall 
suspend the clinical investigation while the risk is assessed. Triomed shall terminate the clinical 
investigation if an unacceptable risk is confirmed.  
 
If suspension or premature termination occurs Triomed shall inform the responsible regulatory 
authorities within 15 days of the date of termination by submitting a ‘Declaration of the End of a 
Clinical Trial’. The Principal Investigator and Sponsor shall keep each other informed of any 
communication received from either the EC or the regulatory authority. 
 
NOTE: The usual lines of communication are Sponsor <-> Principal Investigator or Sponsor <-> EC, 
and Sponsor <-> regulatory authority. 
NOTE: The timing and method of this communication will depend upon the circumstances and 
perceived risks. 
 
With early termination Triomed shall remain responsible for providing resources to fulfil the 
obligations of the CIP and existing agreements for the follow-up of enrolled patients. Routine 
close-out activities shall be conducted to ensure that: 
• 
The Principal Investigator's records are complete. 
• 
All documents needed for the Sponsor's files are retrieved. 
• 
The remaining clinical investigation materials are disposed of. 
• 
Previously identified issues have been resolved and all parties are notified. 

 
 
 
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Triomed will also ensure that regulatory authorities are notified as applicable. The Principal 
Investigator shall promptly inform the enrolled patients of the suspension or premature termination 
of the clinical investigation if appropriate. 
16.3 PROCEDURE FOR RESUMING THE CLINICAL INVESTIGATION AFTER TEMPORARY 
SUSPENSION 
When the Sponsor concludes an analysis of the reason(s) for the suspension, implements the 
necessary corrective actions, and decides to lift the temporary suspension, Triomed shall inform the 
Principal Investigators, the ECs, and the regulatory authority of the rationale and provide them with 
the relevant data supporting this decision. 
 
NOTE: The usual lines of communication are Sponsor <-> Principal Investigator or Sponsor <-> EC, 
and Sponsor <-> regulatory authority. 
 
Concurrence shall be obtained from the IECs and regulatory authorities before the clinical 
investigation resumes. If subjects have been informed of the suspension, the Principal Investigator 
shall inform them of the reasons for resumption. 
 
 

 
 
 
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17 PUBLICATION POLICY 
The results of the clinical investigation will be documented in the Clinical Investigation Report (CIR), 
which will also be the case if the investigation is prematurely terminated. The report will be prepared 
by Triomed according to Annex D of ISO 14155:2020 and the Declaration of Helsinki and reviewed 
and signed by the Sponsor and Investigator’s designated as signatory.  
 
The results of the investigation may be submitted for publication, and publications and 
presentations. Triomed also has the right to use the clinical investigation results for registration and 
internal presentations and promotion. With publications of the results the EudraCT number will be 
used, demonstrating that the requirements of the international committee for medical journal 
editors (ICMJE) have been meet.  
 
The clinical investigation will be registered in a publicly accessible database in accordance with the 
Declaration of Helsinki. Triomed will supply written information of the clinical investigation results to 
the Investigator, which will be distributed to the patients who participated.    
 
For further information concerning publication please refer to the “Clinical Study and Investigation 
Agreement” in the ISF.  
 
 

 
 
