Performance Evaluation of the AMIA Automated Peritoneal Dialysis (APD) Solution Generation System in Patients Using the AMIA APD Cycler
Phase: NA
Conditions: End Stage Renal Disease (ESRD)
Sponsor: Vantive Health LLC



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Table of Contents
SYNOPSIS..........................................................................................................................7
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ..............................12
1. INTRODUCTION........................................................................................................14
1.1 Background ............................................................................................................14
1.2 Benefits and Risks for the Study Population.......................................................17
1.3 Study Sponsor ........................................................................................................18
2. STUDY OBJECTIVES................................................................................................19
2.1 Primary Objectives................................................................................................19
2.2 Secondary Objectives ............................................................................................19
3. INVESTIGATIONAL PLAN .....................................................................................19
3.1 Overall Study Design and Plan.............................................................................19
3.2 Study Endpoints.....................................................................................................20
3.2.1 Primary Endpoints .........................................................................................20
3.2.2 Secondary Endpoints......................................................................................21
3.3 Rationale for Study Design and Control Group .................................................21
3.4 Study Duration and Dates.....................................................................................22
3.5 Study Intervention Discontinuation and Patient 
Discontinuation/Withdrawal.................................................................................22
3.5.1 Removal of Patients from Therapy, Assessment, or Study.........................22
3.5.2 Discontinuation of the Study..........................................................................24
4. STUDY POPULATION SELECTION......................................................................24
4.1 Study Population....................................................................................................24
4.2 Inclusion Criteria...................................................................................................24
4.3 Exclusion Criteria..................................................................................................26
4.4 Home Assessment and Installation.......................................................................27
4.5 Recruitment............................................................................................................27
5. STUDY TREATMENT(S) ..........................................................................................28
5.1 Description of Treatment(s)..................................................................................28
5.1.1 Study Product: AMIA APD Solution Generation System ..........................28
5.2 Enrollment, Randomization, and Assignment to Treatment Group ................30
5.3 Treatment Duration and Study Visits..................................................................30
5.4 Selection and Timing for Each Patient ................................................................31
5.4.1 Care Partner....................................................................................................32

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5.5 Method of Assigning Patients to Treatment Groups..........................................32
5.6 Blinding...................................................................................................................33
5.7 Concomitant Therapy............................................................................................33
5.8 Prohibitions and Restrictions ...............................................................................33
5.9 Treatment Compliance..........................................................................................33
5.10 Packaging and Labeling......................................................................................34
5.11 Accessibility and Control of Study Participant Data .......................................34
5.12 Storage and Accountability.................................................................................35
5.13 Investigational Product Retention......................................................................36
6. STUDY PROCEDURES .............................................................................................36
6.1 Informed Consent ..................................................................................................36
6.2 Medical History......................................................................................................37
6.3 Physical Examination ............................................................................................37
6.4 Vital Signs...............................................................................................................37
6.5 Clinical Laboratory Tests .....................................................................................37
6.5.1 Laboratory Parameters..................................................................................37
6.5.2 Blood collection ...............................................................................................38
6.5.3 24-Hour Urine Collection...............................................................................39
6.5.4 Peritoneal Kt/Vurea, Renal Kt/Vurea and Total Kt/Vurea ...............................39
6.5.5 White Cell Count and Cell Culture...............................................................39
6.5.6 Sample Collection, Storage, and Shipping ...................................................40
6.5.7 Simulated Treatments ....................................................................................40
6.5.8 Water and Dialysate Sampling Analysis.......................................................40
6.5.8.1 Chemical Contaminants..........................................................................41
6.5.8.2 Microbiological Cultures and Endotoxin – Product Water and 
Water from Holding Bag.........................................................................41
6.5.8.3 Dialysate Composition Testing...............................................................42
6.5.8.4 Additional Sampling Procedures ...........................................................42
6.5.8.5 Process for Responding to Out-of-Specification Results......................42
6.5.8.6 Chlorine and Conductivity Testing........................................................43
6.6 Power Outage .........................................................................................................44
6.7 Boil Water Advisory Procedure ...........................................................................44
6.8 Removal of Patients from the Study ....................................................................44
6.9 Other Study Procedures........................................................................................45
6.10 Appropriateness of Measurements.....................................................................45
7. DATA COLLECTION FOR SAFETY ASSESSMENTS AND REPORTING .....45
7.1 Definition of Adverse Events and Device Deficiencies .......................................45
7.2 Safety Reporting ....................................................................................................47
7.2.1 Adverse Event of Special Interest .................................................................50
7.2.2 Medical Events Commonly Associated with Peritoneal Dialysis ...............51
7.2.3 Adverse Events Reporting .............................................................................51
7.3 Product Complaints...............................................................................................51

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7.4 Medical Monitor ....................................................................................................52
7.5 Safety Reporting to Authorities and Institutional Review Board.....................52
7.6 Pregnancy Reporting.............................................................................................52
8. STUDY ACTIVITIES .................................................................................................52
8.1 Schedule of Evaluations and Procedures.............................................................52
8.2 Screening Period (approximately 3 weeks) .........................................................53
8.3 Training for PD Home Solution Generation System..........................................54
8.4 Baseline Period (In-center Training Period).......................................................54
8.5 Each Treatment Day..............................................................................................55
8.6 Simulated Treatment Visit 1 (Before 1st Treatment in the Home, Study 
Visit 1).....................................................................................................................56
8.7 Study Visits 2, 3 and 4 (Study Treatment Weeks 4, 8 and 12)...........................57
8.8 Total Kt/Vurea Visit.................................................................................................57
8.9 Follow-up Period....................................................................................................58
8.10 End of Study Visit or Early Termination Procedures......................................58
9. DATA MANAGEMENT, QUALITY CONTROL AND QUALITY 
ASSURANCE...............................................................................................................59
9.1 Auditing ..................................................................................................................59
9.2 Non-compliance with the Protocol .......................................................................59
10. PLANNED STATISTICAL METHODS.................................................................60
10.1 General Considerations.......................................................................................60
10.2 Determination of Sample Size.............................................................................60
10.3 Analysis Populations............................................................................................60
10.4 Demographics and Baseline Characteristics.....................................................60
10.5 Primary Analysis..................................................................................................61
10.6 Secondary Analysis..............................................................................................61
10.7 Sensitivity Analysis ..............................................................................................62
10.8 Interim Analysis...................................................................................................62
11. ADMINISTRATIVE CONSIDERATIONS............................................................62
11.1 Investigators and Study Administrative Structure...........................................62
11.2 Institutional Review Board Approval................................................................62
11.3 Food and Drug Administration ..........................................................................63
11.4 Ethical Conduct of the Study..............................................................................63
11.5 Patient Information and Consent.......................................................................64
11.6 Patient Confidentiality ........................................................................................64
11.6.1 Health Insurance Portability and Accountability Act Authorization 
Procedures.......................................................................................................64
11.7 Study Monitoring.................................................................................................65

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11.8 Case Report Forms and Study Records.............................................................65
11.9 Access to Source Documentation........................................................................65
11.10 Data Generation and Analysis..........................................................................66
11.11 Retention of Data ...............................................................................................66
11.12 Financial Disclosure...........................................................................................67
11.13 Publication and Disclosure Policy ....................................................................67
12. REFERENCE LIST...................................................................................................68
List of In-Text Tables
Table 1. Composition of Dextrose Concentrate ............................................................16
Table 2. Composition of Electrolyte Concentrate.........................................................16
Table 3. Composition of the AMIA APD Generated Solution (mmol/L)....................17
Table 4. List of Laboratory Testsa..................................................................................38
Table 5. Adverse Event Term Definition.......................................................................45
Table 6. Definition of Terms ...........................................................................................47
Table 7. Causality Assessments ......................................................................................49
Table 8. Severity Assessments.........................................................................................50
Table 9. Outcome Conclusion Criteria ..........................................................................50
List of In-Text Figures
Figure 1. General Arrangement of the AMIA APD Solution Generation System.....15
Figure 2. Overview of Study Assessments .....................................................................20
List of Appendices
Appendix 1 Schedule of Events.......................................................................................69
Appendix 2 Schedule of Clinical Laboratory Evaluations...........................................75
Appendix 3 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 
Formulations ............................................................................................................77
Appendix 4 Formulas ......................................................................................................78
Appendix 5 Definitions of Adverse Events of Special Interest Terms ........................79
Appendix 6 Medical Events Commonly Associated with Peritoneal Dialysis............80
Appendix 7 New York Heart Association Functional Classification ..........................81
Appendix 8 Sponsor Signatures......................................................................................82
Appendix 9 Investigator’s Signature..............................................................................84

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SYNOPSIS
Name of Finished Product:
AMIA Automated Peritoneal Dialysis (APD) Solution Generation System
AMIA APD Generated Solution
Name of Active Ingredient:
Dextrose Concentrate
Electrolyte Concentrate
Investigational Product:
AMIA APD Solution Generation System
Indication:
End stage renal disease (ESRD) requiring peritoneal dialysis (PD).
Study Title:
Performance evaluation of the AMIA APD Solution Generation System in patients using the AMIA 
APD Cycler.
Study Number:
BXU011787
Primary Objective:
Efficacy:
To evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA 
APD Solution Generation System during simulated treatment, compared to the specifications of Baxter’s 
approved Dianeal Low Calcium (2.5 mEq/L) PD Solution.
Safety:
To evaluate the product water from the Water Device (WD [pre-sterilizing filters]) as meeting ISO 
standard 139591 for microbiological (including endotoxin) and chemical contamination, and water in the 
holding bag (post-sterilizing filters) as meeting system microbiological requirements, when produced in 
patients’ homes using the AMIA APD Solution Generation System, during a simulated treatment.
Secondary Objectives:
•
To evaluate the safety of the AMIA APD Solution Generation System, used to treat patients with 
ESRD, by collecting adverse events (AEs), serious adverse events (SAEs), adverse device effects
(ADEs), serious adverse device effects (SADEs), incidence of device alarms and vital signs.
•
To assess PD adequacy by calculation of total Kt/Vurea.
Overall Study Design and Plan:
This is an open-label, single arm, prospective, descriptive study. Up to 50 PD patients, who are stable on 
in-home APD using the AMIA or HomeChoice APD Cycler, will be enrolled in this study such that a 
total target of 30 evaluable patients complete the 12-week Study Treatment Period and the Follow-up 
Period.
During the Screening Period, all consenting patients will have a home assessment, including feed (tap) 
water analysis, to confirm their home environment is suitable for this study. Eligible patients will be 
followed for data collection regarding dialysate solution composition and safety, while using the AMIA 
APD Solution Generation System.
Data will be collected throughout the duration of the study (approximately 18 weeks), including the 
Screening Period, Baseline Period (In-center Training Period), Study Treatment Period, Follow-up 
Period and the End-of-Study Visit/ Early Termination Visit. All AEs (not reported as medical history), 
product complaints (PCs) and device deficiencies (DDs) observed by the study personnel or reported by 

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the patient during the course of the study will be documented from the time of signing the informed 
consent form (ICF) through the End-of-Study/ Early Termination Visit. The Principal Investigator (PI) 
or designee (e.g., sub-investigator) will assess each patient at the Screening Visit and on a weekly basis,
according to standard of care. At a minimum, this assessment will include evaluation of blood pressure 
(BP), pulse rate, weight, fluid status and dialysis prescription.
Laboratory data will be collected at Screening and during the use of the AMIA APD Solution Generation 
System.
Study Population:
The study population consists of patients with ESRD treated with PD using the AMIA APD Solution 
Generation System. Up to 50 patients receiving a regimen of PD with the AMIA or HomeChoice APD 
Cycler for at least 12 weeks will be enrolled in this study such that a total target of 30 evaluable patients 
complete the 12-week Study Treatment Period and the Follow-up Period.
Inclusion Criteria:
Each patient must meet ALL of the following criteria to be enrolled in this study:
1.
Patient is 18 years or older.
2.
Patient with ESRD receiving PD, and who is already trained and regularly using the AMIA or
HomeChoice APD Cycler with Dianeal PD Solution for at least 12 weeks.
3.
Patient is receiving or willing and able to use Dianeal Low Calcium (2.5 mEq/L) PD prescriptive 
regimen at study treatment initiation per Investigator’s assessment.
4.
Patient demonstrates adequate PD therapy with clinical euvolemia as assessed by the Investigator 
with a total Kt/Vurea of a minimum of 1.7 within 45 days of Screening.2 If a total Kt/Vurea is not 
available within 45 days of Screening, it will be measured at Screening.
5.
Investigator assesses that, with appropriate training, the patient will be able to successfully 
manage his/her dialysis treatments with the AMIA APD Solution Generation System.
6.
Patient is available and is willing to complete training on the AMIA APD Solution Generation 
System.
7.
Patient and home environment are deemed suitable for treatment with the AMIA APD Solution 
Generation System, while in the home.
8.
Home electrical and water assessments meet suitability criteria for the AMIA APD Solution 
Generation System.
9.
The patient’s home has suitable wireless connection or patient is willing to allow installation of 
suitable wireless connection.
10. Patient and/or care partner (if participating, see Section 5.4.1) is able to read and understand 
English, and provide informed consent after an explanation of the proposed study. If the patient 
does not read and understand English, patient may still participate if he/she has a co-residing care 
partner who reads and understands English, assessed as adequate by the PI.
11. Women of childbearing potential (not menopausal or surgically sterile) must not be pregnant. 
Serum qualitative and quantitative pregnancy test will be done within 14 days prior to initiation of 
study product. 
•
If qualitative serum β-hCG results are positive, repeat quantitative serum pregnancy test 
within 48 hours.
•
If quantitative serum β-hCG levels show clinically significant rise within 48 hours, serum 
progesterone level should be taken. Serum progesterone > 5 ng/mL will exclude a patient 
from the study.
12. Sexually active males and females agree to use a reliable means of contraception during the study 
and for 30 days afterwards (e.g., oral contraceptive and condom, intrauterine device and condom, 
or diaphragm with spermicide and condom).

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Exclusion Criteria:
Patient who meets ANY of the following criteria will be excluded from the study:
1.
Patient with a history of PD catheter dysfunction within 12 weeks prior to study enrollment, as 
evaluated by the Investigator.
2.
Patient who had episodes of peritonitis or exit site infection within 12 weeks prior to study 
enrollment.
3.
Patient who has signs of impending or current infection including a cloudy dialysis effluent or 
dialysis white cell count > 100/µL or > 0.1 x 109/L (after a dwell time of at least 2 hours), with 
> 50% polymorphonuclear cells, and/or positive dialysis effluent culture.
4.
Patient who has a severe primary immunodeficiency disorder or other condition that may mask 
clinical signs of peritonitis, as evaluated by the Investigator.
5.
Patient with a history of repeated non-compliance with PD therapy (e.g., a substantial number of 
missed clinic visits, missed treatments or a history of mismanagement of diet or medications), as 
evaluated by the Investigator.
6.
Patient who has acute renal failure with the chance for recovery.
7.
Patient who is pre-scheduled for a living donor kidney transplant within the next 6 months.
8.
Patient who is not expected to live at least 6 months while maintaining PD treatment.
9.
Patient who had major abdominal surgery within 6 months prior to study enrollment.
10. Patient with current abdominal hernia, as evaluated by the Investigator.
11. Patient with advanced liver or pulmonary disease as evaluated by the Investigator.
12. Positive serology test for Hepatitis B Virus or Hepatitis C Virus infection, or aspartate 
transaminase or alanine aminotransferase > 3 x upper limit of normal at Screening.3
13. Patient with diagnosed stage III or IV New York Heart Association (NYHA) heart failure.
(Appendix 7)
14. Patient who has an active malignancy.a
15. History of a clinically significant illness and/or clinically significant surgery within the past 14 
days preceding the Screening Visit as determined by the Investigator.
16. Patient who is enrolled in another interventional clinical study.
Test Product, Dose, and Mode of Administration:
AMIA APD Solution Generation System, Dextrose Concentrate and Electrolyte Concentrate.
To be used in patients currently receiving PD with the AMIA or HomeChoice PD System and Dianeal 
PD Solution.
Duration of Treatment:
Each patient will participate in the study for approximately 18 weeks. The Study Periods are as follows:
•
Screening Period including home suitability assessment, feed water testing, and home installation, 
when suitable – approximately 3 weeks.
•
Baseline Period (In-center Training Period) – approximately 2 weeks.
•
Study Treatment Period - 12 weeks.
•
Follow-up Period – 5-10 days following the last treatment with the AMIA APD Solution 
Generation System.
•
End of Study/ Early Termination Visit (occurring on the last day of the Follow-up Period [day 5-
10]).
                                                
a Please note, cancers determined to be cured or in remission for ≥ 1 years, curatively resected basal cell or 
squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps are acceptable diagnosis.

