N/A
N=25
An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System
End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT04198012 ↗Enrolled (actual)
25
Serious AEs
60.0%
Results posted
Sep 2025
Primary outcome: Primary: Number of Subjects With Safety Event — 20; 20; 5; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HemoCare™ Hemodialysis System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Deka Research and Development
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Safety Event |
20; 20; 5; 6; 12; 0 | — |
Summary
This study is designed to monitor and assess the safety of continued access to the HemoCare™ Hemodialysis System used during the review of the pre-market notifications for the devices in the HemoCare™ Hemodialysis System.
Eligibility Criteria
Inclusion Criteria
- Completed DEKA Protocol DKPL 00057 001 and are qualified to enter the study based on the assessment of the Investigator.
- Are willing to comply and capable of complying with the study requirements for therapy with the HemoCare™ Hemodialysis System.
- Have a trained study care partner able to support subject for all at-home study treatments.
- Subject and care partner can read and understand English and provide written informed consent.
- Have a stable functioning vascular access as judged by the treating physician.
Exclusion Criteria
- 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.
- Have any 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.
- 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.
- Are participating or planning to participate in any other interventional studies except DKPL-00057-001.
Data sourced from ClinicalTrials.gov (NCT04198012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.