End-Stage Renal Disease (ESRD)
Clinical Evaluation of the HemoCare™ Hemodialysis System for Home Nocturnal Hemodialysis (DKPL-00057-001)
Principal Investigator and Contact Information
Open for Enrollment
Brief Summary of the Protocol
The purpose of this research study is to obtain information on the safety and effectiveness of the HemoCare™ Hemodialysis System for End-Stage Renal Disease (ESRD). The HemoCare™ Hemodialysis System is an investigational device. This means that it has not been approved for use, other than in this clinical study, by the U.S. Food and Drug Administration (FDA) for treating ESRD.
Participants and care partners will be trained to use the hemodialysis system at home. The study will last for 16-31 weeks and include the following periods: Screening, In-Facility Introduction, Transition (In-facility or home), Assisted Evaluable (In-facility or home), Transition (home), and Unassisted Evaluable (home). Additional time can be added for those that need extra training or an extended period to reach the required number of 21 study treatments in the Assisted and Unassisted periods. Study treatments will occur at least every other day during the study. At least two study visits to the site will take place, once during each Evaluable period.
Physical exams, blood tests, dialysate testing, electrocardiograms, and questionnaires will be performed at all or some study visits, and participants will be asked to complete electronic diaries for each study treatment. Participants will receive a study stipend and some reimbursement for utility usage and travel.
- Males or females, 18 years of age or older
- Have been diagnosed with ESRD
- Are willing to comply with the device training and study treatment requirements
- Have been dialyzing in a medical facility or at home for at least 3 times per week
- Able to allow home modifications needed for installation of the home hemodialysis machine
Additional eligibility criteria will be reviewed when you contact the study team.
The potential benefits of participating in the study depend on the individual participant. However, there is no guarantee that participants will receive a direct benefit from this study. The study may help others in the future by providing further understanding of the benefits of nocturnal hemodialysis and the use of this system as a potential treatment option.
DEKA Research & Development Corp
Institutional Review Board (IRB)
Protocol ID: Pro00034560
ClinicalTrials.gov Identifier: NCT04087213