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Study Endpoints:
Primary Endpoints:
Primary efficacy endpoint is:
•
Testing of the chemical composition of the final dialysis solution produced by patients using the 
AMIA APD Solution Generation System, during simulated treatment, compared to the 
specifications of Baxter’s approved Dianeal Low Calcium (2.5 mEq/L) PD Solution.
Primary safety endpoints are:
•
Microbiological (including endotoxin) and chemical testing of product water from the WD (pre-
sterilizing filters) per ISO Standard 13959.1
•
Microbiological testing of water in the holding bag (post-sterilizing filters) to confirm that the 
water does not exceed 0 colony forming units (CFU)/mL for bacteria (no growth) and is < 0.03
endotoxin units (EU)/mL for endotoxins, consistent with Dianeal specifications for sterility.
Secondary Endpoints:
•
Safety profile of the AMIA APD Solution Generation System used to treat patients with PD by 
collecting AEs, SAEs, ADEs, SADEs, incidence of device alarms and vital signs.
•
Peritoneal dialysis adequacy will be measured by sample collection and calculation of total 
Kt/Vurea, occurring one time during Week 5, 6, 7 or 8 of the Study Treatment Period.
Statistical Methods:
General Considerations:
Further details of the planned statistical methods will be provided in the study statistical analysis plan 
(SAP). The SAP will be finalized prior to database lock. Any changes to the statistical methods 
described in the protocol will be documented in the SAP.
Unless otherwise noted, all analyses will be performed using SAS/GRAPH® 9.4 software, SAS/STAT®
14.1 software and Base SAS® 9.4. Copyright© 2002-2012, SAS Institute Inc. SAS and all other SAS 
Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc., 
Cary, NC, USA. All Rights Reserved.4
Summary statistics will be presented with mean, standard deviation, median, minimum and maximum 
for continuous variables and frequency count and percentage based on study population will be used to 
summarize categorical variables. Prior to analysis, data will be reviewed for consistency. Missing data 
values will not be imputed and all non-missing values will be used.
Determination of Sample Size:
A formal sample size calculation was not performed. Up to 50 patients will be enrolled such that a total 
target of 30 evaluable patients complete the 12-week Study Treatment Period and the Follow-up Period.
Analysis Populations:
The Safety Set is based on the intent-to-treat principle and will include all patients who have received at 
least one treatment with the AMIA APD Solution Generation System and who have at least one 
measurement for the primary endpoint (either primary efficacy or primary safety).
Demographics and Baseline Characteristics:
Demographic data include age, gender, race, height, weight, body mass index calculated as weight 
(kg)/height2 (m), and ethnicity.
Other baseline/ demographic data will include total Kt/Vurea which will be summarized by sample size, 
mean, standard deviation, median, minimum and maximum.
Demographic and baseline characteristics will be summarized on the Safety Set.
Primary Analysis:
Primary Efficacy:
AMIA APD Generated Solution specifications will be collected from the final dialysis solution 
generated by the patient using the AMIA APD Solution Generation System, during simulated treatment.

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The chemical composition measurements taken from the final PD solution will be summarized by count 
and percentage for those that meet specification vs those that do not. Summary statistics including 
sample size, mean, standard deviation, median, minimum and maximum will also be presented for the 
chemical composition measures of the solution. These summaries will be provided on the Safety Set.
Primary Safety:
Product water from the WD (pre-sterilizing filters) and water in the holding bag (post-sterilizing filters),
generated during simulated treatments will be sampled. The measurements of product water will be 
summarized by count and percentage for those that meet ISO Standard 139591 for microbiological 
(including endotoxin) and chemical contamination vs those that do not, and the measurements from the 
holding bag will be summarized by count and percentage for those that achieve 0 CFU/mL (no growth)
and <0.03 EU/mL vs those that do not. Both measures will also be summarized by sample size, mean, 
standard deviation, median, minimum and maximum. These summaries will be provided on the Safety 
Set.
Secondary Analysis:
Adverse events will be mapped to a Primary System Organ Class and Preferred Terms according to 
MedDRA Version 21.0 or higher and summarized using frequencies and percentages. In addition, AEs 
will be summarized by seriousness, severity, and relationship to study product or typical PD therapy. 
Device alarms and their relation to AEs or SAEs will be summarized using frequency counts and 
percentages. Vital Signs (BP, pulse, temperature) will be summarized by mean, standard deviation, 
median, minimum and maximum for all recorded timepoints and also for change from pre-to post 
treatment for all post Baseline timepoints. These summaries will be conducted on the Safety Set.
Total Kt/Vurea will be summarized using descriptive statistics at all collection timepoints and change 
from Baseline will also be summarized. This summary will be performed on the Safety Set.
Interim Analysis:
An interim analysis is not planned for this study.
Date of Original Approved Protocol:
2018 JUN 15
Date of Most Recent Protocol Amendment:
2019 NOV 01

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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS
AE
Adverse Event
ADE
Adverse Device Effect
ADR
Adverse Drug Reaction
AESI
Adverse Event of Special Interest
APD
Automated Peritoneal Dialysis
AR
Adverse Reaction
BAD
Baxter Awareness Date
β-hCG
Beta Serum Human Chorionic Gonadotropin
BP
Blood Pressure
CBC
Complete Blood Count
CFR
Code of Federal Regulations
CFU
Colony Forming Units
DD
Device Deficiency
EDC
Electronic Data Capture
eDiary
Electronic Diary
ESRD
End Stage Renal Disease
eCRF
Electronic Case Report Form
EP
European Pharmacopoeia
EU
Endotoxin Units
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HBsAg
Hepatitis B Surface Antigen
HCV
Hepatitis C Virus
HIPAA
Health Information Portability and Accountability Act
ICF
Informed Consent Form
ICH
International Conference on Harmonization 
IIPV
Increased Intraperitoneal Volume
IND
Investigational New Drug Application
IP
Intraperitoneal
IRB
Institutional Review Board
Kt/Vurea
Dimensionless Number Used to Quantify Hemodialysis and 
Peritoneal Dialysis Adequacy
NAT
Nucleic Acid Testing
NF
National Formulary
NYHA
New York Heart Association

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PC
Product Complaint
PD
Peritoneal Dialysis
PI
Principal Investigator
QS
Quantity Sufficient
RO
Reverse Osmosis
SADE
Serious Adverse Device Effect
SADR
Serious Adverse Drug Reaction
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SAR
Serious Adverse Reaction
SUSAR
Suspected Unexpected Serious Adverse Reaction
UADR
Unexpected Adverse Drug Reaction
UF
Ultrafiltration
USP
United States Pharmacopoeia
WCC
White Cell Count
WD
Water Device

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1. INTRODUCTION
1.1 Background 
Peritoneal dialysis (PD) is a well-established treatment for renal failure including long-
term management of end stage renal disease (ESRD) by continuous ambulatory 
peritoneal dialysis or automated peritoneal dialysis (APD). It is a procedure for removal 
of uremic toxins which are normally excreted by the kidneys, and for aiding the 
regulation of fluid and serum electrolytes as well as acid-base balance. In patients with 
renal failure, during PD, uremic toxins, present in high concentrations in the blood, cross 
the peritoneal membrane into the dialyzing fluid, according to the principles of osmosis 
and diffusion. Peritoneal dialysis solutions contain variable amounts of glucose, all of 
them being hyperosmolar to the plasma, creating an osmotic gradient which facilitates 
fluid removal from the plasma to the solution.
Peritoneal dialysis, as discussed by Popovich in 19765 is now an established form of 
therapy to manage patients with ESRD. This therapy is integrated with other modalities 
such as hemodialysis and transplantation, with approximately 11% of all dialysis patients 
globally currently being treated with PD.6
Complementary therapies offer longer-term survival for patients with ESRD. However, 
none of them are devoid of side effects and today their limitations are better understood 
by the nephrologist.
The AMIA APD Solution Generation System consists of the AMIA APD Cycler, 
Sharesource Platform, AMIA APD Concentrates (a Dextrose Concentrate and an 
Electrolyte Concentrate), a disposable set (containing a cassette, a water line with holding 
bag and two sterilizing grade filters, a heater bag, a patient line, a dextrose concentrate 
line, a last fill solution line, an electrolyte concentrate line, and a drain line), a bag tray, a 
Water Softener
 and a Water Device (WD). 
 
 
 
 

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The AMIA APD Solution Generation System is intended for automatic control of dialysis
solution exchanges in the treatment of adult renal failure patients undergoing PD in home
or clinic environments.
The AMIA APD Solution Generation System is a drug-device combination product. All 
therapies using the AMIA APD Solutions Generation System must be prescribed and 
performed under the responsibility of a physician who is well informed about PD and the 
study system.

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The system is designed to produce dialysis solution as prescribed by the clinician. The
resulting AMIA APD Generated Solution will be mixed from the sterile AMIA APD 
Concentrates (a Dextrose Concentrate and an Electrolyte Concentrate) and sterile, non-
pyrogenic water (post-sterilizing filters). Table 1 lists the composition of the Dextrose
Concentrate, Table 2 lists the composition of the Electrolyte Concentrate, and Table 3
lists the composition of the AMIA APD Generated Solution. AMIA APD Generated 
Solution is formulated to have a nominal solution chemistry that is equivalent to the 
labeled composition of Dianeal Low Calcium (2.5 mEq/L), in three standard dextrose 
strengths (1.5%, 2.5% and 4.25%) (See 0). The use of Dianeal low calcium solution is 
supported by ISPD guidelines suggesting a low calcium (2.5 mEq/L) PD solution to 
avoid positive calcium balance or hypercalcemia.7 Consistent with the ISPD guidelines, 
Dianeal Low Calcium constituted approximately 92% of total Dianeal used in 2017 in the 
US.
Table 1. Composition of Dextrose Concentrate
Component
Component Quantity
Quality Standard
g/L (nominal)
Dextrose Hydrous
USP
550.0
Hydrochloric Acid
NF
pH adjuster
Water for Injection
USP/EP
QS
USP = United States Pharmacopeia; NF = National Formulary; EP = European Pharmacopoeia; QS = 
Quantity sufficient
Table 2. Composition of Electrolyte Concentrate
Component
Component Quantity
Quality Standard
g/L (nominal)
Calcium Chloride, Dihydrate
USP
3.675
Magnesium Chloride, Hexahydrate
USP
1.017
Sodium Chloride
USP
107.5
Sodium Lactate Solution
USP
89.65
Water for Injection
USP/EP
QS
USP = United States Pharmacopeia; EP = European Pharmacopoeia; QS = Quantity sufficient

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Table 3. Composition of the AMIA APD Generated Solution (mmol/L)
Component
1.5% Dextrose
2.5% Dextrose
4.25% Dextrose
Dextrose
75.5 
126
214
Sodium
132
132
132
Calcium
1.25
1.25
1.25
Magnesium
0.25
0.25
0.25
Chloride 
95
95
95
Lactate
40
40
40
pH
~ 6
~ 6
~ 6
The AMIA APD Concentrates, after dilution by the AMIA APD Solution Generation
System, are indicated for adult patients in acute or chronic renal failure when non-dialytic 
medical therapy is judged to be inadequate.
•
The AMIA APD Concentrates are only intended to be used together, and only as a 
part of the AMIA APD Solution Generation System.
•
The Dextrose Concentrate is a sterile, non-pyrogenic product used in the 
preparation of the AMIA APD Generated Solution when using the AMIA APD 
Solution Generation System.
•
The Electrolyte Concentrate is a sterile, non-pyrogenic product containing the 
electrolytes and buffer used in the preparation of the AMIA APD Generated 
Solution when using the AMIA APD Solution Generation System.
1.2 Benefits and Risks for the Study Population
Peritoneal dialysis is a well-established life-sustaining medical renal replacement therapy 
for individuals with ESRD. Dextrose-based dialysis solutions, such as AMIA APD 
Generated Solution, produced by the AMIA APD Solution Generation System, continue 
to be the fundamental basis of PD therapy. The AMIA APD Solution Generation System 
can produce AMIA APD Generated Solution in three standard dextrose concentrations
(1.5%, 2.5% and 4.25%).
When prepared as part of the AMIA APD Solution Generation System, the AMIA APD 
Generated Solution is a pharmacologically inactive, hypertonic PD solution containing 
dextrose, a monosaccharide, as the primary osmotic agent. An osmotic gradient must be 
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to occur. The hypertonic concentration of dextrose in the AMIA APD Generated Solution 
exerts an osmotic pressure across the peritoneal membrane resulting in transcapillary UF. 
Like other PD solutions, the AMIA APD Generated Solution contains electrolytes to 
facilitate the correction of electrolyte abnormalities. The AMIA APD Generated Solution 
contains a buffer, lactate, to help normalize acid-base abnormalities.
Patients treated with the AMIA APD Solution Generation System will also benefit from 
reduced physical strain due to less weight in solution bags, reduction in storage space 
required for solutions, and less packaging waste (e.g., empty solution containers and 
cardboard shipping containers) to manage.
During the study, patient or care partner (if participating) will be required to document 
treatment information in the electronic diary (eDiary), as instructed by the Investigator. 
Patient will be expected to comply with study treatment instructions, conduct simulated 
treatments and attend Study Visits.
There are inherent risks to PD therapy. Similar to PD therapies with other dextrose-based 
solutions, such as Dianeal, there are potential risks associated with the use of the AMIA 
APD Solution Generation System. AMIA APD Generated Solution is expected to have 
the same safety profile as Dianeal PD Solution. Important identified risks with Dianeal 
and other dextrose-based solutions that will be applicable to the AMIA APD Generated 
Solution include: aseptic peritonitis, hypovolemia, hypokalemia, hyponatremia, 
encapsulating peritoneal sclerosis, and medication error - administration of incorrect 
glucose concentration. Important potential risks include lactic acidosis, hyperglycemia, 
and hypocalcemia.
Overall, the benefits outweigh the potential adverse effects of using AMIA APD 
Generated Solution in patients with ESRD for which PD therapy is indicated. Therefore, 
the benefit-risk balance is positive for AMIA APD Generated Solution. Participation of 
PD patients in this prospective study may support future opportunity of PD patients to 
benefit from a potential access to this approach to PD treatment.
1.3 Study Sponsor
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL 60015 USA

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2. STUDY OBJECTIVES
2.1 Primary Objectives
Efficacy
To evaluate the chemical composition of the final dialysis solution produced by patients 
using the AMIA APD Solution Generation System during simulated treatment, compared 
to the specifications of Baxter’s approved Dianeal Low Calcium (2.5 mEq/L) PD 
Solution.
Safety
To evaluate the product water from the WD (pre-sterilizing filters) as meeting ISO 
standard 139591 for microbiological (including endotoxin) and chemical contamination,
and water in the holding bag (post-sterilizing filters) as meeting system microbiological 
requirements, when produced in patients’ homes using the AMIA APD Solution 
Generation System, during a simulated treatment.
2.2 Secondary Objectives 
•
To evaluate the safety of the AMIA APD Solution Generation System, used to 
treat patients with ESRD, by collecting adverse events (AEs), serious adverse 
events (SAEs), adverse device effects (ADEs), serious adverse device effects
(SADEs), incidence of device alarms and vital signs.
•
To assess PD adequacy by calculation of total Kt/Vurea.
3. INVESTIGATIONAL PLAN
3.1 Overall Study Design and Plan
This is an open-label, single arm, prospective, descriptive study. Up to 50 PD patients,
who are stable on in-home APD using the AMIA or HomeChoice APD Cycler, will be 
enrolled in this study such that a total target of 30 evaluable patients complete the 12-
week Study Treatment Period and the Follow-up Period.
During the Screening Period, all consenting patients will have a home assessment,
including feed (tap) water analysis, to confirm their home environment is suitable for this 
study. Eligible patients will be followed for data collection regarding dialysate solution 
composition and safety while using the AMIA APD Solution Generation System.

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Data will be collected throughout the duration of the study (approximately 18 weeks), 
including the Screening Period, Baseline Period (In-center Training Period), Study 
Treatment Period, Follow-up Period and the End-of-Study Visit/ Early Termination Visit.
All AEs (not reported as medical history), product complaints (PCs) and device 
deficiencies (DDs) observed by the study personnel or reported by the patient during the 
course of the study will be documented from the time of signing the informed consent 
form (ICF) through the End-of-Study/ Early Termination Visit. The Principal Investigator
(PI) or designee (e.g., sub-investigator) will assess each patient at the Screening Visit and 
on a weekly basis, according to standard of care. At a minimum, this assessment will
include evaluation of BP, pulse rate, weight, fluid status and dialysis prescription.
Laboratory data will be collected at Screening and during the use of the AMIA APD 
Solution Generation System.
Evaluations will be taken as illustrated in Appendix 1 and Appendix 2. A trial scheme for 
the study is shown in Figure 2 below.
Figure 2. Overview of Study Assessments
3.2 Study Endpoints
3.2.1 Primary Endpoints
Primary efficacy endpoint is:
•
Testing of the chemical composition of the final dialysis solution produced by 
patients using the AMIA APD Solution Generation System, during simulated 
treatment, compared to the specifications of Baxter’s approved Dianeal Low 
Calcium (2.5 mEq/L) PD Solution.

