Days-Off Versus Daily Initial Peritoneal Dialysis Prescription

Comparative Effectiveness of Days-Off Versus Daily Initial Peritoneal Dialysis Prescription

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Failure
• Intervention / Treatment: Procedure: Daily Peritoneal Dialysis; Procedure: Days-off Peritoneal Dialysis

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicole Cawrse, MS; Phone Number: 734-936-4888; Email: cawrse@med.umich.edu

Study Locations

• United States
  • California
    • Torrance, California, United States, 90502
      • Lundquist Institute at Harbor-UCLA Medical Center
      • Principal Investigator: Jenny Shen, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
      • Principal Investigator: Jason Cobb, MD
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwestern University
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • University of Indiana
      • Principal Investigator: Nupur Gupta, MD
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
      • Principal Investigator: Balazs Szamosfalvi, MD
  • New York
    • New York, New York, United States, 10021
      • Rogosin Institute, Inc (New York-Presbyterian Hospital/Weill Cornell Medicine)
      • Principal Investigator: Daniil Shimonov, MD
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine (MSSM)
      • Principal Investigator: Sharma Shuchita, MD
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27109
      • Wake Forest University School of Medicine (WFUSM)
      • Principal Investigator: Mariana Murea, MD
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern (UTSW)
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington (UW)
      • Principal Investigator: Rajnish Mehrotra, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Willingness to give written informed consent prior to any study-related procedures being performed.
2. End-stage kidney disease, with first maintenance dialysis (PD or HD) initiated within 120 days prior to randomization.
3. Home PD initiated within 30 days prior to randomization, defined as first PD exchange performed at home following completion of PD training.
4. 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
5. In the judgment of the treating nephrologist, expected to remain on PD for at least 6 months following randomization
6. Expected to receive ongoing PD care at the study enrollment site for the duration of study follow-up.
7. Willingness to accept either randomized treatment assignment, adhere to the treatment schedule, and adhere to protocol schedule of activities.
8. Sufficient fluency in English or Spanish to understand study materials and complete study assessments.

Exclusion Criteria:

