Study of HemoCare™ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD

Completed · Not applicable

Conditions studied: End-Stage Renal Disease

In brief

This prospective multi-center, open-label, single-arm study intends to gather and evaluate safety data for the nocturnal use of the HemoCare™ Hemodialysis System.

Key facts

Study ID

NCT04087213

Run by

Deka Research and Development

People needed

36

Starts

2019-09-05

Expected to finish

2023-01-11

Last updated by the study team

2024-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have been diagnosed with ESRD and are ≥ 18 years of age.
• Are in stable clinical condition as judged by the treating physician, and confirmed by medical history, physical exam, and laboratory testing for 30 days prior to enrollment.
• Have been receiving HD for at least 30 days prior to study enrollment, are expected to survive for at least 12 months and in the opinion of the Investigator are stable to start in the trial.
• Have been dialyzing in a supervised medical facility or at home for ≥ 3 times per week.
• Are willing to comply with the study requirements for training and therapy with HemoCare™ Hemodialysis System for the entire study treatment period.
• Understand English and can provide written informed consent (both the subject and care partner).
• Are judged by the Investigator to be suitable for Home HD (the Investigator deems that with appropriate training, the subject and/or care partner will be able to successfully cannulate and/or manage the vascular access during the Unassisted Home Evaluable Period).
• Have a stable functioning vascular access as judged by the treating physician.
• Have a weekly stdKt/Vurea ≥ 2.0, an equivalent URR ≥ 0.65, rated Kt/Vurea ≥ 1.0 on one occasion within 30 days prior to enrollment.

You may not qualify if…

• Are pre-scheduled for a living donor transplant within the next 6 months.
• Have a contraindication to heparin.
• Are currently participating in another interventional study.
• Have experienced an acute myocardial infarction with hospitalization, coronary artery bypass surgery, or acute coronary ischemia requiring angioplasty or stent insertion within 90 days of screening.
• Have ongoing NYHA Class III or IV heart failure.
• 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.
• Have ongoing sepsis or bacteremia and currently require IV antibiotics.
• Have an allergy to polysulfone dialyzer.
• Current self-reported pregnancy, actively planning to become pregnant within the next 12 months, lactating, or not using medically acceptable means of contraception during the study.
• Subject with fluid overload due to intractable ascites secondary to liver cirrhosis

Where it is running

• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Dialysis Clinic, Inc - NJ — North Brunswick, New Jersey, United States
• The Rogosin Institute — New York, New York, United States
• Dialysis Clinic Inc. - Knoxville — Knoxville, Tennessee, United States
• Dialysis Clinic, Inc. — Nashville, Tennessee, United States
• Wellbound South Austin — Austin, Texas, United States
• Wellbound North Austin — Austin, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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