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Primary safety endpoints are:
•
Microbiological (including endotoxin) and chemical testing of product water from 
the WD (pre-sterilizing filters) per ISO Standard 13959.1
•
Microbiological testing of water in the holding bag (post-sterilizing filters) to 
confirm that the water does not exceed 0 colony forming units (CFU) /mL for 
bacteria (no growth) and is <0.03 endotoxin units (EU)/ mL for endotoxins, 
consistent with Dianeal specifications for sterility.
3.2.2 Secondary Endpoints
•
Safety profile of the AMIA APD Solution Generation System used to treat 
patients with PD by collecting AEs, SAEs, ADEs, SADEs, incidence of device 
alarms and vital signs.
•
Peritoneal dialysis adequacy will be measured by sample collection and 
calculation of total Kt/Vurea, occurring one time during weeks 5, 6, 7 or 8 of the 
Study Treatment Period.
3.3 Rationale for Study Design and Control Group
The rationale for using an open-label, single arm, prospective, descriptive study design
without a control group is that it allows Baxter to generate clinical use system 
performance and safety data on the AMIA APD Solution Generation System therapy
when used by patients within the current population of patients performing APD therapy 
using the AMIA APD Cycler. The primary endpoints in this study, involve testing of the 
final dialysis solution, product water (pre-sterilizing filters) and water in the holding bag 
(post-sterilizing filters) produced by the patients using the AMIA APD Solution 
Generation System during a simulated treatment. The chemical composition of the final 
dialysis solution will be compared to the specifications of Baxter’s approved Dianeal 
Low Calcium (2.5 mEq/L) PD Solution.
The product water from the WD (pre-sterilizing filters) will be collected and tested 
against ISO Standard 139591 for microbiological (including endotoxin) and chemical 
contamination. The water in the holding bag (post-sterilizing filters) will be collected and 
tested to confirm that it does not exceed 0 CFU/mL for bacteria (no growth) and is <0.03
EU/mL for endotoxins, consistent with Dianeal specifications for sterility. As such, the 
goal of this clinical study is to demonstrate that the AMIA APD Solution Generation 

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System generates a dialysis solution equivalent to Baxter’s approved Dianeal Low 
Calcium (2.5 mEq/L) PD Solution. (See 0).
3.4 Study Duration and Dates
Each patient will participate in the study for approximately 18 weeks. The Study Periods 
are as follows:
•
Screening Period including home suitability assessment, feed water testing, and 
home installation when suitable – approximately 3 weeks.
•
Baseline Period (In-center Training Period) – approximately 2 weeks.
•
Study Treatment Period - 12 weeks.
•
Follow-up Period – 5-10 days following the last treatment with the AMIA APD 
Solution Generation System.
•
End of Study/ Early Termination Visit (occurring on the last day of the Follow-up 
Period [day 5-10]).
3.5 Study Intervention Discontinuation and Patient Discontinuation/Withdrawal
3.5.1 Removal of Patients from Therapy, Assessment, or Study
A patient is considered withdrawn/prematurely discontinued from the study if his/her 
participation is discontinued before completion of the required evaluations as specified in 
the protocol. Patient is free to withdraw from participation in the study at any time upon 
request. An Investigator may discontinue or withdraw a patient from the study for the 
following reasons:
1. If any clinical AE, laboratory abnormality, or other medical condition or situation 
occurs such that continued participation in the study would not be in the best 
interest of the patient.
2. Inadequate dialysis, based on PI judgement.
3. Protocol violation (e.g., the patient failed to meet protocol entry criteria or did not 
adhere to the protocol requirements).
4. Disease progression which requires discontinuation of the study intervention.
5. If the participant meets an exclusion criterion (either newly developed or not 
previously recognized) that precludes further study participation.
6.
Pregnancy.

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7.
Renal transplant.
8.
Death.
9. Changes to another dialysis center.
10. Home feed water affected by “boil water advisory”.
11. Lost to follow-up (i.e., patient fails to return for the End of Study Visit).
12. Voluntary withdrawal (i.e., patient’s request).
13. Termination of the study.
14. Investigator’s discretion.
15. Patient misses more than 4 consecutive days of prescribed therapy with the AMIA 
APD Solution Generation System (including hospitalizations and device issues). 
If a patient misses 4 consecutive days of prescribed therapy with AMIA APD 
Solution Generation System then the total Kt/Vurea assessment (between Weeks 
5 - 8) should be deferred by 1 week to allow a full week of prescribed treatment 
using the AMIA APD Solution Generation System. Note: after patients have
completed the total Kt/Vurea assessment required during Week 5, 6, 7 or 8 of the 
Study Treatment Period, in order to accommodate potential vacation/travel, 
patients may voluntarily interrupt investigational AMIA APD Solution 
Generation System treatment and perform standard of care PD therapy using the 
marketed AMIA or HomeChoice APD Cycler with currently available PD 
solution (e.g. Dianeal) up to 2 separate times with prior approval from the 
Investigator for up to 14 days in total; however, patients must complete a total of 
12 weeks of cumulative therapy using the AMIA APD Solution Generation 
System.
16. Patients who withdraw from study due to missed therapy due to AMIA APD 
water device replacement may be allowed to rescreen to re-enroll up to 1 time, as 
assessed by Investigator and Sponsor.
17. Patient consistently misses more than 1 prescribed treatment per week, as 
assessed by the Investigator, over the course of the 12-week Study Treatment 
Period.
18. Other reason (with reason noted on the electronic case report form [eCRF]).
The reason for patient discontinuation or withdrawal from the study will be recorded on 
the appropriate page of the eCRF. A patient who signs the ICF but does not receive the 

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study treatment may be replaced. Patient who signs the ICF and receives the study 
treatment, and subsequently withdraws, or is withdrawn or discontinued from the study, 
will not be replaced.
3.5.2 Discontinuation of the Study
If a clinically significant finding is identified (including, but not limited to changes from 
Baseline) during the clinical investigation, the Sponsor, Investigator, the Institutional 
Review Board (IRB) or regulatory authorities will determine if any change in patient 
management is needed. Any new clinically relevant finding will be reported as an AE.
Risks to a patient that may warrant discontinuation of the study include but are not 
limited to:
•
Device malfunction, considered by the Investigator and/or Baxter Healthcare 
Corporation as possibly leading to a deficiency in the patient’s treatment.
•
Unexpected/Unanticipated AE or ADE.
The Sponsor shall review untoward events and assess risks during the conduct of the 
clinical investigation. The Sponsor shall terminate the clinical investigation if an 
unacceptable risk is confirmed. Decision to restart the study will be made jointly by 
Baxter Healthcare Corporation, the regulatory authority, the site-specific IRB and the PI
following evaluation of the problems encountered.
4. STUDY POPULATION SELECTION
4.1 Study Population
The study population consists of patients with ESRD treated with PD using the AMIA 
APD Solution Generation System. Up to 50 patients receiving a regimen of PD with the 
AMIA or HomeChoice APD Cycler for at least 12 weeks will be enrolled in this study 
such that a total target of 30 evaluable patients complete the 12-week Study Treatment 
Period and the Follow-up Period.
4.2 Inclusion Criteria
Each patient must meet ALL of the following criteria to be enrolled in this study:
1. Patient is 18 years or older.
2. Patient with ESRD receiving PD therapy, and who is already trained and regularly 
using the AMIA or HomeChoice APD Cycler with Dianeal PD Solution for at 
least 12 weeks.

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3. Patient is receiving or willing and able to use Dianeal Low Calcium (2.5 mEq/L) 
PD prescriptive regimen at study treatment initiation per Investigator’s 
assessment.
4. Patient demonstrates adequate PD therapy with clinical euvolemia as assessed by 
the Investigator with a total Kt/Vurea of a minimum of 1.7 within 45 days of 
Screening2, or measured at Screening. If a total Kt/Vurea is not available within 45 
days of Screening, it will be measured at Screening.
5. Investigator assesses that, with appropriate training, the patient will be able to 
successfully manage his/her dialysis treatments with the AMIA APD Solution 
Generation System.
6. Patient is available and is willing to complete training on the AMIA APD 
Solution Generation System.
7. Patient and home environment are deemed suitable for treatment with the AMIA 
APD Solution Generation System, while in the home.
8. Home electrical and water assessments meet suitability criteria for the AMIA 
APD Solution Generation System.
9. The patient’s home has suitable wireless connection or patient is willing to allow 
installation of suitable wireless connection.
10. Patient and/or care partner (if participating) (See Section 5.4.1) is able to read and 
understand English, and provide informed consent after an explanation of the 
proposed study. If the patient does not read and understand English, patient may 
still participate if he/she has a co-residing care partner who reads and understands 
English, assessed as adequate by the PI.
11. Women of childbearing potential (not menopausal or surgically sterile) must not 
be pregnant. Serum qualitative and quantitative pregnancy test will be done within 
14 days prior to initiation of study product.
-
If qualitative serum β-hCG results are positive, repeat quantitative serum 
pregnancy test in 48 hours.
-
If quantitative serum β-hCG levels show clinically significant rise within 48 
hours, serum progesterone level should be taken. Serum progesterone
> 5 ng/mL will exclude a patient from the study.

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12. Sexually active males and females agree to use a reliable means of contraception 
during the study and for 30 days afterwards (e.g., oral contraceptive and condom, 
intrauterine device and condom, or diaphragm with spermicide and condom).
4.3 Exclusion Criteria
Patient who meets ANY of the following criteria will be excluded from the study:
1. Patient with a history of PD catheter dysfunction within 12 weeks prior to study 
enrollment, as evaluated by the Investigator.
2. Patient who had episodes of peritonitis or exit site infection within 12 weeks prior 
to study enrollment.
3. Patient who has signs of impending or current infection including a cloudy 
dialysis effluent or dialysis white cell count > 100/ µL or > 0.1 x 109/ L (after a 
dwell time of at least 2 hours), with > 50% polymorphonuclear cells, and/or 
positive dialysis effluent culture.
4. Patient who has a severe primary immune deficiency or other condition that may 
mask clinical signs of peritonitis, as evaluated by the Investigator.
5. Patient with a history of repeated non-compliance with PD, therapy (e.g., a 
substantial number of missed clinic visits, missed treatments or a history of 
mismanagement of diet or medications), as evaluated by the Investigator.
6. Patient who has acute renal failure with the chance for recovery.
7. Patient who is pre-scheduled for a living donor kidney transplant within the next 6 
months.
8. Patient who is not expected to live at least 6 months while maintaining PD 
treatment.
9. Patient who had major abdominal surgery within 6 months prior to study 
enrollment.
10. Patient with current abdominal hernia, as evaluated by the Investigator.
11. Patient with advanced liver or pulmonary disease, as evaluated by the 
Investigator.
12. Positive serology test for Hepatitis B Virus or Hepatitis C Virus infection, or 
aspartate transaminase or alanine aminotransferase > 3 x upper limit of normal at 
Screening.3

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13. Patient with diagnosed stage III or IV New York Heart Association (NYHA) heart 
failure. (Appendix 7)
14. Patient who has an active malignancy.b
15. History of a clinically significant illness and/or clinically significant surgery 
within the past 14 days preceding the Screening Visit as determined by the 
Investigator.
16. Patient who is enrolled in another interventional clinical study.
4.4 Home Assessment and Installation
During the Screening Period, all consented patients will have a home assessment to 
confirm the patient’s home environment is suitable for the study. The patient’s home 
environment must meet the AMIA APD Solution Generation System requirements to be 
eligible for enrollment (Refer to AMIA APD Solution Generation System Patient Guide
for details of the system requirements).8 To provide schedule flexibility for the consented 
patient, Baxter Service or its designee may begin the home installation process during the 
Screening Period. System installation and product water from the WD (pre-sterilizing
filters) testing are expected to take approximately two weeks. This will ensure the system 
is ready for activation after the patient completes his/her required in-center training on 
the AMIA APD Solution Generation System.
4.5 Recruitment
Once the Food and Drug Administration (FDA) has reviewed and accepted the 
Investigational New Drug (IND) Application and a site’s IRB has also reviewed and 
approved the study for its respective study center, Baxter will review the site’s 
documentation and then notify the site once it is approved to recruit and screen study 
patients. Sites must wait until they receive confirmation from Baxter that they are 
“approved to screen” before recruiting patients.
                                                
b Please note, cancers determined to be cured or in remission for ≥1 years, curatively resected basal cell or 
squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps are acceptable diagnosis.

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5. STUDY TREATMENT(S)
5.1 Description of Treatment(s)
5.1.1 Study Product: AMIA APD Solution Generation System
The AMIA APD Solution Generation System is intended for automatic control of 
dialysate solution exchanges in the treatment of adult renal failure patients undergoing 
PD in home or clinic environments.
All therapies using the AMIA APD Solution Generation System are to be prescribed and 
performed under the supervision of a study physician who is well informed about PD and 
the study system. AMIA APD Generated Solution is to be administered intraperitoneally.
The AMIA APD Solution Generation System is a drug-device combination product. The 
AMIA APD Solution Generation System includes the AMIA APD Cycler, the WD, 
Sharesource Platform, the AMIA APD Concentrates, a disposable set, and a bag tray. The 
bag tray is a platform for the AMIA APD Cycler to be placed on, and to hold the 
concentrate and holding bags.
The AMIA APD Cycler consists of:
•
AMIA APD Cycler.
•
Solution Generation System Link Module with Bluetooth technology for wireless 
communication with the WD.
The WD consists of:
•
Pre-treatment filter pack.
•
Reverse osmosis membrane.
•
Heater.
•
Conductivity and temperature sensors.
•
Ports for patient connection (product water and drain line).
•
Water Softener (this is an accessory to the WD).
The disposable set consists of:
•
Cassette.
•
Holding bag.

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•
Heater bag.
•
Two inline sterilizing grade filters.
•
Patient line.
•
Dextrose line.
•
Electrolyte line.
•
Last fill solution line.
•
Drain line.
AMIA APD Concentrates include:
•
An Electrolyte Concentrate.
•
A Dextrose Concentrate.
The AMIA APD Solution Generation System mixes dialysis solution generated from the 
AMIA APD Concentrates and sterile, non-pyrogenic water (post-sterilizing filters). The 
AMIA APD Cycler requests the volume of water needed to generate enough solution for 
the next patient fill. While delivering appropriate volumes of water and concentrates to 
the heater bag, the AMIA APD Cycler mixes the solution. Once the solution is mixed, the 
AMIA APD Cycler sends a small volume of solution from the heater bag to the WD to 
perform a conductivity check prior to delivering the solution to the patient.
The WD generates dialysis quality water (sterile non-pyrogenic water) from feed water 
using the Water Softener, a pre-treatment filter pack, and a RO membrane.
The Water Softener removes impurities and hardness. The feed water enters the Water 
Softener and passes through three different resins with diverged qualities to remove 
impurities from the feed water.
Pre-treatment is a process for removing total chlorine. The feed water enters the 
replaceable filter pack and flows through the mechanical filter and activated carbon for 
purification.
Reverse osmosis is a membrane process and the most widely used technique for 
purification of water for dialysis. When the feed water is in contact with the 
semipermeable membrane, the most vital part of the system, and a high pressure is 
applied, water will flow through the membrane to the permeate water side. Most of the

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other constituents, such as dissolved salts, particles, bacteria and pyrogens, will remain 
on the feed water side of the membrane and be flushed to the drain as components of the 
reject water.
5.2 Enrollment, Randomization, and Assignment to Treatment Group
This is an open-label, single-arm study, and patients will not be randomized. Only 
patients who have signed the ICF and have met the entry criteria will be allowed to 
continue their participation in the study. Following signing the ICF, the patients will also
undergo a Screening Visit and a home suitability assessment. (Please refer to the Point of 
Care APD Clinic and Home Assessment Guide for the procedures involved in the home 
suitability assessment.)9
Up to 50 patients receiving a regimen of PD with the AMIA or HomeChoice APD Cycler 
for at least 12 weeks will be enrolled in this study such that a total target of 30 evaluable 
patients complete the 12-week Study Treatment Period and the Follow-up Period. At the 
discretion of the Sponsor, continued enrollment or initiation of treatment with the AMIA 
APD Solution Generation System may be discontinued once the Sponsor reaches a 
sufficient number of patients enrolled to achieve a target goal of 30 patients completing 
the 12-week Study Treatment Period and the Follow-up Period. All patients will be 
treated with the AMIA APD Solution Generation System.
5.3 Treatment Duration and Study Visits
The treatment duration will be 12 weeks. Patients will receive PD treatment, as 
prescribed, in their home throughout the duration of the study. After patients have
completed the Kt/Vurea assessment required during Week 5, 6, 7 or 8 of the Study 
Treatment Period, in order to accommodate potential vacation/travel, they may 
voluntarily interrupt investigational AMIA APD Solution Generation System treatment 
and perform standard of care PD therapy using the marketed AMIA or HomeChoice APD 
Cycler with currently available PD solution (e.g. Dianeal) up to 2 separate times with 
prior approval from the Investigator for up to 14 days in total; however, patients must 
complete a total of 12 weeks of cumulative therapy using the AMIA APD Solution 
Generation System. If required, per patient prescription and if the patient has been 
treating with premixed Extraneal prior to study enrollment, premixed Extraneal may be 
used for the last fill.
Baseline assessments will occur during the Baseline Period (In-Center Training Period)
before patients initiate treatment with the AMIA APD Solution Generation System (See 
Section 8.4 for details of assessments occurring at Baseline).

