Status:
COMPLETED
Study of HemoCare™ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD
Lead Sponsor:
Deka Research and Development
Collaborating Sponsors:
CVS Kidney Care LLC.
Conditions:
End-Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
The HemoCare™ Hemodialysis System has been evaluated in previous clinical trials and is designed to perform hemodialysis (HD) in a clinic setting, in a self-care setting, or in a home environment for ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04087213
Start Date
September 5 2019
End Date
January 11 2023
Last Update
August 13 2024
Active Locations (8)
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1
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39213
2
Dialysis Clinic, Inc - NJ
North Brunswick, New Jersey, United States, 08902
3
The Rogosin Institute
New York, New York, United States, 11021
4
Dialysis Clinic Inc. - Knoxville
Knoxville, Tennessee, United States, 37924