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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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.
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
Primary Safety Endpoint
Adverse event (AE) rate per 100 HemoCare™ Hemodialysis System treatments during Assisted and Unassisted Home Evaluable Periods
Time frame: 31 weeks
Primary Performance Endpoint
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.
Time frame: 31 weeks
The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)
Number of anticipated and unanticipated AEs and SAEs during each Evaluable Period including number of device-related AEs and SAEs.
Time frame: 31 weeks
The Number of Decreased and Increased Post-dialysis Serum Phosphorus Levels
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.
Time frame: 31 weeks
The Number of Decreased and Increased Post-dialysis Serum Potassium During Each Evaluable Period.
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.
Time frame: 31 weeks
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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
Weight Change and Fluid Removed Comparison Between Evaluable Periods
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
Time frame: 31 weeks