Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
a study on End Stage Renal Disease Kidney Disease Dialysis
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Torrance, California and other locations
- Dates
- study startedstudy ends around
- Principal Investigator
- by Jenny Shen, MD
Description
Summary
The purpose of this study is to compare days-off (5 or 6 days a week) with daily (7 days a week) peritoneal dialysis (PD) in adults who are starting PD to treat kidney failure and make at least 16 ounces (two cups) of urine a day. Once enrolled, participants will be placed into one of two groups by chance, like flipping a coin: days-off PD or daily PD. Participants will be asked to stay on the assigned PD schedule (days-off or daily) for at least 6 months. After that, participants will continue this schedule for as long as it continues to be right for their health. Participants will be followed for as long as they remain on PD, up to 24 months. Most participants assigned to the days-off schedule will switch to daily PD at some point between 6 and 24 months because of further drop in urine output. Other than days per week, all parts of participant's PD prescription will be decided by their care team at their regular monthly PD clinic visits, just as if they were not in the study. Study visits will happen around the time of these regular clinic visits. No extra trips are required. Participants will be asked to complete surveys. Most other study data will be collected from the medical chart. No blood or biological samples will be taken for the study.
Official Title
Comparative Effectiveness of Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
Keywords
Kidney Failure, Peritoneal Dialysis, Renal Insufficiency, Daily Peritoneal Dialysis, Days-off Peritoneal Dialysis, Days-off Peritoneal Dialysis (5-6 days/week)
Eligibility
You can join if…
Open to people ages 18 years and up
- Willingness to give written informed consent prior to any study-related procedures being performed.
- End-stage kidney disease, with first maintenance dialysis (PD or HD) initiated within 120 days prior to randomization.
- Home PD initiated within 30 days prior to randomization, defined as first PD exchange performed at home following completion of PD training.
- Residual kidney function, measured on a clinically obtained 24-hour urine collection within 45 days prior to randomization, demonstrating both (a) urine volume ≥500mL/24 hours and (b) urine clearance (mean of urea and creatinine clearance) ≥6 to <12 L/min/1.73m2
- In the judgment of the treating nephrologist, expected to remain on PD for at least 6 months following randomization
- Expected to receive ongoing PD care at the study enrollment site for the duration of study follow-up.
- Willingness to accept either randomized treatment assignment, adhere to the treatment schedule, and adhere to protocol schedule of activities.
- Sufficient fluency in English or Spanish to understand study materials and complete study assessments.
You CAN'T join if...
- A laboratory-documented decline of ≥50% in residual kidney function (24-hour urine volume or mean of urea and creatinine clearance) since initiation of maintenance dialysis (HD or PD).
- Initiated maintenance dialysis due to kidney transplant failure.
- During the run-in period, requirement of either of the following for clinical purposes: (a) 7-day-per-week PD prescription or (b) a daytime dwell, if receiving automated peritoneal dialysis (APD).
- Any other condition that, in the judgment of the investigator, would make the participant unsuitable for days-off PD for at least 6 months following randomization.
- Concurrent participation in another interventional clinical trial.
- Known pregnancy or nursing at the time of screening, or of child-bearing potential and planning for possible pregnancy during the study period.
- Any condition that, in the judgment of the investigator, would make the participant unsuitable for the study or preclude participation for at least 6 months following randomization (e.g., anticipated kidney transplantation, anticipated transfer of dialysis care outside a participating study site, life expectancy <6 months, or other significant medical, psychiatric, or social circumstances).
Locations
- Lundquist Institute at Harbor-UCLA Medical Center
Torrance California 90502 United States - University of Washington (UW)
Seattle Washington 98195 United States
Lead Scientist at UCLA
Details
- Status
- not yet accepting patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- University of Michigan
- ID
- NCT07922772
- Study Type
- Interventional
- Participants
- Expecting 450 study participants
- Last Updated