 
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18 BIBLIOGRAPHY 
 
1. 
Hill NR, Fatoba ST, Oke JL, et al. Global Prevalence of Chronic Kidney Disease - A Systematic 
Review and Meta-Analysis. PLoS One. 2016;11(7):e0158765. 
2. 
Chaudhary K. Peritoneal Dialysis Drop-out: Causes and Prevention Strategies. Int J Nephrol. 
2011;2011:434608. 
3. 
Kwan BC, Szeto CC, Chow KM, et al. Bioimpedance spectroscopy for the detection of fluid 
overload in Chinese peritoneal dialysis patients. Perit Dial Int. 2014;34(4):409-416. 
4. 
Boudville N, de Moraes TP. 2005 Guidelines on targets for solute and fluid removal in adults 
being treated with chronic peritoneal dialysis: 2019 Update of the literature and revision of 
recommendations. Perit Dial Int. 2020;40(3):254-260. 
5. 
Van Biesen W, Williams JD, Covic AC, et al. Fluid status in peritoneal dialysis patients: the 
European Body Composition Monitoring (EuroBCM) study cohort. PLoS One. 
2011;6(2):e17148. 
6. 
Teitelbaum I. Ultrafiltration failure in peritoneal dialysis: a pathophysiologic approach. Blood 
Purif. 2015;39(1-3):70-73. 
7. 
Shu Y, Liu J, Zeng X, et al. The Effect of Overhydration on Mortality and Technique Failure 
Among Peritoneal Dialysis Patients: A Systematic Review and Meta-Analysis. Blood Purif. 
2018;46(4):350-358. 
8. 
Davies SJ. Longitudinal relationship between solute transport and ultrafiltration capacity in 
peritoneal dialysis patients. Kidney Int. 2004;66(6):2437-2445. 
9. 
Daugirdas J B, Ing T. Handbook of Dialysis 5th Edition 2014. Wolters Kluwer. Chapter 26 by 
Boudville N and Blake P. . 
10. 
Gokal R, Moberly J, Lindholm B, Mujais S. Metabolic and laboratory effects of icodextrin. 
Kidney Int Suppl. 2002(81):S62-71. 
11. 
Woodrow G, Fan SL, Reid C, Denning J, Pyrah AN. Renal Association Clinical Practice 
Guideline on peritoneal dialysis in adults and children. BMC Nephrol. 2017;18(1):333. 
12. 
Ateş K, Nergizoğlu G, Keven K, et al. Effect of fluid and sodium removal on mortality in 
peritoneal dialysis patients. Kidney Int. 2001;60(2):767-776. 
13. 
Brown EA, Davies SJ, Rutherford P, et al. Survival of functionally anuric patients on 
automated peritoneal dialysis: the European APD Outcome Study. J Am Soc Nephrol. 
2003;14(11):2948-2957. 
14. 
Jansen MA, Termorshuizen F, Korevaar JC, Dekker FW, Boeschoten E, Krediet RT. Predictors 
of survival in anuric peritoneal dialysis patients. Kidney Int. 2005;68(3):1199-1205. 
15. 
Lin X, Lin A, Ni Z, et al. Daily peritoneal ultrafiltration predicts patient and technique survival 
in anuric peritoneal dialysis patients. Nephrol Dial Transplant. 2010;25(7):2322-2327. 
16. 
Dombros N, Dratwa M, Feriani M, et al. European best practice guidelines for peritoneal 
dialysis. 7 Adequacy of peritoneal dialysis. Nephrol Dial Transplant. 2005;20 Suppl 9:ix24-
ix27. 
17. 
Burkart J. Metabolic consequences of peritoneal dialysis. Semin Dial. 2004;17(6):498-504. 
18. 
Holmes CJ. Glucotoxicity in peritoneal dialysis--solutions for the solution! Adv Chronic Kidney 
Dis. 2007;14(3):269-278. 
19. 
Ortega O, Gallar P, Carreño A, et al. Peritoneal sodium mass removal in continuous 
ambulatory peritoneal dialysis and automated peritoneal dialysis: influence on blood 
pressure control. Am J Nephrol. 2001;21(3):189-193. 
20. 
Rodríguez-Carmona A, Fontán MP. Sodium removal in patients undergoing CAPD and 
automated peritoneal dialysis. Perit Dial Int. 2002;22(6):705-713. 
21. 
Freida P, Issad B. Continuous flow peritoneal dialysis: assessment of fluid and solute removal 
in a high-flow model of "fresh dialysate single pass". Perit Dial Int. 2003;23(4):348-355. 

 
 
 
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22. 
Pérez-Díaz V, Pérez-Escudero A, Sanz-Ballesteros S, et al. A New Method to Increase 
Ultrafiltration in Peritoneal Dialysis: Steady Concentration Peritoneal Dialysis. Perit Dial Int. 
2016;36(5):555-561. 
23. 
Heimbürger O, Waniewski J, Werynski A, Lindholm B. A quantitative description of solute and 
fluid transport during peritoneal dialysis. Kidney Int. 1992;41(5):1320-1332. 
24. 
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-
10/2010_c82_01/2010_c82_01_en.pdf. [Online]  
 
 
 
 
                                                                                                                                                                                                                   

 
 
 
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19  SIGNED AGREEMENT OF THE CLINICAL INVESTIGATION PLAN 
 
I have read the CIP “A clinical study with the Carry Life® UF system in continuous ambulatory 
peritoneal dialysis (CAPD) patients” (Study No.: Tmed-010; Version: 6.0; Date: Feb 08 2024) and 
agree to conduct the clinical investigation according to the CIP and the applicable ICH guidelines and 
GCP regulations and to inform all who assist in the conduct of this study of their responsibilities and 
obligations. 
 
 
 
Sponsors Representative’s Signature  
(Clinical Manager) 
Date 
Sponsors Representative’s Name (Print) 
 
Investigator’s Signature 
Date 
Investigator’s Name (Print) 
 
Study Site (Print) 
 

 
 
 
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20 ATTACHMENTS 
20.1 ATTACHMENT A. PRINCIPAL INVESTIGATOR, COORDINATING INVESTIGATOR AND 
INVESTIGATION SITE(S) 
20.2 ATTACHMENT B. CHECKLIST FOR ASSESSMENT OF CARRY LIFE® UF USER COMPETENCY 
20.3 ATTACHMENT C.  SETTING THE CARRY LIFE® UF GLUCOSE DOSE 
20.4 ATTACHMENT D. THE PET PROCEDURE (VISIT 2) 
20.5 ATTACHMENT E. WEIGHING AND SAMPLING PROCEDURE, VISITS 3 AND 4  
20.6 ATTACHMENT F. WEIGHING AND SAMPLING PROCEDURE DURING THE EFFICACY 
EVALUATION TREATMENTS OF THE HOME PHASE