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Simulated treatments will occur in addition to the patient’s normal therapy regimen. The 
simulated treatment will take place before the patient receives study treatment. The initial 
simulated treatment will occur before the first treatment in the home with the AMIA APD 
Solution Generation System, Study Treatment Week 1 (Study Visit 1). Simulated 
treatments will continue during Study Treatment Weeks 4 (Study Visit 2), 8 (Study Visit 
3) and 12 (Study Visit 4). Patients will be required to use new AMIA APD Concentrates 
and disposable sets for their treatment, following a simulated treatment.
The dialysis solution generated by the simulated treatment will be collected from the 
system in the heater bag and used to evaluate the chemical composition of the final 
dialysis solution produced by patients using the AMIA APD Solution Generation System, 
compared to the specifications of Baxter’s approved Dianeal Low Calcium (2.5 mEq/L) 
PD Solution.
The product water from the WD (pre-sterilizing filters) will be collected and tested 
against ISO standard 13959 for microbiological (including endotoxin) and chemical 
contamination.1 The water in the holding bag (post-sterilizing filters) will be collected 
and tested to confirm it does not exceed 0 CFU/mL for bacteria (no growth) and is < 0.03
EU/mL for endotoxins, consistent with Dianeal specifications for sterility.
Study Visits 2, 3 and 4 will occur during Study Treatment Weeks 4, 8 and 12, 
respectively. Refer to Section 8.7 for details of assessments occurring at each Study Visit.
5.4 Selection and Timing for Each Patient
Home suitability assessment and feed water testing will occur during the Screening
Period. Home installation and product water testing are to occur during the Screening
and/or the Baseline Period (In-center Training Period) to provide the most flexibility in 
patient’s schedule. Patient will receive in-center training on the use of the system, which 
is to last approximately 2 weeks and is to begin after the Screening Period. Patient will 
continue to treat with standard AMIA or HomeChoice APD Cycler with Baxter’s 
approved Dianeal Low Calcium (2.5 mEq/L) PD Solution during the Baseline Period (In-
center Training Period). Baseline assessments are to occur during the Baseline Period (In-
center Training Period) before the first treatment with the AMIA APD Solution 
Generation System. Patient will receive instructions on how to record his/her daily PD 
treatment and how to collect 24-hour peritoneal effluent and urine.
Following completion of the Baseline Period (In-center Training Period), the 12-week 
Study Treatment Period of in-home PD treatments using the AMIA APD Solution 
Generation System, will begin. The initial simulated treatment is to occur before the

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patient administers his/her first PD treatment using AMIA APD Solution Generation 
System at home (Study Visit 1). Simulated treatments will continue during weeks 4 
(Study Visit 2), 8 (Study Visit 3) and 12 (Study Visit 4) of the Study Treatment Period. 
After the last treatment with the AMIA APD Solution Generation System, patient is to
transition back to Standard AMIA or HomeChoice treatment with Baxter’s approved
Dianeal Low Calcium (2.5 mEq/L) PD Solution and enter a Follow-up Period of 5-10
days. Return of all investigational products and study related supplies will be scheduled 
during this time. The End-of-Study Visit is to occur on day 5-10 of the Follow-up Period.
The dialysis prescription for daytime exchanges should be kept consistent with the
patient’s pre-study prescription. The prescription of daytime dwells will not be modified 
unless determined to be clinically necessary by the Investigator. If a change in 
prescription occurs, it will be recorded in the patient’s source data and accurately
reflected in the eCRF.
5.4.1 Care Partner
Patient may have a care partner in the home to assist with his/her therapy. If participating, 
the care partner must sign the ICF, receive and complete In-center training on the study 
activities and other study procedures to be performed. The care partner’s presence and 
role during the Study Treatment Period will be determined based upon his/her
responsibilities identified during the consent process. If the care partner is trained and 
solely responsible for a treatment activity (e.g., connecting and disconnecting the patient)
and/or if the patient does not read and understand English, the care partner will need to 
reside in the home with the patient and be present to facilitate that activity during all 
treatments within the Study Treatment Period using the AMIA APD Solution Generation 
System. Outside of these requirements, the care partner’s presence will be at the 
discretion of the Investigator.
5.5 Method of Assigning Patients to Treatment Groups
All patients who sign the ICF will be assigned a unique patient number. This is a single-
arm study where all patients will be treated with the AMIA APD Solution Generation 
System. The patient IDs generated at Screening shall be the patient’s ID for the course of 
the study. If a patient is withdrawn or fails Screening and they are later screened to re-
enroll, they will be assigned a new patient ID and must sign a new informed consent. The 
statistical analysis plan (SAP) will indicate how these data will be handled. Data from all 
patient IDs will be retained.

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5.6 Blinding
This is an open-label study that will not utilize blinding of the investigational product. All
patients will be treated with the AMIA APD Solution Generation System. The study site 
team will be instructed to follow their local procedure(s) to ensure the study patients
receive their appropriate treatment.
5.7 Concomitant Therapy
The PI should review any additions or changes in concomitant therapy. Medications 
should be recorded in the source documents or equivalent. Prior medications that are still 
active, defined as those taken during the 30-day window prior to Screening, will be 
recorded on the eCRF. Concomitant medications, including dose, frequency, start and 
stop dates and indication for use, will be recorded on the eCRF throughout the study.
5.8 Prohibitions and Restrictions
There are no activity or diet restrictions specific to the study. Patient should discuss 
his/her daily diet and activities with his/her physician. Patient should only be using 
AMIA APD Generated Solution for treatments, unless he/she has been instructed not to 
use the system by his/her study physician/ nurse (Refer to Section 3.5.2).
5.9 Treatment Compliance
Compliance will be assessed regularly by the Investigator by reviewing the patient’s 
Sharesource Platform data and eDiary entries. The patient (with assistance from the care
partner if the patient does not read and understand English) will be instructed to complete 
the eDiary daily to document treatment activities including, but not limited to, the 
following:
•
Patient status/ condition updates – potential AEs experienced.
•
Treatment interruptions.
•
Confirmation if the patient contacted dialysis center for support with a product or 
health-related issue.
•
Confirmation if the patient was able to sleep during treatment and the estimated 
duration of sleep.
•
Treatment outcome (i.e., complete treatment, incomplete treatment) and reasons 
for incomplete treatment.
•
Confirmation if the patient altered their treatment parameters within the range(s) 
allowed by the Investigator.

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•
Investigational product usage and supply requirements.
•
Document completion of study requirements.
Patients’ responses will be reported electronically to the PI and designees. The site staff 
will use the eDiary data along with the Sharesource Platform machine log data to monitor 
and track the patient following local regulations. This eDiary data will serve as 
supplemental source documentation for the sites to support consistent data collection 
during the Study Treatment Period.
5.10 Packaging and Labeling
All investigational products will be manufactured, handled, stored, and provided to 
patients in accordance with good manufacturing practice regulations and guidance, and 
International Conference on Harmonization (ICH) guidelines for good clinical practice 
(GCP).
All investigational products or their immediate package will bear a label with the 
following information:
1. The name and place of business of the manufacturer, packer, or distributor (in 
accordance with Part 801.1 of Title 21 of the CFR).
2. The name of the investigational product.
3. The following statement “Investigational Device” or “New Drug”
4. The following statement “Limited by Federal law to investigational use.” 
The investigational product label and/ or other labelling will describe all relevant 
contraindications, hazards, AEs, interfering substances or devices, warnings, and 
precautions. 
5.11 Accessibility and Control of Study Participant Data
In order to ship investigational product and service investigational products to/ at 
patients’ homes, a subset of Baxter personnel and designees will need access to shipping 
addresses/ contact information. A study-specific procedure will be created and 
implemented by Baxter Clinical Services to document how Baxter Service and Baxter 
Clinical Services will collect, control, and secure patients’ contact information and 
addresses. Access to the collected data will be restricted to the teams/ team members who 
need the information to appropriately conduct this study. Study patients will have direct 

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communication with Baxter Service personnel and designees to ensure timely 
installation/ service of the investigational product and supply delivery. Baxter personnel 
or designees will service devices directly in patients’ homes, collect samples, and 
designated couriers will deliver specified investigational products (e.g., AMIA APD 
Concentrates) directly into patients’ homes. These groups will communicate through the 
study sites to minimize direct patient interaction where appropriate. The Sponsor will 
ultimately redact all collected confidential information from study documentation when 
patients end their study participation and all investigational products are removed from 
the patients’ homes.
5.12 Storage and Accountability
The study products are to be stored according to label specifications.
The sites and patients will be required to maintain accurate records of the disposition of 
the investigational products (study devices [serial numbers] and drugs [batch numbers]), 
including dates, quantities, serial/ batch/ lot numbers, expiration dates as applicable and 
use in the study. Importantly, the following requirements must be noted:
•
The date of receipt at home and/or site.
•
Identification of each investigational drug (batch number) and device (serial 
number).
•
The date of use.
•
Patient identification.
•
The date of return of used and unused, expired or malfunctioning investigational
drugs and devices, if applicable.
The Investigator is ultimately responsible for the accountability of all investigational 
products at the site. All used disposable investigational products must be disposed of per 
each site’s SOP. Patients are to follow site-provided waste removal instructions for all 
disposable investigational products used in a patient’s home. Baxter will be accountable
for coordinating the return of supplies (all unused disposables and devices) to the depot 
once the study is complete.
It is prohibited by law to use investigational products outside the intent of this protocol in 
accordance with 21 CFR 312 and 21 CFR 812.

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5.13 Investigational Product Retention
At the end of the study, all devices and unused disposable investigational products at 
investigational sites and patient homes will be returned to Baxter. If needed, the Sponsor
may authorize an alternative disposition of unused products. However, disposition can 
only occur after the Sponsor has been notified and given written authorization. The 
Sponsor will maintain a written record of any authorized disposition of the investigational 
products.
6. STUDY PROCEDURES
6.1 Informed Consent
Prior to collecting any study data, each patient being considered for the study, as well as 
his/her care partners (if participating, see Section 5.4.1), will be provided the most recent 
IRB-approved ICF for review. The PI must ensure that the patient has received all 
relevant information, orally and in writing, relating to the type, objective and possible 
risks and benefits of the study. Patient must also be informed that he/she is free to 
withdraw from the study at any time.
All questions must be answered, and patient must be given enough time to review the ICF
before signing it. The informed consent statement(s) will be reviewed, signed and dated 
by the patient and care partner (if participating) and the person who administered the 
informed consent(s). A copy of the signed ICF will be given to the patient and care
partner (if participating) and the original will be placed in the patient’s medical record. 
Confirmation of a patient’s informed consent must also be documented in the patient’s 
medical records prior to any data collection under this protocol. An IRB approved patient 
ICF will be provided to the PI. The ICF must not be altered without the prior agreement 
of the relevant IRB and Baxter.
Upon signature of the ICF, the study patient will be screened to verify eligibility (see 
Inclusion and Exclusion Criteria in Sections 4.2 and 4.3, respectively). Consented 
patients who have met the study entry criteria will be allowed to continue their 
participation in the study.
If modifications are needed according to local regulations, or if new information becomes 
available (e.g., from Baxter) that can significantly affect a patient’s health and medical 
care, a new version of the patient information and ICF will be prepared in cooperation 
with the PI(s), the IRB and Baxter. Patient and care partner (if participating, see Section 
5.4.1), if still participating in the study must provide written informed consent by signing 
the new ICF and will receive a copy of the signed form and the patient information. A 

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copy of the new version of the form and patient information shall be given to each 
previously enrolled patient for information.
In addition to the ICF (discussed above), each Patient will also be required to consent to 
the Sharesource Patient Notice and Declaration of Consent upon starting-up their AMIA 
APD Solution Generation System.
6.2 Medical History
A complete medical history will include a review of all major body systems and renal 
history (primary etiology of renal disease and PD history including the APD prescription 
per day, history of peritonitis and other disorders or diagnosis). Medication history will 
include all medications being taken 30 days prior to Screening, with each medication 
having a corresponding indication recorded in the Medication History eCRF.
6.3 Physical Examination
A physical examination will be performed at Screening and at the End-of-Study Visit. 
Any change will be noted and recorded on the appropriate eCRF page. These physical 
examinations should not differ from the patient’s usual medical care. An attempt should 
be made to perform a final physical examination on patients who terminate the study 
early, particularly if they are terminating due to an AE.
6.4 Vital Signs
Vital signs (BP and pulse rate) will be recorded on the eCRF at Screening, Study Visit 2, 
Study Visit 3, Study Visit 4, and at the End-of-Study Visit. Weight will be recorded at 
Screening and at the End-of-Study Visit. Blood pressure is to be measured with an 
appropriate cuff size after the patient has been sitting for at least 5 minutes.
6.5 Clinical Laboratory Tests
6.5.1 Laboratory Parameters
Laboratory assessments will occur at Screening and after the patient has been dialyzing 
for at least 4 weeks (occurring one time during Week 5, 6, 7 or 8 of the Study Treatment 
Period), as outlined in Appendix 2. If a patient misses 4 consecutive days of prescribed 
therapy with AMIA APD Solution Generation System then the total Kt/Vurea assessment
(between Weeks 5-8) should be deferred by 1 week to allow a full week of prescribed 
treatment using the AMIA APD Solution Generation System.

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Should a medical emergency arise, a local laboratory may be utilized; however, a copy of 
the laboratory certification, laboratory normal ranges and methodologies will be required. 
A list of laboratory tests is provided in Table 4.
Because of the potential for false-positive beta serum human chorionic gonadotropin 
(β- hCG) test results in females with chronic kidney disease and end stage renal disease, 
both qualitative and quantitative serum pregnancy tests should be taken.
Table 4. List of Laboratory Testsa
Blood
Peritoneal
Urine
β-hCG
Hepatitis B and Hepatitis Cb
CBC with differential
Chemistry Profilec
PD effluent:
WCC with differential
Cell culture
24-hour PD effluent: d
Total Volume
Creatinine
Urea nitrogen 
24-hour urine collectiond
Total volume
Creatinine
Urea nitrogen 
β-hCG = beta serum human chorionic gonadotropin; CBC = complete blood count; PD = peritoneal 
dialysis; WCC = white cell count
a At Screening, chemistry, serology, and hematology tests are completed at a central laboratory. At other 
time points, they are completed at a local laboratory.
b Patients will be screened (those without a history of positive Hepatitis B or Hepatitis C serology) for 
both infections at the Screening Visit. 
-Hepatitis B: Hepatitis B surface antigen (HBsAg) in acute and chronic infection; 
-Hepatitis C: Screening assay (EIA or CIA) for anti-Hepatitis C virus (HCV). 
If positive, automatic verification of positive Screening results by an additional, more specific assay 
(e.g., nucleic acid testing [NAT] for HCV RNA) will be done.
c The chemistry profile includes glucose, calcium, albumin, total protein, sodium, potassium, 
bicarbonate, chloride, creatinine, blood urea nitrogen, alkaline phosphatase, alanine aminotransferase, 
aspartate amino transferase, bilirubin, and phosphorus.
d 24-hour urine (if not anuric) and 24-hour peritoneal effluent collection for total Kt/Vurea will occur one
time during Week 5, 6, 7 or 8 of the Study Treatment Period.
6.5.2 Blood collection
Each patient is to have blood collected at Screening and after he/she has been dialyzing 
with the AMIA APD Solution Generation System for at least 4 weeks (occurring one
time during Week 5, 6, 7 or 8 of the Study Treatment Period).

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6.5.3 24-Hour Urine Collection
Patients who are not anuricc are to collect their 24-hour urine output during the 24 hours
preceding Screening (if Kt/Vurea assessment is not available) and after they have been 
dialyzing with the AMIA APD Solution Generation System for at least 4 weeks 
(assessment done one time during Week 5, 6, 7 or 8 of the Study Treatment Period). If a 
total Kt/Vurea is available from within 45 days of Screening, then it will be used as the 
Screening/Baseline value (i.e., no urine and peritoneal effluent samples will be collected
for the Kt/Vurea calculation).
Patients will be provided with instructions on how to properly collect the sample. They
will be asked to void and discard their urine prior to the 24-hour urine sample collection. 
All urine voided after this time until the following morning at the same time (the exact 
time will be recorded) is to be saved and refrigerated.
6.5.4 Peritoneal Kt/Vurea, Renal Kt/Vurea and Total Kt/Vurea
A total Kt/Vurea assessment is required at Screening and will also serve as the Baseline 
value. However, if a total Kt/Vurea is available from within 45 days of Screening, then it 
will be used as the Screening/Baseline value (i.e., no urine and peritoneal effluent 
samples will be collected at Screening for the Kt/Vurea calculation). Weekly Peritoneal 
Kt/Vurea will be calculated from blood and 24-hour PD effluent samples collected and 
renal Kt/Vurea will be calculated from 24-hour collection of urine samples (if applicable) 
and blood samples after the patient has been dialyzing with the AMIA APD Solution 
Generation System for at least 4 weeks (assessment done one time during Week 5, 6, 7 or 
8 of the Study Treatment Period). Total Kt/Vurea is the sum of peritoneal Kt/Vurea and 
renal Kt/Vurea. Formulas to calculate Total Kt/Vurea are provided in Appendix 4.
6.5.5 White Cell Count and Cell Culture
Peritoneal effluent must be obtained at Screening to assess WCC with differential and 
cell culture. If PD effluent is collected at Screening to calculate Weekly Peritoneal 
Kt/Vurea then the same effluent may be used for assessing WCC with differential and cell 
culture.
                                                
c Anuria is defined in the adult population as a passage of <50 mL of urine per day.

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6.5.6 Sample Collection, Storage, and Shipping
A study specific Laboratory Manual will be provided from each of the central 
laboratories to the PI and will include detailed instructions on the collection, preparation, 
storage, and shipping procedures for study samples and the appropriate laboratory ranges. 
Collection of 24-hour PD effluent samples will be made using the batch method. All 
laboratory samples will be collected, stored, shipped and processed by the laboratories 
according to each central lab’s procedures.
6.5.7 Simulated Treatments
For simulated treatments, patients will set up the system as they would for a study 
treatment, but will not connect the patient line or use the generated solution for treatment. 
During the monthly simulated treatment, the prescriptions will be manipulated to ensure 
that the patient produce all three glucose concentrations of the Dianeal Low Calcium PD 
solutions at different time points for testing. Samples will be collected by the clinic nurse 
or designee and the disposable set will no longer be usable. The simulated treatment will 
be ended with no treatment performed on the patient and the patient will then remove the 
remaining components of the disposable set from the system.
6.5.8 Water and Dialysate Sampling Analysis 
Feed water used to supply the WD will be collected by Baxter personnel and sent for 
analysis during the home assessment process and again at the de-installation visit. Feed 
water shall not exceed the chemical or biological contaminant levels as stated in the 
AMIA APD Solution Generation System feed water specification and Feed Water 
Sampling at Installation for PoC APD.10,11 The product water from the WD (pre-
sterilizing filters) shall conform to ISO 139591 for microbiological (including endotoxin) 
and chemical contamination, and the water in the holding bag (post-sterilizing filters)
shall not exceed 0 CFU/mL for bacteria (no growth) and be < 0.03 EU/mL for 
endotoxins, consistent with Dianeal specifications for sterility. Product water shall not 
exceed the nitrate contamination limit of 2 mg/L. Sampling for product water testing for 
microbiological and chemical contamination may be done on different days within the 
allocated window.
The Sponsor or its designee will train the site nurses responsible for collecting the water 
and dialysate samples during the study. Instructions will be provided in the study training 
materials. Standardized recovery methods and controls will be incorporated into the 
testing protocol(s). Central laboratories will be used for all water and dialysate testing.

