An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System for Home Hemodialysis Prior to Market Authorization
Phase: NA
Conditions: End Stage Renal Disease
Sponsor: Deka Research and Development



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an overview will be provided of the total number of subjects 
having at least one: 
a. anticipated AE 
b. anticipated SAE 
c. unanticipated AE 
d. unanticipated SAE 
e. device-related AE 
f. device-related SAE (UADE) 
The proportion of subjects having at least one AE within each of 
these six AE subgroups will be summarized descriptively. 
Furthermore, the proportion of subjects having AEs within each 
of these 6 AE subgroups will be summarized by SOC, PT and 
severity (mild, moderate or severe) for the most severe rating of 
each AE per subject. And, the AE rate per 100 HemoCare™ 
Hemodialysis System treatments will be calculated. 
Descriptive summary statistics will be provided for the visit 
values and change from baseline in monthly laboratory 
assessments. Baseline observation data for all assessments are 
defined in section 11.4 and unless otherwise specified therein, 
are the last observational values brought forward from DEKA 
Protocol DKPL-00057-001. 
Study Population: 
All subjects who complete DEKA Protocol DKPL-00057-001 
and meet all of the inclusion criteria and exclusion criteria will 
be eligible to enroll into this extension study. 
Study Duration: 
Unless subject participation is discontinued prior to market 
authorization (e.g., subject withdrawal, investigator decision, 
Sponsor decision), enrolled subjects may continue treatment in 
this protocol until the HemoCare™ Hemodialysis System 
obtains market authorization. 
Study Design and 
Methodology: 
This is an open-label rollover study for subjects and care partners 
who have completed DEKA Protocol DKPL-00057-001. Enrolled 
subjects will continue to receive home hemodialysis per clinician 
prescription. Subjects will be seen in the clinic for monthly labs 
which, at a minimum, would include: hemoglobin,   BUN,  
creatinine,   electrolytes,   calcium,   and phosphorus. Water 
sampling will be done annually or as required by site policy or 
local regulations, ultrapure (water or dialysate) sampling will be 
done quarterly or as required by site policy or local regulations, 
and venous line infusion quality dialysate sampling will be done 
monthly. 

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Inclusion Criteria: 
All of the following criteria must be met for the subject to be 
eligible for participation. This study will enroll subjects who: 
1. Completed DEKA Protocol DKPL-00057-001 and are 
qualified to enter the study based on the assessment of 
the Investigator. 
2. Are willing to comply and capable of complying with the 
study requirements for therapy with the HemoCare™ 
Hemodialysis System. 
3. Have a trained study care partner able to support subject 
for all at-home study treatments. 
4. Subject and care partner can read and understand English 
and provide written informed consent. 
5. Have a stable functioning vascular access as judged by 
the treating physician. 
Exclusion Criteria: 
If any of the following criteria are met, the potential subject will 
not be considered eligible for participation. This study will 
exclude subjects who: 
1. Have a current self-reported pregnancy or are actively 
planning to become pregnant within the next 12 months, 
lactating, or not using medically acceptable means of 
contraception during the study. 
2. Have any other clinically significant medical disease or 
condition or subject responsibility that, in the 
Investigator’s opinion, may interfere with a subject’s 
(and/or care partner’s) ability to give informed consent, 
adhere to the protocol, interfere with assessment of the 
investigational 
product 
(IP), 
or 
serve 
as 
a 
contraindication to the subject’s participation in the 
study. 
3. Have a significant psychiatric disorder or mental 
disability that could interfere with the subject’s ability   to 
provide informed consent and/or comply with study 
procedures. 
4. Are participating or planning to participate in any other 
interventional studies except DKPL-00057-001. 

