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

Not Applicable

Completed

Conditions: End-Stage Renal Disease

Interventions: Device: HemoCare™ Hemodialysis System

Registration Number: NCT04087213

Lead Sponsor: Deka Research and Development

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 conventional HD, short daily HD or extended-duration HD therapy during the daytime or at night dependent on the users' lifestyle or work schedule. This multi-center, open-label, single-arm cross-over study is designed specifically to gather and evaluate safety data for the use of the HemoCare™ Hemodialysis System (including labeling and training tools) during home nocturnal (during sleeping hours based on the patient schedule) use. Nocturnal HD therapy was chosen as a treatment in this study because of the clinical and humanistic benefits associated with it. In addition, its risk profile, especially when performed in a home setting, may be greater than either existing conventional or short daily HD therapies. In this regard, establishing an acceptable safety profile for home nocturnal HD therapy should be sufficient evidence to support conventional and short daily HD home therapies with HemoCare™ Hemodialysis System.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

Inclusion Criteria

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 Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The HemoCare™ Hemodialysis System	HemoCare™ Hemodialysis System	The HemoCare™ Hemodialysis System is intended for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare™ Hemodialysis System is intended for use in chronic dialysis facilities, self-care dialysis facilities, or the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed under the supervision or assistance of a medical professional or a care partner who has been trained and deemed competent in the use of the device by the prescribing physician.

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	31 weeks	Adverse event (AE) rate per 100 HemoCare™ Hemodialysis System treatments during Assisted and Unassisted Home Evaluable Periods
Primary Performance Endpoint	31 weeks	Weekly stdKt/Urea was calculated from pre- and post-dialysis urea levels during each evaluable period. Blood samples were obtained every two weeks during each Evaluable Period. For the primary performance endpoint, 'success' is defined as a subject who has all stdKt/Vurea measures in an evaluable period greater than or equal to 2.0.

Secondary Outcome Measures

Name	Time	Method
The Number of Decreased and Increased Post-dialysis Serum Potassium During Each Evaluable Period.	31 weeks	The number of decreased serum potassium defined as at least 1 post-dialysis serum potassium level of \< 3.5 meq/L , and the number of elevated serum potassium defined as at least 1 post-dialysis serum potassium level of \> 5.9 meq/L, will each be compared between Evaluable Periods with exact McNemar's tests.
Weight Change and Fluid Removed Comparison Between Evaluable Periods	31 weeks	HemoCare Ultrafiltration Comparison by Evaluable Period was determined by the following: Discrepancy between Weight Change and Net UF removed = Weight change - Net UF Removed Weight change = Ending weight - Starting weight (measured by digital weight scale). Net Ultrafiltration Removed = total UF removed - prime \& rinseback, reported by the HemoCare system. Note: One kilogram (kg) = one liter (L) of fluid
The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)	31 weeks	Number of anticipated and unanticipated AEs and SAEs during each Evaluable Period including number of device-related AEs and SAEs.
The Number of Decreased and Increased Post-dialysis Serum Phosphorus Levels	31 weeks	The number of decreased serum phosphorus defined as at least 1 post-dialysis serum phosphorus level \< 2.2 mg/dL , the number of elevated serum phosphorous defined as a least 1 post-dialysis serum phosphorus level \> 5.5 mg/dL, will each be compared between Evaluable Periods with exact McNemar's tests.

Trial Locations

Locations (8): Dialysis Clinic Inc. - Knoxville
🇺🇸
Knoxville, Tennessee, United States
The Rogosin Institute
🇺🇸
New York, New York, United States
Dialysis Clinic, Inc - NJ
🇺🇸
North Brunswick, New Jersey, United States
Wellbound South Austin
🇺🇸
Austin, Texas, United States
Dialysis Clinic, Inc.
🇺🇸
Nashville, Tennessee, United States
Wellbound North Austin
🇺🇸
Austin, Texas, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
University of Mississippi Medical Center
🇺🇸
Jackson, Mississippi, United States