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Sample results will be sent to the study sites and Sponsor for real time review and action 
(if appropriate). Observations and decisions regarding corrective measures (e.g., re-
culture and/or disinfection of the WD) will be based on the organism growing and on 
whether bacterial or endotoxin levels exceed the specified guidelines. An internal 
Sponsor Committee will also review study wide results on a bi-weekly basis, at a 
minimum, to search for trends and to action appropriately.
Analysis of water will be performed on samples obtained as follows.
6.5.8.1 Chemical Contaminants
Feed Water
Samples of feed water will be collected by Baxter personnel or designees and tested for 
chemical contaminants from each study site during site feasibility, prior to AMIA APD 
Solution Generation System installations at the site, according to limits stated in the 
AMIA APD Solution Generation System feed water specification.10 Samples will also be 
collected from feed water at patients’ homes during home assessments while consented 
patients are in the Screening Period and at de-installation.
AMIA APD Solution Generation System Product Water
Samples of product water from the WD (pre-sterilizing filters) will be collected from 
each device by Baxter personnel or designees at installation at the patients’ homes, and 
tested for chemical contaminants. Product water will be tested according to ISO 13959 
which includes testing for nitrate contamination, and the <2 mg/L limit of nitrates will be 
confirmed. These samples from the AMIA APD Solution Generation System will be 
collected at the water line port. Patients cannot treat on the AMIA APD Solution 
Generation System in the home until the post-installation product water results are 
received and reviewed by the study site and Sponsor per the AMIA APD Solution 
Generation System Patient Guide. The sample will be collected in conjunction with Study 
Visit 1 and during Study Treatment Weeks 4, 8 and 12.
6.5.8.2 Microbiological Cultures and Endotoxin – Product Water and Water from 
Holding Bag
Samples of AMIA APD Solution Generation System water (product water) will be 
collected from the system by Baxter personnel or designees at installation at the patients’ 
homes and at timepoints designated in the protocol (Study Treatment Weeks 1 [Study 
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the WD (pre-sterilizing filters) will be collected and tested for microbiological (including 
endotoxin) contamination per USP <61> and USP <85>.
Patients will generate water in the holding bag using the AMIA APD Solution Generation 
System during a simulated treatment in their home at timepoints designated in the 
protocol (Study Treatment Weeks 1 [Study Visit 1], 4 [Study Visit 2], 8 [Study Visit 3] 
and 12 [Study Visit 4]). Water in the holding bag will be collected and tested for 
microbiological contamination and endotoxin levels per USP <71> and USP <85>. Water 
in the holding bag (post-sterilizing filters) shall not exceed 0 CFU/mL for bacteria (no 
growth) and shall be < 0.03 EU/mL for endotoxins, consistent with Dianeal specifications 
for sterility.
All samples will be collected and packaged using aseptic techniques and sent to the 
central lab for analysis. Patients cannot treat on the AMIA APD Solution Generation 
System in the home until the post-installation product water results are received and 
reviewed by the study site and Sponsor per the AMIA APD Solution Generation System 
Patient Guide.
6.5.8.3 Dialysate Composition Testing
Patients will generate dialysis solution using the AMIA APD Solution Generation System 
during a simulated treatment in their home at timepoints designated in the protocol 
(Study Treatment Weeks 1 [Study Visit 1], 4 [Study Visit 2], 8 [Study Visit 3] and 12 
[Study Visit 4]). The heater bag containing the dialysis solution generated by the 
simulated treatment will be collected by Baxter personnel or designee and shipped to a 
central laboratory for analysis of chemical composition.
6.5.8.4 Additional Sampling Procedures
The dual in-line sterilizing grade filters will be collected during sample collection 
procedures at each simulated treatment. The filters will be returned to Baxter R&D for 
possible investigation and used as an investigatory tool in the event of a positive finding 
from endotoxin or microbiological contamination in the holding bag.
6.5.8.5 Process for Responding to Out-of-Specification Results
6.5.8.5.1 Decision Trees
Clinical study decision trees for feed water12, product water (pre-sterilizing filters)13,
water from the holding bag (post-sterilizing filters)14, and dialysis solution samples15
have been developed and will be included in training materials and provided to study 
sites. These decision trees provide guidance to the clinical site and the Baxter team on 

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appropriate actions to be taken in situations where out of specification (OOS) results are 
received from the samples. Decision trees are structured to ensure patient safety. If test 
results are out of specification, the decision trees provide a mechanism for removing
affected patient(s) from therapy if any safety concerns arise as determined by a clinician 
and/or the study team.
Upon confirmation of an OOS value for endotoxin or bacteria, a root cause investigation 
will be initiated, specific components of the AMIA APD Solution Generation System
may be changed, and the replaced components may be sent to Baxter for functional 
assessment.
Additional actions may include:
•
Resample.
•
All device logs evaluated for anomalies.
•
Aseptic procedure checklists recorded during sample collection and processing 
reviewed for anomalies.
•
The Contract Laboratory will conduct an independent investigation of their 
procedures and processes for any OOS endotoxin or micro-organism result.
Consideration for additional actions such as retrieval and analysis of hardware and/or 
disposables, on site investigation for additional machine and environmental cultures.
6.5.8.6 Chlorine and Conductivity Testing
Chlorine testing of the water will be performed prior to each dialysis treatment. Water for 
chlorine testing is collected from the Water Sample Outlet and tested as specified in the 
AMIA APD Solution Generation System Patient Guide.16 Stricter local regulations for 
testing will be utilized if required.
Conductivity testing of the dialysate is performed by the AMIA APD Solution 
Generation System after each heater bag replenish prior to delivering fluid from that 
replenish to the patient without input from the user. If the conductivity test shows the 
dialysate is not within specification, the AMIA Solution Generation System will empty 
the heater bag and perform a new replenish. The system will warn the user if a 
conductivity issue is noted and user action is required.
Chlorine and conductivity testing are conducted as part of normal operation of the system
to ensure device reliability. These results are captured in device logs and are not included 

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in study endpoints or any planned statistical analysis. Independent chlorine testing is 
included in the monthly product water testing and compliance of the conductivity of the
solution is monitored through the heater bag dialysis solution testing.
6.6 Power Outage
If the WD is off due to a power outage for more than 3 consecutive days during the use of 
the AMIA APD Solution Generation System, Baxter Technical Services must restore the 
WD to operating conditions before the patient can use the AMIA APD Solution 
Generation System for treatment. When not in use, the WD must be plugged in and 
turned on. The water supply to the WD and the patient’s home must remain on and 
connected to the drain.
6.7 Boil Water Advisory Procedure
If a municipal water supplier issues a “boil water advisory” for the feed water at a 
patient’s location, the patient should discontinue use of the study generated PD solution
and commence APD therapy using approved Dianeal Low Calcium (2.5 mEq/L) PD 
Solution bags or prior solution as assessed by the Investigator. Patients will be 
discontinued from the study following a boil water advisory affecting the feed water in 
their home.
6.8 Removal of Patients from the Study
Patients are considered withdrawn / prematurely discontinued from the study if their 
participation is stopped before completion of the required evaluations as described in this 
protocol (see Section 3.5.1). If a patient is prematurely removed from the study, all data 
prior to discontinuation should be recorded in the eCRF and all available data will be 
included in all analyses.
The Investigator may terminate a patient’s study participation at any time during the 
study if he/ she judges it to be in the patient’s best interest. If a patient is withdrawn from 
the study, the Clinical Study Manager or Monitors should be informed at the earliest 
possible opportunity, regardless of the reason(s) for withdrawal. In addition, a patient 
may discontinue his or her participation at any time during the study without having to 
justify the decision. If a patient’s participation is discontinued, the reason(s) must be 
recorded in the source documents and on the eCRF. If a patient discontinues for any 
reason, every effort should be made to perform all of the procedures that are scheduled 
for the End-of-Study/ Early Termination Visit. In addition, SAEs, related or not and 
ADEs, will be followed post-study according to the safety plan.

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6.9 Other Study Procedures
•
Comprehension and retention testing (materials provided by Baxter) for patient 
and/or care partner (if participating) will occur at the end of the Baseline Period 
(In-center Training Period). If the patient does not read and understand English, 
the care partner will assist the patient with comprehension and retention testing.
The Investigator or a designee must also reassess the stability of the patient during 
the Baseline Period (In-center Training Period). Once the clinician concludes that 
the patient is clinically stable and his/her PD prescription is stable, then the 
patient can begin treatment in the home.
•
Home installation will occur during the Screening or the Baseline Period (In-
center Training Period).
•
The patient will conduct chlorine testing prior to every treatment.
•
Additional testing and procedures will be performed per local standard of care.
6.10 Appropriateness of Measurements
Measurements for the primary and secondary endpoints are well accepted. Other 
chemistry and hematology measurements to evaluate safety are standard for the 
indication or patient population being studied.
7. DATA COLLECTION FOR SAFETY ASSESSMENTS AND REPORTING
7.1 Definition of Adverse Events and Device Deficiencies
Table 5. Adverse Event Term Definition
Term
Definition
Adverse Event (AE)
Any untoward medical occurrence in a patient or clinical investigation 
subject administered a product which does not necessarily have a causal 
relationship with this treatment.
Adverse Drug Reaction 
(ADR) or Adverse 
Reaction (AR) /Adverse 
Device Effect (ADE)
Adverse event related to the use of study product.
Suspected Adverse 
Reaction (SAR)
Any AE for which there is a reasonable possibility that the product caused 
the AE. For the purposes of IND safety reporting “reasonable possibility” 
means there is evidence to suggest a causal relationship between the product 
and the AE.
Unexpected Adverse 
Drug Reaction (UADR)
An adverse reaction in which the nature or severity is not consistent with the 
applicable product information (e.g., Investigator’s Brochure for unapproved 

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Table 5. Adverse Event Term Definition
Term
Definition
investigational product or package insert/summary of product characteristics 
for an approved product). (ICH E6 (R2))
The Adverse reaction may not be listed at the specificity or severity that has 
been observed; or if an investigator brochure is not required or available, is 
not consistent with the risk information described in the general 
investigational plan or elsewhere in the current application, as amended. (21 
CFR 312.32)
Adverse Event of Special 
Interest (AESI)
An adverse event of special interest (serious or non-serious) is one of 
scientific and medical concern specific to the Sponsor’s product or program, 
for which ongoing monitoring and rapid communication by the investigator 
to the Sponsor can be appropriate. Such an event might warrant further 
investigation in order to characterize and understand it. Depending on the 
nature of the event, rapid communication by the study Sponsor to other 
parties (e.g., regulators) might also be warranted. (FDA Guidance for 
Industry E2F).
Serious Adverse Event 
(SAE) or Serious 
Adverse Drug Reaction 
(SADR) or Serious 
Adverse Device Effect 
(SADE)
Any untoward medical occurrence that at any dose:
•
Results in death (including fetal death).
•
Is life-threatening.
•
Requires inpatient hospitalization or results in prolongation of 
existing hospitalization.
•
Results in persistent or significant disability/incapacity.
•
Is a congenital anomaly/birth defect (ICH E6 (R2)).
•
Is a medically important event or reaction that may not be 
immediately life-threatening or result in death or hospitalization, but 
may jeopardize the patient or requires intervention to prevent one of 
the other outcomes listed above.
Device Deficiency (DD)
Inadequacy of an (investigational) medical device related to its identity, 
quality, durability, reliability, safety or performance, such as malfunction, 
misuse or use error and inadequate labeling.
This includes DDs that might have led to an SAE if:
•
Suitable action had not been taken or
•
Intervention had not been made or
•
If circumstances had been less fortunate.
Suspected Unexpected 
Serious Adverse 
Reaction (SUSAR) 
/Unanticipated Adverse 
Device Effect (UADE)
An AE that in the view of the Investigator or Sponsor, meets the definition 
of serious, unexpected, and is suspected to have a causal relationship to 
study product. Suspected Unexpected Serious Adverse Reactions are also 
reportable for active comparator products, placebo, or the clinical study 
protocol itself (i.e., events due to study procedures).
Any SADE on health or safety or any life-threatening problem or death 
caused by, or associated with, a device, if that effect, problem, or death was 
not previously identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of patients.

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Table 6. Definition of Terms
Term
Definition
Awareness Date or 
Baxter Awareness Date 
(BAD)
The date on which any Baxter employee or their agent becomes aware of an 
adverse event (AE). This date is considered Day 0 on the regulatory reporting 
time clock.
Date of Onset
The date when the signs and symptoms of the AE begin.
Investigational Product 
(IP)
Experimental product under study or development. This term is more specific 
than investigational medicinal product, which includes comparators and 
placebos. For this protocol, the term “investigational drug” is synonymous 
with “investigational product”.
For this protocol, the term “investigational product” is synonymous with 
AMIA APD Solution Generation System.
Diagnosis vs 
Complications
A patient experiences not only a diagnosis, but also additionally a 
complication of the diagnosis (i.e., myocardial infarction with congestive 
heart failure); both the diagnosis and the medical complication should be 
collected and recorded as separate AEs.
7.2 Safety Reporting
All AEs, PCs and DDs observed by the study personnel or reported by the patient during 
the course of the study will be documented from the time of signing the ICF through the 
End-of-Study/ Early Termination Visit.
Any medical condition, that is present at the time that the participant is screened, will be 
considered medical history and not reported as an AE (see Appendix 6). Any medical 
event that is commonly associated with a study participant’s PD therapy will be 
considered medical history and not reported as an AE (see Appendix 6). However, if the 
study patient’s condition/event worsens (change in severity or frequency) at any time 
during the study, it will be recorded as an AE.
If a definitive diagnosis has been medically established by the physician caring for the 
patient or by the Investigator, this diagnosis should then be recorded as the AE on the 
eCRF and the signs and symptoms removed. If a definitive diagnosis has not been 
medically established, the signs and symptoms should then be recorded as the AEs.
Adverse events that change in severity will be reported at each incidence, but 
documented only once in the eCRF with the highest degree of severity.

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An elective procedure/ surgery that occurs during the course of a study, but is being 
performed for a documented pre-existing condition and was pre-planned prior to study 
entry will not qualify as an AE. If, however, the pre-existing condition unexpectedly 
deteriorates during the study requiring the procedure/ surgery to be performed earlier than 
planned, the condition for which the procedure/ surgery is being performed will qualify 
as an AE.
Laboratory and vital sign abnormalities qualify as AEs if medical intervention is required 
to treat or address the abnormality, if the patient must be discontinued from the study due 
to the abnormality, or if the Investigator determines the value is clinically significant.
An AE can result from the use of the study product in accordance with the protocol, as 
well as from an accidental or intentional misuse of the study product or any other 
treatment error such as unintentional administration or use of another product during the 
course of the study.
If an AE or DD occurs, a full description of the event should be recorded including the 
date and time of onset, as well as outcome, seriousness, severity, event description, 
actions taken, and causal relationship of the AE. Investigators should review and 
reference the causality (see Table 7) and severity definitions (see Table 8) when 
determining relationship of the AE to the study product or typical PD therapy. The 
Investigators may also discuss the event(s) with the Baxter Medical Monitor or designee.
All AEs should be actively solicited and documented in the eCRFs, no matter how 
common they are for a particular patient and regardless of the causality assigned by the 
Investigator. Additionally, any AE voluntarily reported by the patient should be recorded 
and verified by the Investigator or a designee with the relevant source documents and 
eCRF. Each SAE will be documented on a separate SAE report form. 
The outcome/ resolution of all AEs will be determined by the Investigator and 
documented in the AE eCRF. Investigators will be instructed to follow all treatment 
emergent AEs as follows: Adverse device effects (related AEs) and all SAEs (related or 
not) will be followed until resolution or stable, including following the patient after the 
end of the study if necessary.
For the outcome conclusions that can be used on the eCRF by the Investigator, refer to
Table 9.