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The proportion of subjects having at least one AE within each of 
these six AE subgroups will be summarized descriptively. 
Furthermore, the proportion of subjects having AEs within each 
of these six AE subgroups will be summarized by SOC, PT and 
severity (mild, moderate or severe) for the most severe rating of 
each AE per subject. And, the AE rate per 100 HemoCare™ 
Hemodialysis System treatments will be calculated. 
Descriptive summary statistics will be provided for the visit 
values and change from baseline in monthly laboratory 
assessments. Baseline observation data for all assessments 
unless otherwise specified are the last observational values 
brought forward from DEKA Protocol DKPL-00057-001. 

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• HemoCare™ Bicarbonate Concentrate Set 
• HemoCare™ Water Device 
• HemoCare™ Connectivity Platform 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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6.10.3 Accessibility and Control of Study Participant Data 
In order to ship IP and service investigational devices to/at subjects’ homes, 
 
a subset of sponsor personnel and 
designees will need access to shipping addresses/contact information. A study-
specific procedure will be created and implemented by DEKA R&D 
 
to document how they will collect, control, and secure subjects’ 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 subjects will have the ability to notify study personnel of service needs to 
ensure timely installation/service of device and supply delivery. 
 
Sponsor or designees will service devices directly in subjects’ homes, collect blood 
and 
water samples, and designated couriers will deliver specified 
investigational and non-investigational product (e.g., acid concentrate and 
HemoCare™ Bicarbonate Concentrate Set) directly into subjects’ 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 subjects end their study participation and 
all investigational products are removed from the subjects’ homes 
 
 
 
7 STUDY ACTIVITIES 
7.1 Demographics and Baseline Characteristics 
Medical history and medications will be reviewed and updated as necessary. Demographics 
(age, gender, race, and ethnicity) were recorded in DEKA Protocol DKPL-00057-001. For 
this study, baseline observation data for all assessments are defined in section 11.4 and 
unless otherwise specified therein, are the last observational values brought forward from 
DEKA Protocol DKPL-00057-001.Physical Examination 
 
Physical examinations will be performed at End of Study visit. 
 
An attempt should be made to perform a final physical examination on subjects who 
discontinue from the study early, particularly if the subject is discontinuing from the study 
because of an AE.

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7.7 Clinical Observations 
Each time a subject is dialyzed with HemoCare™ Hemodialysis System, the following 
information will be obtained from HemoCare™ Connectivity Platform and Treatment 
Flowsheet: 
 
• Medications given during or immediately after treatment 
• Anticoagulation regimen  
• Treatment interventions 
• Patient weight: pre- and post-dialysis (if unable to enter post-dialysis weight in device, subject 
will note the weight on the Treatment Flowsheet) 
• Blood pressure: both pre and post-dialysis seated 
• Pulse: both pre-dialysis and post-dialysis seated 
• Body temperature: pre- and post-dialysis 
 
A study nurse or their designee will collect study data monthly (minimum) as detailed in 
the section below. The Investigator or designee will assess each subject on a weekly basis 
according to care plan (see Section 7.8). The assessment may include blood pressure, fluid 
status, and dialysis prescription.

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System shall not exceed microbial or endotoxin levels as stated in ANSI/AAMI/ISO 
23500-5:2019 standard. Based on this standard, the acceptable limit for 
microorganisms is < 0.1 CFU/mL and the acceptable limit for endotoxin is < 0.03 
EU/mL. 
 
7.9.3 Process for Responding to Out-of-Specification Results 
7.9.3.1 Decision Tree 
Clinical study decision trees for ultrapure samples have been developed and will be 
provided to study sites. These decision trees provide guidance to the clinical site 
and the DEKA R&D 
 team on appropriate actions to be taken 
in situations where OOS results are received from ultrapure 
 
 
Upon confirmation of an OOS value for either endotoxin or bacteria, the user will 
be directed to replace 
if applicable. 
 
 
 
 
 
 
Additional actions are described as follows: 
• Resample. 
• All device logs evaluated for anomalies. 
• Procedure checklists recorded during sample collection and processing 
reviewed for anomalies. 
• 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, etc. 
7.9.4 Chloramine, pH, and Conductivity Testing 
Chloramine testing of the water for dialysis will be completed according to standard-
of- care and local requirements.