1. 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).
2. Initiated maintenance dialysis due to kidney transplant failure.
3. 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).
4. 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.
5. Concurrent participation in another interventional clinical trial.
6. Known pregnancy or nursing at the time of screening, or of child-bearing potential and planning for possible pregnancy during the study period.
7. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Daily Peritoneal Dialysis (7 days/week); Approximately 225 participants	Procedure: Daily Peritoneal Dialysis; After a 7-15 day run-in period of daily PD, participants remain on a daily PD prescription for the duration of follow-up. Other elements of the PD prescription are at the discretion of the clinical team. Participants will be followed until death, long-term transfer to HD, kidney transplantation, recovery of kidney function such that maintenance dialysis is no longer required, participant withdrawal, or completion of 24 months of follow-up, whichever occurs first.
Experimental: Days-off Peritoneal Dialysis (5-6 days/week); Approximately 225 participants	Procedure: Days-off Peritoneal Dialysis; After a 7-15 day run-in period of daily PD, participants switch to PD prescription 5 or 6 days per week. Other elements of the PD prescription are at the discretion of the clinical team. The treatment assignment is continued for at least 6 months and then for as long as possible until clinically indicated otherwise. Many participants are expected to eventually switch to daily PD, intended as a long-term switch, to compensate for decline in residual kidney function over time. Duration of follow-up is as in the active comparator arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of composite clinical events during follow up	Each occurrence of the following during follow-up: (1) death, all cause; (2) long-term transfer to hemodialysis (HD), defined as transfer identified as long-term or identified as short-term but lasting ≥ 90 days; (3) peritoneal dialysis (PD)-related infection, defined as PD-associated peritonitis meeting International Society for Peritoneal Dialysis (ISPD) diagnostic criteria; and (4) hospitalization lasting ≥ 24 hours.	Day 1 (start of randomized treatment) through Month 24 of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized Outcomes in Nephrology - Life Participation (SONG-LP) score (Patient reported outcome)	The SONG-LP instrument is a 4-item patient-reported outcome measure developed by the SONG initiative to assess life participation, i.e. the ability to take part in meaningful activities. The four items cover leisure activities, family activities, work (including employment, housework, and study), and social activities. Participants rate how often they were able to take part in each activity over the past month on a 5-point scale from 0 ("never") to 4 ("always"). The summary score is the mean of the four item scores and ranges from 0 to 4. Higher scores indicate greater life participation (better outcome).	Months 0, 1, 3, 9, 12, 18, and 24; Key secondary outcome is Month 0 to Month 6.
Illness Intrusiveness Ratings Scale (IIRS) score (Patient reported outcome)	The IIRS is a 13-item self-report instrument. It measures how much a person's illness and its treatment interfere with 13 life domains that are important to quality of life. The domains are health, diet, work, active recreation, passive recreation, financial situation, relationship with spouse or partner, sex life, family relations, other social relations, self-expression and self-improvement, religious expression, and community and civic involvement. Each item is rated on a 7-point scale from 1 ("not very much") to 7 ("very much"). The total score is the sum of the 13 item ratings and ranges from 13 to 91. Higher scores indicate greater illness intrusiveness (worse outcome).	Months 0, 1, 3, 6, 9, 12, 18, and 24
Kidney Disease Quality of Life 36-Item Short Form Summary Score (KDQOL-36 KSS) (Patient reported outcome)	The KDQOL-36 is a 36-item, kidney disease-specific health-related quality of life instrument. Higher scores indicate better health related quality of life instrument. Items 1-12 make up the SF-12 generic core. The remaining 24 items form three kidney disease-specific subscales. Higher scores on the KDQOL-36 KSS indicate better health related quality of life.	Months 0, 3, 6, 12, and 24
Change in Kidney Disease Quality of Life 36-Item Short Form Survey (KDQOL-36) kidney disease-specific subscale scores (Patient reported outcome)	Subscales include Burden of Kidney Disease (items 13-16), Symptoms and Problems of Kidney Disease (items 17-28), and Effects of Kidney Disease on Daily Life (items 29-36). Each kidney disease-specific subscale is scored from 0 to 100 according to the RAND scoring manual. Higher scores indicate better subscale-specific quality of life.	Months 0, 3, 6, 12, and 24
Number of episodes of low small-solute clearance (weekly Kt/V [peritoneal + renal] < 1.7).	Counts, for episodes of weekly urea clearance (peritoneal + renal) normalized to total body water (Kt/V [P+R]) < 1.7.	Day 1 through Month 24 of follow-up
Number of episodes of serum potassium ≥ 6.0 mEq/L	Counts, for episodes of hyperkalemia, defined as serum potassium ≥6.0 mEq/L	Day 1 through Month 24 of follow-up
Number of episodes of serum phosphate ≥ 7.0 mg/dL	Counts, for episodes of hyperphosphatemia, defined as serum phosphate ≥7.0 mg/dL	Day 1 through Month 24 of follow-up
Number of episodes of serum CO2 ≤17 mmol/L	Counts, for episodes of serum total carbon dioxide (CO2; bicarbonate) ≤ 17 mmol/L	Day 1 through Month 24 of follow-up
Number of episodes of serum sodium < 130 mEq/L	Counts, for episodes of hyponatremia, defined as serum sodium < 130 mEq/L.	Day 1 through Month 24 of follow-up

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Bruce Robinson, MD, MS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030

Study Registration Dates

• First Submitted: November 2, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 6, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Peritoneal Dialysis
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency
• Other Study ID Numbers: HUM00302656; BPS-2025C1-44706 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified study data will be deposited in the Patient-Centered Outcomes Data Repository (PCODR) at ICPSR.

IPD Sharing Time Frame

From date of final research report submission to PCORI for at least 7 years.

IPD Sharing Access Criteria

Third party requests contact PCORI

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No