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If a patient in this study also receives a Baxter medicinal/ drug product which is part of a 
patient’s normal treatment (not an investigational product or comparator), any AE which 
is considered causally related to the medicinal/ drug product by either the Investigator or 
the medical monitor shall be forwarded by the Investigator or a designee within 24 hours
of becoming aware of the AE to Baxter Global Patient Safety
(
 for assessment as per Baxter’s 
process for case processing of spontaneous reports.
Causality is a determination of whether there is a reasonable possibility that the study 
product is etiologically related to/ associated with an AE. Causality assessment includes, 
for example, assessment of temporal relationships, dechallenge/rechallenge information, 
association (or lack thereof) with underlying disease, presence (or absence) of a more 
likely cause, and physiologic plausibility.
Table 7. Causality Assessments
Classification
Causality Criteria
Causal Association
Probably 
Associated
•
An AE that follows a strong temporal relationship to the 
administration/use of the study product and/or recurs on 
rechallenge.
•
Results in a positive sensitivity test.
•
Unlikely to be attributed to disease, procedure or other 
drugs/devices.
•
An AE improves with withdrawal of the product.
Yes
Possibly 
Associated
•
An AE follows a reasonable temporal relationship to the 
administration/use of the study product.
•
An alternative etiology is equal or less likely.
Yes
Unlikely 
Associated
•
An AE has little or no temporal relationship to the 
administration/use of the study product.
•
An alternative etiology is more likely.
No
Not 
Associated
•
An AE that is due to underlying or concurrent illness, 
complications, concurrent treatments or effect of another 
concurrent device/drug and is not associated to the 
device/drug, that is, does not follow a reasonable 
temporal relationship to administration/use of the study 
product.
•
Has a much more likely alternative etiology.
No

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Table 8. Severity Assessments
Criterion
Definition
Mild
Is a transient discomfort and does not interfere in a significant manner with the patient’s 
normal functioning level. The AE resolves spontaneously or may require minimal 
therapeutic intervention.
Moderate
Produces limited impairment of function and can require therapeutic intervention, but 
produces no sequelae.
Severe
Results in a marked impairment of function and can lead to temporary inability to 
resume usual life pattern. The AE produces sequelae requiring (prolonged) therapeutic 
intervention.
Table 9. Outcome Conclusion Criteria
Fatal
Not recovered/Not resolved/Permanent:
This outcome is reached for AEs which are ongoing when the patient’s end of study is due to death 
related to another AE
Recovering/Resolving:
This outcome is reached for AEs which are ongoing at the patient’s end of study
Recovered/Resolved with Sequelae:
If there are some residual effects caused by the event
Recovered/Resolved
Unknown
7.2.1 Adverse Event of Special Interest
Adverse events of special interest are listed below. The adverse events within this section 
represent those that are thought to have an association with the use of the AMIA APD 
Solution Generation System or in conjunction with performing the peritoneal dialysis 
procedure.
•
Aseptic Peritonitis
•
Hypovolemia
•
Hypokalemia
•
Hyponatremia
•
Encapsulating Peritoneal Sclerosis
•
Medication Error: administration of incorrect glucose concentration
•
Lactic Acidosis

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•
Hyperglycemia
•
Hypocalcemia
The definitions of AESIs are provided in Appendix 5.
7.2.2 Medical Events Commonly Associated with Peritoneal Dialysis
The medical events and their definitions, that have been commonly reported as possibly 
related to PD therapy in general, are provided in Appendix 6. This list has been provided 
to ensure these events are captured in the patients’ medical history, when appropriate. If 
an event is part of the patient’s medical history, it will not be considered as an AE for the 
study unless the frequency increases or the severity worsens.
7.2.3 Adverse Events Reporting
The PI shall:
•
Record every AE with a full description.
•
Follow-up or new information about an SAE should be provided by the 
Investigator or a designee using the SAE form within 24 hours of becoming aware 
of the new information.
•
All non-serious AEs that are upgraded to an SAE should be forwarded to Baxter 
or designee within 24 hours.
•
Supply Baxter or designee, upon Baxter’s or designee’s request, with any 
additional information related to the safety reporting of a particular event.
•
Report any SAE if becoming aware after study completion has occurred in a 
patient during their participation in the study, the SAE must be reported on the 
SAE Form within 24 hours of awareness.
•
If an event is part of the patient’s medical history, it will not be considered as an
AE for the study unless the frequency increases or the severity worsens.
7.3 Product Complaints
A product complaint is any written, electronic, or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, usability, safety, 
effectiveness, or performance of a product after it is released for distribution or related to 
a service that affects the performance of such product. A complaint may involve the 
possible failure of the product itself, its packaging, or its labeling (i.e., product label, 

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package insert, or any instructions for use). The complaint need not be confirmed by the 
manufacturer to be considered a complaint. Any product complaints identified by the 
investigator will be reported to Baxter using a paper Product Complaint/Non-Medical 
Complaint Form.
7.4 Medical Monitor
The medical monitor will regularly review data collected from eCRFs, and laboratory 
data for potential safety concerns. This review plan will be documented in a study Safety 
Management Plan.
Periodic review of reported AEs will be completed by Baxter or designee. At the site 
level the Investigator must assess risk and clinical significance of events to each 
individual study patient, including removing the patient from the study if necessary.
7.5 Safety Reporting to Authorities and Institutional Review Board
It is the responsibility of the Investigator to report any SAEs to IRB according to local 
regulatory requirements
Baxter or designee will assess each SAE reported by the Investigator to determine if the 
event qualifies as an Expedited Report according to local regulations. Expedited reports 
will be submitted to the appropriate Authority by Baxter or designee. Per regulations, 
Investigators will receive a letter from Baxter or designee describing the expedited SAE. 
The Investigator should file this letter within their Investigator Site File. Additionally, the 
Expedited Report letter may need to be submitted by the Investigator to their IRB, as 
appropriate per local regulations.
7.6 Pregnancy Reporting 
If a female study patient or a study patient’s partner becomes pregnant during the study 
patient’s participation in the trial, the pregnancy must be reported to the Sponsor by 
providing a completed Pregnancy Report Form and Pregnancy Follow-up Form to Baxter 
Global Patient Safety (
.
8. STUDY ACTIVITIES
8.1 Schedule of Evaluations and Procedures
All clinical study evaluations will be performed according to Appendix 1 and the 
instructions listed below. If a patient discontinues from the study prematurely, every 
attempt will be made to perform all of the procedures and evaluations that are scheduled 
for the final visit (i.e., End-of-Study/ Early Termination Visit).

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8.2 Screening Period (approximately 3 weeks)
Consented patients who have met the study entry criteria will be allowed to continue their 
participation in the study and will undergo the Screening assessments and home 
evaluation.
The following procedures should be completed during the Screening Period:
1. Patients and care partners (if participating) (See Section 5.4.1) sign the ICF on the 
first day of the Screening Period.
2. Record patient medical history (PD history including the APD prescription per 
day, history of peritonitis and other disorders or diagnosis). Medical history will 
also include demographics (age, gender, race, height, weight, body mass index 
calculated as weight (kg)/height2 (m), and ethnicity) and prior medications (all 
medications being taken at the time of Screening and 30 days prior to Screening, 
with each medication having a corresponding indication recorded on the Medical 
History eCRF form).
3. Physical examination including weight and height.
4. The date of the last total Kt/Vurea calculation should be noted (if a total Kt/Vurea is 
available from within 45 days of Screening, then it will be used as the 
Screening/Baseline value [i.e., no urine and peritoneal effluent samples will be 
collected for total Kt/Vurea]).
5. Clinical laboratory evaluations as outlined in Appendix 2.
6. Vital signs including BP, pulse rate and temperature.
7. Home suitability assessment.
8. Feed water analysis for the home.
9. Home Installation, when suitable.
10. The PI or designee will assess each patient at the Screening visit and on a weekly 
basis, according to standard of care. At a minimum, this assessment will include 
evaluation of BP, pulse rate, weight, fluid status and dialysis prescription.
11. Collection of concomitant medication information.
12. Collection of AEs/ SAEs.
13. The Investigator must assess the stability of the patient (Clinical and prescription 
stability).

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14. If the patient is a screen failure, the reason for their failure must be recorded. Any 
patient who withdraws from the study before installation of the device is 
considered a screen failure. In addition, any patient who withdraws from the study 
after the installation but before confirming that all the inclusion criteria and none 
of the exclusion criteria are met, and withdraws due to a non-device related issue, 
is also considered a screen failure.
8.3 Training for PD Home Solution Generation System
Study personnel performing training with the AMIA APD Solution Generation System 
for this clinical study will be comprised of physicians, PD nurses and other clinicians. 
Study staff will be trained on the use of the AMIA APD Solution Generation System by 
the Sponsor’s representative prior to patient enrollment. Training dates and training 
material, provided by Baxter, will be documented and filed in the Investigator Site File.
8.4 Baseline Period (In-center Training Period)
The Baseline Period (In-center Training Period) will begin immediately following the 
Screening Period, will include in-center training, and will last for approximately 2 weeks.
The following information will be collected and procedures or evaluations will be 
performed:
1. Baseline Assessments
-
Assessment by an Investigator or a designee. At a minimum, this assessment 
will include evaluation of BP, pulse rate, weight, fluid status and dialysis 
prescription.
-
Collection of concomitant medication information.
-
Collection of AEs/ SAEs.
2. Installation of the AMIA APD Solution Generation System in the patient’s home
(if not yet performed).
3. AMIA APD Solution Generation System specific device training and general 
therapy training for the patient and care partner (if participating) (See Section
5.4.1).
4. Machine information including the available code number(s) and a lot/serial 
number(s) at initial installation and if the device or any of the disposables are 
changed.

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5. Baseline Period (In-center Training Period) will conclude with:
-
Successful comprehension and retention testing, provided by Baxter, for the 
patient and/or care partner (if participating). If the patient does not read and 
understand English, the care partner will assist the patient with comprehension 
and retention testing.
-
The Investigator must reassess the stability of the patient during the Baseline 
Period (In-center Training Period). Once the clinician concludes that the 
patient is clinically stable and their PD prescription is stable, then the patient 
can begin treatment in the home.
-
Written confirmation of independent care by patient and care partner (if 
participating).
8.5 Each Treatment Day
Patients will set up and complete a treatment using the AMIA APD Solution Generation 
System according to their prescribed dialysis regimen.
The following assessments will be completed each day throughout the Study Treatment 
Period.
1. Collection of concomitant medication information.
2. Weight pre- and post-dialysis.
3. Vital signs, before and after each treatment, including seated BP, pulse rate and 
temperature.
4. Collection of AEs/ SAEs.
5. Collection of ADEs and SADEs once the patient is connected to the AMIA APD 
Solution Generation System.
6. Collection of AMIA APD Solution Generation System-related PCs/ DDs, which 
would include functional characteristics (e.g., particulate matter, PD fluid 
discoloration, leaks, tubing separations), will begin from the time of signing 
informed consent and will continue throughout the entire Study Treatment Period.
7. Collection of machine information.
8. Collection of machine observations.
9. Chlorine testing performed by patients before each treatment.

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10. Collection of diary source data (eDiary).
8.6 Simulated Treatment Visit 1 (Before 1st Treatment in the Home, Study Visit 1)
The following assessments will be completed during Simulated Treatment Visit 1, Study 
Visit 1.
1. A simulated treatment will be set up by the patient. The dialysis solution 
generated during simulated treatment will be collected by the clinic nurse or 
designee from the system in the heater bag and used to evaluate the chemical 
composition of the final dialysis solution produced by patients using the AMIA 
APD Solution Generation System compared to the specifications of Baxter’s 
approved Dianeal Low Calcium (2.5 mEq/L) PD Solution.
2. Product water from the WD (pre-sterilizing filters) will also be collected by a 
clinic nurse or designee and will be tested to confirm that it conforms to ISO 
standard 139591 for microbiological (including endotoxin) and chemical 
contamination. Collecting a product water sample involves connecting a container 
and/ or tubing to the WD and obtaining a sample volume of water from the WD 
for microbiological and chemical testing. This procedure cannot be performed 
using the disposable set required for actual treatment setup, since the sterilizing-
grade filters will remove additional microbial contamination. The purpose of this 
procedure is to demonstrate that the WD is functioning appropriately in the 
patient’s home, and since sampling is not dependent upon the user performing the 
procedure, patients do not have to perform it for the study (decreasing the impact 
on patients/ nurses).
3. Water from the holding bag (post-sterilizing filters), generated during a simulated 
treatment will be collected and tested to confirm it does not exceed 0 CFU/mL for 
bacteria (no growth) and is < 0.03 EU/mL for endotoxins, consistent with Dianeal 
specifications for sterility. Simulated treatment is prepared by the patient, in the 
same manner in which actual treatment is prepared (using the disposable set, 
filters, etc.) Due to the risk of contamination, the holding bag cannot be 
compromised, particularly since the water needs to be sterile. The purpose of this 
procedure is to demonstrate that the system functions as intended when used by 
patients under real-world conditions.
4. Assessment by an Investigator or a designee.

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5. Collection of AEs/ SAEs.
6. Collection of AMIA APD Solution Generation System-related PCs and DDs.
8.7 Study Visits 2, 3 and 4 (Study Treatment Weeks 4, 8 and 12)
Study Visits 2, 3 and 4 will occur during Study Treatment Weeks 4, 8 and 12 of the Study 
Treatment Period, respectively. In addition to the assessments included in Section 8.5, the 
following assessments will be completed during Study Visits 2, 3 and 4.
1. A simulated treatment will be set up by the patient. The dialysis solution 
generated during simulated treatment will be collected by the clinic nurse or 
designee from the system in the heater bag and used to evaluate the chemical 
composition of the final dialysis solution produced by patients using the AMIA 
APD Solution Generation System compared to the specifications of Baxter’s 
approved Dianeal Low Calcium (2.5 mEq/L) PD Solution.
2. Product water from the WD (pre-sterilizing filters) will be also be collected by a 
clinic nurse or designee and tested to confirm that it conforms to ISO standard 
139591 for microbiological (including endotoxin) and chemical contamination,
and water from the holding bag (post-sterilizing filters), generated during a 
simulated treatment, will be collected and tested to confirm it does not exceed 
0 CFU/mL for bacteria (no growth) and is < 0.03 EU/mL for endotoxins, 
consistent with Dianeal specifications for sterility. For more information 
regarding the differences in simulated treatment testing for product water from the 
WD and for product water from the holding bag, refer to points 2 and 3 in 
Section 8.6.
3. Assessment by an Investigator or a designee.
After the final Study Treatment Visit, patients are to transition back to treatments with 
AMIA with Baxter’s approved Dianeal Low Calcium (2.5 mEq/L) PD Solution in their 
home environment and enter a 5-10 day Follow-up Period. Return of all investigational 
products and study related supplies will be scheduled during this time.
8.8 Total Kt/Vurea Visit
A visit to assess total Kt/Vurea will occur after the patient has been dialyzing with the 
AMIA APD Solution Generation System for at least 4 weeks (assessment done one time
during Week 5, 6, 7 or 8 of the Study Treatment Period). The patient will collect 24-hr 

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PD effluent and 24-hr urine prior to the visit by a clinic nurse or designee who will then 
collect these samples and a blood sample for analysis.
Refer to Sections 6.5.2, 6.5.3, and 6.5.4 for instructions for this assessment.
Clinical laboratory evaluations as outlined in Appendix 2.
8.9 Follow-up Period
After the last study treatment with AMIA APD Solution Generation System, patients will
transition back to Standard AMIA treatment with Baxter’s approved Dianeal Low 
Calcium (2.5 mEq/L) PD Solution and enter a Follow-up Period of 5-10 days. During this 
time, an assessment by an Investigator or a designee will occur. At a minimum, this 
assessment will include evaluation of BP, pulse rate, weight, fluid status and dialysis 
prescription. Adverse events, SAEs, ADEs and SADEs will be collected throughout the 
Follow-up Period and through the End-of-Study/ Early Termination Visit.
8.10 End of Study Visit or Early Termination Procedures
The End of Study assessments will be performed 5-10 days after the last treatment with 
the AMIA APD Solution Generation System (i.e., at week 13 for patients who completed 
the 12 weeks of treatment). If a patient discontinues from the study prematurely, every 
attempt should be made to perform all procedures and evaluations that are scheduled for 
the End of Study/ Early Termination Visit. A patient who withdraws from the study after 
installation and after meeting all the inclusion criteria and none of the exclusion criteria is 
considered an Early Termination patient. In addition, a patient who withdraws from the 
study after installation but before confirming that all the inclusion criteria and none of
exclusion criteria are met and withdraws due to a device-related issue (e.g., leaking, 
alarms, etc.), is also considered an Early Termination patient.
The following data will be collected:
1. Collection of AEs/ SAEs.
2. Adverse events of special interest (Refer to Section 7.2.1 for the full list of 
AESIs).
3. Physical examination including weight.
4. Assessment by an Investigator or a designee.
5. Vital Signs.

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9. DATA MANAGEMENT, QUALITY CONTROL AND QUALITY ASSURANCE
The Sponsor is responsible for implementing and maintaining quality assurance and 
quality control systems with written SOPs to ensure that studies are conducted and that 
the data are generated, documented and reported in compliance with the protocol and 
applicable regulatory requirements. Quality control will be applied to all stages of data 
handling to ensure reliability and correct processing. The Sponsor is responsible for 
securing agreement from all involved parties to ensure direct access to all study related 
centers, source documents and reports for the purpose of monitoring and auditing. 
Agreements made with the Investigator/ institution will be in writing.
9.1 Auditing
The Sponsor and/ or Sponsor’s representatives may conduct audits to evaluate study 
conduct and compliance with the protocol, standard operating procedures, other written 
instructions/agreements, ICH GCP, the IRB and applicable regulatory guidelines/
requirements. The Investigator will permit auditors to visit the study site, as described in 
the Clinical Study Agreement. Auditing processes specific to the study will be described 
in the auditing plan.
9.2 Non-compliance with the Protocol
The Investigator will not deviate from this protocol without prior documented approval 
from the Sponsor and the IRB, except in cases of medical emergency. The Investigator
may deviate from the protocol without prior approval only when the change is necessary 
to eliminate an apparent immediate hazard to the patient. In that event, the Investigator
will notify the Sponsor immediately by phone, notify the IRB and confirm notification to 
the Sponsor in writing as soon as possible, but within five (5) working days after the 
change is implemented.
A protocol deviation is any noncompliance with the clinical study protocol, study-related 
procedures, or ICH GCP requirements. The noncompliance may be either on the part of 
the participant, the Investigator, or the study site staff. As a result of deviations, 
corrective actions are to be developed by the site and implemented promptly.
Protocol violations/ deviations will be documented in source documents and in the 
Investigator’s research study files as applicable. Protocol violations/ deviation waivers 
will not be issued. The clinical team will review deviations at a study level on a regular 
basis, as detailed in the Clinical Operations/Monitoring Plans.

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10. PLANNED STATISTICAL METHODS
10.1 General Considerations
Further details of the planned statistical methods will be provided in the study SAP. The 
SAP will be finalized prior to database lock. Any changes to the statistical methods 
described in the protocol will be documented in the SAP.
Unless otherwise noted, all analyses will be performed using SAS/GRAPH® 9.4 
software, SAS/STAT® 14.1 software and Base SAS® 9.4. Copyright© 2002-2012, SAS 
Institute Inc. SAS and all other SAS Institute Inc. product or service names are registered 
trademarks or trademarks of SAS Institute Inc., Cary, NC, USA. All Rights Reserved.4
Summary statistics will be presented with mean, standard deviation, median, minimum 
and maximum for continuous variables and frequency count and percentage based on 
study population will be used to summarize categorical variables. Prior to analysis, data 
will be reviewed for consistency. Missing data values will not be imputed and all non-
missing values will be used. To determine patients who had been re-enrolled in the study, 
there will be a question on the eCRF indicating whether the patient has been enrolled in 
the trial previously and the number the patient was previously enrolled under. The details 
on how data from these patients will be analyzed will be described in the SAP.
10.2 Determination of Sample Size
A formal sample size calculation was not performed. Up to 50 patients will be enrolled 
such that a total target of 30 evaluable patients complete the 12-week Study Treatment 
Period and the Follow-up Period.
10.3 Analysis Populations 
The Safety Set is based on the intent-to-treat principle and will include all patients who 
have received at least one treatment with the AMIA APD Solution Generation System 
and who have at least one measurement for the primary endpoint (either primary efficacy 
or primary safety).
10.4 Demographics and Baseline Characteristics
Demographic data include age, gender, race, height, weight, body mass index calculated 
as weight (kg)/height2 (m), and ethnicity.
Other baseline/ demographic data will include total Kt/Vurea which will be summarized by 
sample size, mean, standard deviation, median, minimum and maximum.
Demographic and baseline characteristics will be summarized on the Safety Set.

