The purpose of this study is to determine non-inferiority in safety and efficacy when Quanta SC+ is used in the self-care home environment compared to a hemodialysis facility.
This clinical trial is being conducted to evaluate the Quanta SC+ hemodialysis System for home use by patients with established kidney failure. A dialysis prescription of 3 sessions per week, 4 hours per session, or facility standard will be provided during the in-clinic training period, followed by the home period with a dialysis prescription of 4 sessions per week, 3.5 hours per session.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Following the in-clinic training phase and one week transition, the intervention of self or care partner hemodialysis delivered in the home setting will occur for 8 weeks.
Capital Nephrology Medical Group
Sacramento, California, United States
Home Dialysis Therapies of San Diego / UCSD
San Diego, California, United States
Satellite WellBound
San Leandro, California, United States
Mean Standardized Weekly Kt/V (Efficacy)
The primary effectiveness endpoint was the delivery of a mean standardized weekly Kt/V of greater than or equal to 2.1 in both the clinic phase and the home phase. The weekly standard Kt/V is used to assess dialysis effectiveness by taking into account the clearance provided by individual treatments and the number of times per week the participant treated. The weekly standardized Kt/V is calculated using K (clearance of urea), T (treatment time), and V (urea distribution volume). Current practice guidelines include achieving a minimum result of 2.1 with a target of achieving 2.3, with higher values representing better outcomes. A theoretical range for the minimum and maximum standardized weekly Kt/V does not exist.
Time frame: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.
Adverse Event Rate
Adverse event rate: the number of adverse events per 100 treatments that occurred during the study, as defined by: * Serious adverse event (SAE) * Allergic reaction: type A, anaphylactoid or type B dialyzer reactions to dialyzer, blood tubing, or chemical disinfectant. * Blood loss: resulting in hemodynamic compromise that led to death, transfusion, or fluid resuscitation with greater than 1 liter of crystalloid IV fluids. * Hemolytic reaction: due to disinfectant exposure, dialysate temperature, mechanical failure, or other device related causes. * Infection: related to hemodialysis catheter, its tunnel or exit site, arteriovenous fistula (AVF), or arteriovenous graft (AVG). * Intradialytic event: a significant clinical event such as loss of consciousness, cardiac arrest, or seizure caused by device failure. * Vascular access complication * Pyrogenic reaction
Time frame: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.
Rate of Serious Adverse Events (SAEs) Per 100 Treatments.
Number of SAEs per 100 treatments occurring in the in-clinic portion of the study compared with those occurring in the home portion
Time frame: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.
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Satellite - WellBound
San Mateo, California, United States
Satellite - WellBound
Santa Rosa, California, United States
High Desert Nephrology Medical Group
Victorville, California, United States
Ocala RKCHD At Home
Ocala, Florida, United States
Southeastern Clinical Research Institute, LLC
Augusta, Georgia, United States
DaVita Home Dialysis of Indianapolis
Indianapolis, Indiana, United States
New Hyde Park Dialysis Center
New Hyde Park, New York, United States
...and 3 more locations