Peritoneal Dialysis Schedules for Kidney Failure

Not yet recruiting at 9 trial locations
NC
Overseen ByNicole Cawrse, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

BR

Bruce Robinson, MD, MS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults with kidney failure who are starting peritoneal dialysis and still make at least two cups (16 ounces) of urine a day. Participants must be able to follow the assigned dialysis schedule.

Inclusion Criteria

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 give written informed consent prior to any study-related procedures being performed
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Exclusion Criteria

Known pregnancy or nursing at the time of screening, or of child-bearing potential and planning for possible pregnancy during the study period
My kidney function has dropped by at least half since starting dialysis.
Any other condition that would make the participant unsuitable for days-off PD for at least 6 months following randomization in the judgment of the investigator
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What Are the Treatments Tested in This Trial?

Trial Overview

The study compares two ways of doing peritoneal dialysis: every day (7 days a week) versus taking one or two days off each week (5-6 days). Participants are randomly assigned to either group and followed for up to 24 months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Days-off Peritoneal Dialysis (5-6 days/week)Experimental Treatment1 Intervention
Group II: Daily Peritoneal Dialysis (7 days/week)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+