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10.5 Primary Analysis
Primary Efficacy:
AMIA APD Generated Solution specifications will be collected from the dialysis solution 
generated by the patient using the AMIA APD Solution Generation System, during 
simulated treatments. The chemical composition measurements taken from the dialysis 
solution will be summarized by count and percentage for those that meet specification vs 
those that do not. There will be three summaries of these data based on initial test values, 
based on retest values, and based on the most recent test values. Summary statistics 
including sample size, mean, standard deviation, median, minimum and maximum will 
also be presented for the chemical composition measures of the solution. These 
summaries will be provided on the Safety Set.
Primary Safety:
Product water from the WD (pre-sterilizing filters) and water in the holding bag (post-
sterilizing filters), generated during simulated treatments will be sampled. The 
measurements of product water will be summarized by count and percentage for those 
that meet ISO Standard 139591 for microbiological (including endotoxin) and chemical 
contamination vs those that do not, and the measurements from the holding bag will be 
summarized by count and percentage for those that achieve 0 CFU/mL (no growth) and 
<0.03 EU/mL vs those that do not. There will be three summaries of these data: based on
initial test values, based on retest values, and based on the most recent test values. All 
measures will also be summarized by sample size, mean, standard deviation, median, 
minimum and maximum. These summaries will be provided on the Safety Set.
10.6 Secondary Analysis
Adverse events will be mapped to a Primary System Organ Class and Preferred Terms 
according to MedDRA Version 21.0 or higher and summarized using frequencies and 
percentages. In addition, AEs will be summarized by seriousness, severity, and 
relationship to study product or typical PD therapy. Device alarms and their relation to 
AEs or SAEs will be summarized using frequency counts and percentages. Vital Signs 
(BP, pulse, temperature) will be summarized by mean, standard deviation, median, 
minimum and maximum for all recorded timepoints and also for change from pre-to post 
treatment for all post Baseline timepoints. These summaries will be conducted on the 
Safety Set.

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Total Kt/Vurea will be summarized using descriptive statistics at all collection timepoints 
and change from Baseline will also be summarized. This summary will be performed on 
the Safety Set.
10.7 Sensitivity Analysis
A sensitivity analysis of the primary safety endpoint of product water from the water 
device may be performed using the results of the home installation test in lieu of missing 
Simulated Treatment Visit 1 data.
10.8 Interim Analysis
An interim analysis is not planned for this study.
11. ADMINISTRATIVE CONSIDERATIONS
11.1 Investigators and Study Administrative Structure
The investigator will comply with the protocol (which has been approved/given favorable 
opinion by the IRB/EC/NCA), ICH GCP, the ethical principles of the Declaration of 
Helsinki, and applicable regulatory requirements as described in the Clinical Study 
Agreement. The investigator is ultimately responsible for the conduct of all aspects of the 
study at the study site and verifies by signature the integrity of all data transmitted to the 
sponsor. Whenever the term ‘investigator’ is noted in the protocol text, it may refer to 
either the PI at the site, or an appropriately qualified, trained and delegated individual of 
the investigational site. Sub-investigators or other authorized study personnel are eligible 
to sign for the investigator, except where the investigator’s signature is specifically 
required.
11.2 Institutional Review Board Approval
The responsible IRB must be constituted according to the applicable local and national 
requirements of each participating location. The Sponsor or its designee will require 
documentation noting all names and titles of members who compose the respective IRB. 
If any member of the IRB has direct participation in this study, written notification 
regarding his or her abstinence from voting must also be obtained.
The Sponsor or its designee will supply relevant documents for PIs to submit to their 
respective IRB for review and approval of the protocol. The Investigator will not enroll 
patients into the study until the Investigator has received written approval for, or written 
favorable opinion on, the protocol, the informed consent document(s), and any patient-
facing materials from their IRB. The IRB approval must refer to the study by exact 
protocol title, number, and version date; identify version of other documents (e.g., patient

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or care partner ICFs) reviewed; and state the approval date. The Investigator will make 
all required progress reports to their IRB in writing in a timely manner and will obtain all 
required approvals in writing (at least annually in all cases) to continue to participate in 
the study.
The Investigator will promptly report to their IRB any unanticipated problems associated 
with the study product involving risks to patients or others, whether encountered at their 
site or provided as a safety report by Baxter.
The Investigator will promptly notify their IRB of any planned protocol amendment and 
will not implement any protocol amendment until the IRB has provided written approval 
of, or written favorable opinion on, the amendment.
11.3 Food and Drug Administration
The Sponsor is responsible for submissions to the FDA.
Food and Drug Administration will notify the Sponsor in writing of the date it receives 
the IND.
The Baxter Project Manager may send investigational products to study sites and/or 
include patients in the study:
•
30 days after FDA receives the IND, unless FDA notifies the Sponsor that the 
investigations described in the IND are subject to a clinical hold; or
•
On notification by FDA that the clinical investigations in the IND may begin.
11.4 Ethical Conduct of the Study
This study will be conducted in accordance with the ethical principles that have their 
origin in the Declaration of Helsinki, the ethical and quality standards of GCP (ICH E6) 
and all applicable regulatory requirements and laws.
The PI will provide all necessary information on the protocol and the study product to all 
physicians, nurses, and other personnel who participate in this study under the PI’s 
supervision and will discuss this material with them as needed, to ensure that they are 
fully informed regarding the conduct of the study and the potential effects of the study 
product.

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11.5 Patient Information and Consent
The Investigator will not enroll patients into the study until the Investigator has received 
written approval for, or written favorable opinion on, the protocol and the informed 
consent documents(s), from their IRB. Prior to obtaining patient consent, the PI or 
designee will explain to the patient the nature and purpose of the study and the data to be 
provided to Baxter. The applicable ICF or authorization will be obtained from the patient 
before any study data is collected. After the ICF is signed, it will be placed in the 
patient’s medical record and a signed copy will be given to the patient. The time and date 
of informed consent should be documented in the patient’s medical records.
11.6 Patient Confidentiality
The Investigator must ensure that the patient’s confidentiality is maintained. Patient 
medical information obtained for the purposes of this study is confidential and disclosure 
to third parties, other than Health Authority representatives, Baxter representatives, or the 
site’s IRB, is prohibited. Patients should not be identified by name or medical record 
number on any documents or materials (samples, slides) sent to Baxter or its 
representatives or during verbal communications. Patients should be identified only by 
the protocol-assigned unique patient identification number.
To help maintain patient confidentiality, each patient will be assigned a unique patient
identification number. The site Investigator, designated site staff, and a limited number of 
Baxter personnel or designees will have access to patient identifying information. (Please 
refer to Section 5.11 for a full list of people with access to patient identifying 
information). All data will be compiled to construct a dataset comprising unique patient
identification numbers in lieu of specific patient identifying data; all study datasets will 
be password-protected. While there is always a risk of loss of privacy when participating 
in a research program, reasonable efforts will be made to ensure the confidentiality of 
patient data. Under no circumstances shall any patient identifying information be shared 
with or disclosed to a third party for promotional uses. As stated above, the patient must 
be informed that his/ her personal study-related data will be used by Baxter and its 
representatives in accordance with country law or local IRB data protection directives.
11.6.1 Health Insurance Portability and Accountability Act Authorization 
Procedures
Preparation of the Health Insurance Portability and Accountability Act (HIPAA) 
authorization form is the responsibility of the PI and must include all elements required 
by the Department of Health and Human Service’s Privacy Rule. Prior to the beginning 
of the study, the PI must have the IRB or the appropriate institution privacy board’s 

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written approval/favorable opinion of the HIPAA authorization form. The PI must 
provide the patient or legally-authorized representative with a copy of the HIPAA 
authorization form in the language in which the patient is most proficient. The language 
must be nontechnical and easily understood. The PI should allow the time necessary for 
the patient or the patient’s legally-authorized representative to inquire about the details of 
the authorization. The HIPAA authorization must be signed and personally dated by the 
patient or by the patient’s legally-authorized representative and by the person who 
obtained the authorization. The patient or legally-authorized representative should receive 
a copy of the HIPAA authorization form prior to the patient’s participation in the study.
11.7 Study Monitoring
The Sponsor team or designee will monitor the study data on site and remotely as part of 
safety management and clinical monitoring. Monitoring will occur at regularly scheduled 
intervals at the study site to allow for verification by sampling of source documents and 
comparing these with information recorded on the eCRFs. In addition, eCRFs may also 
be monitored remotely during the course of study participation. Full details on eCRF 
monitoring will be specified in the Clinical Operations/ Monitoring Plan.
The PI or a designated member of the PI’s staff must be available during monitoring 
visits to review data and resolve any queries and to allow direct access to the patient’s 
records (e.g., medical records, office charts, hospital charts and study-related charts) for 
source data verification. The eCRFs must be completed prior to each visit and be made 
available to the monitor so that their accuracy and completeness may be checked.
11.8 Case Report Forms and Study Records
All clinical data associated with this study will be collected and reported electronically 
via a web address and secure password. The database will be housed on a physically and 
logically secure computer server maintained in accordance with written security policies. 
The electronic data capture (EDC) system meets approved established standards for the 
security of health information and is validated per 21 CFR Part 11. The system also meets 
the ICH guideline E6R1 regarding electronic study data handling and is available for 
audit upon request. Patient confidentiality will be strictly maintained. Patient identifying 
information will not be included in the database, but must be maintained in a secure 
fashion at the Investigator site.
11.9 Access to Source Documentation
Representatives of the Sponsor, or its designee, must be allowed to visit the study site 
regularly to assess the data quality and the integrity of the study. These representatives 

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will review study records on site and directly compare these with the source documents, 
discuss the conduct of the study with the PI and verify that the facilities remain 
acceptable. In addition, the study may be evaluated by the Sponsor’s internal auditors or a 
designee and/or by government inspectors, who must be allowed access to eCRFs, source 
documents and other study files.
11.10 Data Generation and Analysis
Web-based electronic data entry must be completed for all patients enrolled in the study. 
The electronic data entry will be the responsibility of the Investigator. The database will 
be maintained by Baxter or designee.
Electronic Investigator signatures will be used to attest to the accuracy of data entered 
into the EDC system. The Study Monitor, in collaboration with the Investigators, must 
ensure that data entered into the EDC system are correct. Computerized data checks will 
be used to supplement manual review to check for data omissions, inconsistencies and 
out of range values. An electronic audit trail system will be used to track all changes in 
the database. Data editing for correction or clarification purposes must be done before the 
eCRFs have been transmitted for data processing and analysis.
Data management will be carried out by Baxter Global Clinical Development, Data 
Sciences and Reporting department or assigned designee.
Baxter or their assigned designee is responsible for the creation of the study eCRF and 
the associated electronic study database.
11.11 Retention of Data
The Institution/PI will retain all study records in compliance with applicable regulatory 
requirements and in any event a minimum of fifteen (15) years following the termination 
or completion of the study, whichever is later or as outlined in your clinical study 
agreement. The Institution/PI must contact the Sponsor before destroying any records 
associated with the study. The Sponsor or its designee will notify the Institution/PI in 
writing when the study records can be destroyed. If the PI withdrawals from the study 
(e.g., relocation, retirement), the study records shall be transferred to a mutually agreed 
upon designee (e.g., another PI), Baxter will be notified in writing of any such transfer. 
When required, Institution/PI shall make the Study records available for inspection by 
Sponsor and/or regulatory authority.

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11.12 Financial Disclosure
The financial aspects of the study will be documented in an agreement between the 
Sponsor and the Investigator.
11.13 Publication and Disclosure Policy
Any information shared by the Sponsor regarding this study, including this protocol, is 
considered proprietary information and should be kept confidential.
The data generated by this clinical study are the property of the Sponsor. This data may 
be used by the Sponsor, now and in the future, for presentation or publication at the 
Sponsor’s discretion or for submission to regulatory agencies. In addition, the Sponsor
reserves the right of prior review and approval of data from this study relative to the 
potential release of proprietary information to any publication or for any presentation.

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12. REFERENCE LIST
1.
International Organization for Standardization. 13959:2014. Water for 
haemodialysis and related therapies. Geneva, Switzerland: International Organization for
Standardization.; 2014.
2.
National Kidney Foundation. K/DOQI clinical practice guidelines for chronic 
kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002;39(2 
Suppl 1):S1-266.
3.
National guideline for the management of the viral hepatitides A, B, and C. 
Clinical Effectiveness Group (Association of Genitourinary Medicine and the Medical 
Society for the Study of Venereal Diseases). Sex Transm Infect. 1999;75 Suppl 1:S57-64.
4.
SAS Institute Inc. SAS OnlineDoc Version 9.2 - Product Documentation. Vol. 
2012. Cary, NC USA; 2008.
5.
Popovich R, Moncrief J, Decherd J, Bomar J, Pyle W. The definition of a novel 
portable/wearable equilibrium dialysis technique. Vol. 5: Trans Am Soc Artif Intern 
Organs; 1976:64.
6.
Fresenius Medical Care. Fresenius Medical Care 2015 Annual Report: ESRD 
patients in 2015: A global perspective; FMC 2015.
7.
Wang AY, Brimble KS, Brunier G, et al. ISPD Cardiovascular and Metabolic 
Guidelines in Adult Peritoneal Dialysis Patients Part I - Assessment and Management of 
Various Cardiovascular Risk Factors. Perit Dial Int. 2015;35(4):379-387.
8.
Baxter Healthcare Corporation. Amia APD Solution Generation System Patient 
Guide. Document #BXU522141. Effective Date 15 March 2018.
9.
Baxter Healthcare Corporation. Point of Care APD Clinic and Home Assessment 
Guide. Document #BXU517247. Current Issue.
10.
Baxter Healthcare Corporation. PoC APD Feed Water Specification. Document 
#BXU009418. Current Issue.
11.
Baxter Healthcare Corporation. Feed Water Sampling at Installation for Point of 
Care (PoC) Automated Peritoneal Dialysis. Document #BXU526052. Current Issue.
12.
Baxter Healthcare Corporation. BXU011787 Amia APD SGS Feed Water Sample 
Testing Results Decision Tree, Document No BXU011787-SSP-CO-019, Current Issue.
13.
Baxter Healthcare Corporation. BXU011787 Amia APD SGS Water Device 
Product Water Sample Results Decision Tree, Document No BXU011787-SSP-CO-020, 
Current Issue.
14.
Baxter Healthcare Corporation. BXU011787 Amia APD SGS Water Device 
Holding Bag Water Sample Results Decision Tree, Document No BXU011787-SSP-CO-
021, Current Issue.
15.
Baxter Healthcare Corporation. BXU011787 Amia APD SGS Sample Results 
Dialysis Solution Decision Tree, Document No BXU011787-SSP-CO-022, Current Issue.
16.
Baxter Healthcare Corporation. Amia APD Solution Generation System Patient 
Guide. Document #BXU522141. Current Issue.
17.
The Criteria Committee of the New York Heart Association. Nomenclature and 
Criteria for Diagnosis of Diseases of the Heart and Great Vessels. Boston: Mass: Little, 
Brown & Co; 1994:253-256.

