End Stage Renal Disease (ESRD)
An Open Label Study to Allow Patients Continuous Use of the HemoCareTM Hemodialysis System for Home
Hemodialysis Prior to Market Authorization (DKPL-00674-001)
Principal Investigator and Contact Information
Open for Enrollment by Invitation
Brief Summary of the Protocol
The purpose of this research study is to allow participants who completed the study, “Clinical Evaluation of the HemoCare™ Hemodialysis System for Home Nocturnal Hemodialysis” (DKPL-00057-001), to continue to use this System for home hemodialysis. 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.
The study will last for approximately 12 months. Study treatments will occur at least every other day during the study. Study visits will occur once a month at the study site in accordance with standard of care. 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.
- Completed the DKPL-00057-001 study and are qualified to enter the study.
- Are willing to comply and capable of complying with the study requirements for study treatment with the HemoCare™ Hemodialysis System.
- Additional eligibility criteria will be reviewed when you contact the study team.
The potential benefits for participating in the study depend on the individual participant. However, there is no guarantee that participants will receive direct benefit from this study. The study may help others in the future by providing further understanding of the benefits of nocturnal hemodialysis and use of this system as a potential treatment option.
DEKA Research & Development Corp
Institutional Review Board (IRB)
Protocol ID: Pro00040596
ClinicalTrials.gov Identifier: NCT04198012