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Appendix 1 Schedule of Events
Observation
Screening
(approx. 3 
weeks) 
Baseline Period 
(In-center 
Training,
approx. 2 
weeks)a
Simulated 
Treatment 
Visit 1b
Each Treatment 
Dayc
Treatment Visits 
2, 3 and 4 
(Treatment weeks 4, 
8 and 12, 
respectively)d
Total 
Kt/Vurea
Visite
Follow-up 
Period 
(5-10 days)
End of 
Study/ Early 
Termination 
Visitf
Informed Consent 
of patient and 
care partner (if 
participating)g
X
Demographicsh
X
Medication 
histories (within 
30 days of 
Screening)i
X
Physical 
examination 
including weight 
and height 
X
X
Daily weight 
(pre- and post-
dialysis)
X
X
Vital signsj
X
X
X
Home suitability 
assessmentk
X
Feed water 
analysis for the 
home
X
Xaa

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Observation
Screening
(approx. 3 
weeks) 
Baseline Period 
(In-center 
Training,
approx. 2 
weeks)a
Simulated 
Treatment 
Visit 1b
Each Treatment 
Dayc
Treatment Visits 
2, 3 and 4 
(Treatment weeks 4, 
8 and 12, 
respectively)d
Total 
Kt/Vurea
Visite
Follow-up 
Period 
(5-10 days)
End of 
Study/ Early 
Termination 
Visitf
Assessment by an 
Investigator or a 
designeel
X
X
X
X
X
X
Adverse Event 
assessmentsm
X
X
X
X
X
X
X
Concomitant 
medicationsn
X
X
X
Clinical 
laboratory 
evaluations
X
X
AMIA APD 
System specific 
trainingo
X
Comprehension 
and retention 
assessmentp
X
Investigator 
confirmation of 
prescription 
stabilityq
X
X
Written 
confirmation for 
independent carer
X
Machine 
informations
X
X

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Observation
Screening
(approx. 3 
weeks) 
Baseline Period 
(In-center 
Training,
approx. 2 
weeks)a
Simulated 
Treatment 
Visit 1b
Each Treatment 
Dayc
Treatment Visits 
2, 3 and 4 
(Treatment weeks 4, 
8 and 12, 
respectively)d
Total 
Kt/Vurea
Visite
Follow-up 
Period 
(5-10 days)
End of 
Study/ Early 
Termination 
Visitf
Machine 
observationst
X
Product Water 
Microbiological 
Test sampling 
(Simulation)u
Xv
X
X
Product Water 
Chemical
Contamination
Test sampling 
(Simulation)u
Xv
X
X
Microbiological 
testing of water 
from holding bagu
X
X
Testing of 
chemical 
composition of 
the final dialysis 
solutionu
X
X
AMIA APD 
Solution 
Generation 
System-related 
Product 
Complaints and 
Device 
Deficienciesw
X
X

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Observation
Screening
(approx. 3 
weeks) 
Baseline Period 
(In-center 
Training,
approx. 2 
weeks)a
Simulated 
Treatment 
Visit 1b
Each Treatment 
Dayc
Treatment Visits 
2, 3 and 4 
(Treatment weeks 4, 
8 and 12, 
respectively)d
Total 
Kt/Vurea
Visite
Follow-up 
Period 
(5-10 days)
End of 
Study/ Early 
Termination 
Visitf
Chlorine Testingx
X
X
Home 
installationy
X
X
Collection of 
diary source data 
(eDiary)z
X
Transition to 
conventional PD 
therapy
Xbb
a Baseline measurements will be taken during the Baseline Period (In-Center Training Period) before the patient starts treatment with AMIA APD 
Solution Generation System.
b The Simulated Treatment Visit 1 assessments will occur before the first treatment with AMIA APD Solution Generation System in the patient’s home. 
The Simulated Treatment Visit 1 can be conducted -7 days from first actual treatment.
c Assessments under Each Treatment Day column will occur every day from the first actual treatment with the AMIA APD Solution Generation System in 
the patient’s home until the last day of the 12 week Study Treatment Period
d After patients have completed the Kt/Vurea assessment required during Week 5, 6, 7 or 8 of the Study Treatment Period, in order to accommodate 
potential vacation/travel, they may voluntarily interrupt investigational AMIA APD Solution Generation System treatment and perform standard of care 
PD therapy using the marketed AMIA or HomeChoice APD Cycler with currently available PD solution (e.g. Dianeal) up to 2 separate times with prior 
approval from the Investigator for up to 14 days in total; however, patients must complete a total of 12 weeks of cumulative therapy using the AMIA 
APD Solution Generation System.
e A visit to assess Total Kt/Vurea will occur after the patient has been dialyzing with the AMIA APD Solution Generation System for at least 4 weeks 
(assessment done one time during weeks 5, 6, 7 or 8 of the Study Treatment Period). Patients who have missed 4 consecutive days of prescribed therapy 
with AMIA APD Solution Generation System should defer their Kt/Vurea assessment by 1 week to allow a full week of prescribed treatment using the 
AMIA APD Solution Generation System.
f The End of Study assessments will be performed 5-10 days after the last treatment with AMIA APD Solution Generation System, i.e., at Week 13 for 
patients who completed the 12 weeks of treatment.
g Patient may have a care partner to assist with performing study procedures. Refer to Section 5.4.1 for details of care partner’s responsibilities.

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Observation
Screening
(approx. 3 
weeks) 
Baseline Period 
(In-center 
Training,
approx. 2 
weeks)a
Simulated 
Treatment 
Visit 1b
Each Treatment 
Dayc
Treatment Visits 
2, 3 and 4 
(Treatment weeks 4, 
8 and 12, 
respectively)d
Total 
Kt/Vurea
Visite
Follow-up 
Period 
(5-10 days)
End of 
Study/ Early 
Termination 
Visitf
h Demographic data include age, gender, race, ethnicity, height, weight, body mass index = kg/m2, where kg is a person's weight in kilograms and m2 is 
their height in meters squared.
i Medication history will include all medications that are still active, taken within the 30 days prior to Screening, with each medication having a 
corresponding indication recorded in the Medication and Medical History eCRFs.
j Vital signs (BP and pulse rate) will be recorded on the eCRF at Screening, Study Visit 2, Study Visit 3, Study Visit 4, and at the End-of-Study Visit. 
Weight will be recorded at Screening and at the End-of-Study Visit. Blood pressure will be measured with an appropriate cuff size after the patient has 
been sitting for at least 5 minutes.
k Please refer to the Point of Care APD Clinic and Home Assessment Guide for the procedures involved in the home suitability assessment.9
l The Principal Investigator or a designee (e.g., sub-investigator) will assess each patient at the Screening Visit and on a weekly basis. At a minimum, this 
assessment will include evaluation of BP, pulse rate, weight, fluid status and dialysis prescription.
mAEs and SAEs will be collected after the informed consent is signed and will continue to be collected throughout the Study Treatment Period and during 
the follow-up period of 5-10 days after the last study treatment. Adverse device events and SADEs will be collected from the time of signing informed 
consent.
n Medications taken during the study will be documented throughout the study and will include a review of all major body systems and renal history 
(primary etiology of renal disease and current PD prescription).
o Patients will receive device-specific training which will last up to 2 weeks.
p Comprehension and retention testing will occur at the end of the Baseline Period (In-center Training Period) for patients and care partners (if 
participating). If the patient does not read and understand English, the care partner will assist the patient with comprehension and retention testing.
q The Investigator must reassess the stability of the patient during the Baseline Period (In-center Training Period). Once the clinician concludes that the 
patient is clinically stable and their PD prescription is stable, then the patient can begin treatment in the home.
r Written confirmation of independent care by patient and care partner (if participating).
s Machine information will include the available code number(s) and a lot/serial number(s) at initial installation and if the device or any of the disposables 
are changed.
t Machine observations with each treatment will include the following: duration of PD treatments, start and stop times, total UF volume programmed and 
removed as obtained from machine log, and technical treatment interruptions – machine alarms.

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Observation
Screening
(approx. 3 
weeks) 
Baseline Period 
(In-center 
Training,
approx. 2 
weeks)a
Simulated 
Treatment 
Visit 1b
Each Treatment 
Dayc
Treatment Visits 
2, 3 and 4 
(Treatment weeks 4, 
8 and 12, 
respectively)d
Total 
Kt/Vurea
Visite
Follow-up 
Period 
(5-10 days)
End of 
Study/ Early 
Termination 
Visitf
u Microbiological (including endotoxin) and chemical testing of product water produced in the home will occur after the installation of the AMIA APD 
Solution Generation System. Simulated treatments will occur during week 1, before the first treatment in the home with the AMIA APD Solution 
Generation System, and during Study Treatment Weeks 4, 8 and 12. The dialysis solution generated by the simulated treatment will be collected from 
the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution. Product water from the WD (pre-sterilizing 
filters) will be collected and tested to confirm that it conforms to ISO standard 13959 for microbiological (including endotoxin) and chemical 
contamination, and water from the holding bag (post-sterilizing filters), generated during a simulated treatment, will be collected and tested to confirm it 
does not exceed 0 CFU/mL for bacteria (no growth) and is < 0.03 EU/mL for endotoxins, consistent with Dianeal specifications for sterility. The 
simulated treatment will occur in addition to the patient’s normal therapy regimen (except at the last Simulated Treatment Visit, which is conducted after 
the last treatment). Patients will be required to use new AMIA APD Concentrates and disposable sets for their PD treatment. The chemical collection 
test sampling may occur on a different day than the product water microbiological test sampling.
v Tests carried out during Screening are for safety checks prior to therapy and will not be used in the analysis.
wCollection of AMIA APD Solution Generation System-related product complaints and device deficiencies, which would include functional 
characteristics (e.g., particulate matter, PD fluid discoloration, leaks, tubing separations), will begin from the time of signing informed consent and will 
continue throughout the entire Study Period.
x Chlorine testing will occur prior to every treatment on the AMIA APD Solution Generation System.
y To provide schedule flexibility for the consented patient, Baxter Service or its designee may begin the home installation process during the Screening
Period. System installation and product water from the WD (pre-sterilizing filters) testing are expected to take approximately two weeks. This will 
ensure the system is ready for activation after the patient completes their required training on the AMIA APD Solution Generation System.
z eDiary source data will include data not limited to treatment activities listed in section 5.9 of the protocol. If the patient does not speak English, the care 
partner will assist the patient with completion of the eDiary.
aa Feed water analysis for the home may take place at de-commissioning.
bb After the final Study Treatment Visit, patients are to transition back to treatments with AMIA or HomeChoice with Baxter’s approved Dianeal Low 
Calcium (2.5 mEq/L) PD Solution in their home environment and enter a 5-10 day Follow-up Period. Return of all investigational products and study 
related supplies will be scheduled during this time.

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Appendix 2 Schedule of Clinical Laboratory Evaluations
Observation
Screening
Total Kt/Vurea Visit 
Blood Draw:
Serum β-hCGa
X
Hepatitis Bb
X
Hepatitis Cb
X
CBC with differential
X
Chemistry Profilec
X
Creatinined
X
Urea Nitrogend
X
PD Effluent:
White Cell Count with differential
X
Cell Culture
X
Total Kt/Vuread
X
X
24-hour PD Effluent Collection:
Total Volume
X
X
Creatinine
X
X
Urea Nitrogen
X
X
24-hour Urine Collection:
Total Volume
X
X
Creatinine
X
X

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Observation
Screening
Total Kt/Vurea Visit 
Urea Nitrogen
X
X
a Women of childbearing potential (not menopausal or surgically sterile) must have a negative serum 
pregnancy test result within 14 days prior to initiation of study product.
-If qualitative serum β-hCG results are positive, repeat quantitative serum pregnancy test within 48 
hours.
-If quantitative serum β-hCG levels show clinically significant rise, within 48 hours, serum 
progesterone level should be taken. Serum progesterone > 5 ng/mL will exclude a patient from the 
study.
b Patients will be screened (those without a history of positive Hepatitis B or Hepatitis C serology) for 
both infections at the Screening Visit. 
-Hepatitis B: Hepatitis B surface antigen (HBsAg) in acute and chronic infection; 
-Hepatitis C: Screening assay (EIA or CIA) for anti-Hepatitis C virus (HCV). Automatic verification of 
positive Screening results by an additional, more specific assay (e.g., nucleic acid testing [NAT] for 
HCV RNA).
c The chemistry profile includes glucose, calcium, albumin, total protein, sodium, potassium, 
bicarbonate, chloride, creatinine, blood urea nitrogen, alkaline phosphatase, alanine aminotransferase, 
aspartate amino transferase, bilirubin, and phosphorous.
d To assess total Kt/Vurea, 24-hour urine (if not anuric), 24-hour PD effluent, and serum will be collected 
at Screening. However, if a total Kt/Vurea is available from within 45 days of Screening, then it will be 
used as the Screening/Baseline value (i.e., no urine and peritoneal effluent samples will be collected to 
calculate Kt/Vurea). Total Kt/Vurea assessment will also occur after the patient has been dialyzing for at 
least 4 weeks with the AMIA APD Solution Generation System, (assessment done one time during 
Week 5, 6, 7 or 8 of the Study Treatment Period.)

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Appendix 3 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 
Formulations
Component
Dianeal Low Calcium (2.5 mEq/L) PD Solution Formulation (g/L)
1.5% Dextrose
2.5% Dextrose
4.25% Dextrose
Dextrose, hydrous
15.0
25.0
42.5
Sodium chloride
5.38
5.38
5.38
Magnesium chloride
hexahydrate
0.051
0.051
0.051
Calcium chloride dihydrate
0.183
0.183
0.183
Sodium lactate
4.48
4.48
4.48
Water for injection
qs to 1000 mL
qs to 1000 mL
qs to 1000 mL
Component
Dianeal Low Calcium (2.5 mEq/L) Ionic Composition (mmol/L)
Sodium
132
Calcium
1.25
Magnesium
0.25
Chloride
95
Lactate
40
pH at 25°C
4.0 - 6.5

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Appendix 4 Formulas
The following equations d e f will be used to calculate total Kt/Vurea:
Total Kt/Vurea= Peritoneal Kt/Vurea + Renal Kt/Vurea
                                                
d Szeto C., Wong T., Leung C., et al. Importance of dialysis adequacy in mortality and morbidity of 
Chinese CAPD patients, 2000. Kidney International. 2000; 58: 400-407
e Nolph K.D., Moore H.L., Twardowski Z.J., et al. Cross-sectional Assessment of Weekly Urea and 
Creatinine Clearances in Patients on Continuous Ambulatory Peritoneal Dialysis, 1992. Asaio Journal. 
1992.
f Keshaviah P.R., Nolph K.D., Prowant B. et al. Defining Adequacy of CAPD with Urea Kinetics. Baxter 
Health Corp., University of Missouri, Columbia, and Dialysis Clinic, Inc, Columbia.

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Appendix 5 Definitions of Adverse Events of Special Interest Terms
Aseptic Peritonitis
Inflammation of the peritoneum lining the abdominal cavity as the result of 
infectious, autoimmune, or chemical processes.
Encapsulating 
Peritoneal Sclerosis
A devastating but rare complication of long-term PD. The disease is associated 
with extensive thickening and fibrosis of the peritoneum resulting in the 
formation of a fibrous cocoon encapsulating the bowel leading to intestinal 
obstruction.
Hypovolemia
An abnormal decrease in fluid volume or rapid shift from one compartment of 
body fluid to another.
Hyperglycemia
An abnormally high level of glucose in the blood.
Hypocalcemia
A low blood calcium level, occurs when the concentration of free calcium ions 
in the blood falls below 2.1 mmol/L.
Hypokalemia
A low blood potassium level, occurs when the concentration of potassium in the 
blood falls below 3.5 mmol/L.
Hyponatremia
A low blood sodium level, occurs when the concentration of sodium in the 
blood falls below 135 mmol/L.
Lactic Acidosis
Acidosis due to the buildup of lactic acid in the body.
Medication Error
Errors in prescribing, dispensing, or administering medication with the result 
that the patient fails to receive the correct drug or the indicated proper drug 
dosage.

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Appendix 6 Medical Events Commonly Associated with Peritoneal Dialysis
The following are medical events that have been commonly reported as possibly related 
to PD therapy in general: 
Abdominal pain:
A generic term for focal or general discomfort localized to the abdominal 
region.
Back pain:
Pain felt in or along the spine or musculature of the posterior thorax.
Bleeding:
The escape of blood from an injured vessel.
Chest pain:
A general term for any dull, aching pain in the thorax, usually referring to 
that of acute onset, which is often regarded as being myocardial in origin 
unless proven otherwise.
Drain pain (outflow pain):
A sense of abdominal discomfort; pain or crampy discomfort arising during 
the drain phase of a peritoneal dialysis exchange that may occur during a 
manual or automated peritoneal dialysis exchanges.
Edema (Peripheral and/or 
facial; Scrotal):
An abnormal accumulation of fluid in intercellular spaces of the body.
Fever:
A fever is any body temperature elevation over 100 °F (37.8 °C).
Headache:
Pain in the head which can arise from many disorders or may be a disorder 
in and of itself.
Hematuria:
Presence of blood or red blood cells in the urine.
Hernia:
Protrusion of a part or structure through the tissues normally containing it.
Hydrothorax:
Accumulation of serous fluid in one or both pleural cavities.
Hypertension:
Persistently high arterial blood pressure.
Hypoglycemia:
An abnormally low level of glucose in the blood.
Hypotension:
Persistently low arterial blood pressure.
Itching:
An uncomfortable sensation of irritation of the skin or mucous membranes 
that causes scratching or rubbing of the affected parts.
Chills:
A sensation of cold, with convulsive shaking of the body.
Muscle cramps:
A sudden and involuntary contraction of one or more muscles
Nausea:
An unpleasant sensation vaguely referred to the epigastrium and abdomen, 
with a tendency to vomit.
PD catheter leak:
An appearance of any moisture around the PD catheter identified as 
dialysate.
Vomiting:
The ejection of matter from the stomach in retrograde fashion through the 
esophagus and mouth.
This list does not include medical events that are part of the exclusion criteria and/or should always be 
considered an AE regardless of medical history, severity or frequency.

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Appendix 7 New York Heart Association Functional Classification
NYHA Functional Classification17
NYHA Class
Patients with Cardiac Disease (Description of HF Related Symptoms)
Class I (Mild)
Patients with cardiac disease but without resulting in limitation of physical activity. 
Ordinary physical activity does not cause undue fatigue, palpitation (rapid or 
pounding heart beat), dyspnea (shortness of breath), or anginal pain (chest pain).
Class II (Mild)
Patients with cardiac disease resulting in slight limitation of physical activity. They are 
comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, 
or anginal pain
Class III 
(Moderate)
Patients with cardiac disease resulting in marked limitation of physical activity. They 
are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, 
or anginal pain.
Class IV 
(Severe)
Patients with cardiac disease resulting in the inability to carry on any physical activity 
without discomfort. Symptoms of heart failure or the anginal syndrome may be 
present even at rest. If any physical activity is undertaken, discomfort is increased.

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Appendix 9 Investigator’s Signature
Study Title:
Performance evaluation of the AMIA Automated Peritoneal Dialysis (APD) 
Solution Generation System in patients using the AMIA APD Cycler.
Study Number:
BXU011787
Original Protocol:
2018 JUN 15
Amendment 1:
2018 OCT 16
Amendment 2:
2018 DEC 13
Amendment 3:
2019 FEB 28
Amendment 4:
2019 APR 30
Amendment 5:
2019 JUL 09
Amendment 6:
2019 NOV 01
I have read the protocol described above. I agree to comply with all applicable 
regulations and to conduct the study as described in the protocol. 
Signed:
Date:
<enter name and credentials>
<enter title>
<enter affiliation>
<enter address>
<enter phone number>