Kidney FailureNCT07922772
Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
A study testing Daily Peritoneal Dialysis and Days-off Peritoneal Dialysis in people with Kidney Failure, run by University of Michigan at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure
- What is being tested?
- Daily Peritoneal Dialysis and Days-off Peritoneal Dialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 10 sitesUnited States
- Study dates
- Feb 2027to Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites
University of Michigan
Ann Arbor, Michigan, 48109
Balazs Szamosfalvi, MD
Emory University
Atlanta, Georgia, 30322
Jason Cobb, MD
University of Indiana
Bloomington, Indiana, 47405
Nupur Gupta, MD
University of Texas Southwestern (UTSW)
Dallas, Texas, 75390
Northwestern University
Evanston, Illinois, 60208
Rogosin Institute, Inc (New York-Presbyterian Hospital/Weill Cornell Medicine)
New York, New York, 10021
Daniil Shimonov, MD
Mount Sinai School of Medicine (MSSM)
New York, New York, 10029
Sharma Shuchita, MD
University of Washington (UW)
Seattle, Washington, 98195
Rajnish Mehrotra, MD, MS
Lundquist Institute at Harbor-UCLA Medical Center
Torrance, California, 90502
Jenny Shen, MD
Wake Forest University School of Medicine (WFUSM)
Winston-Salem, North Carolina, 27109
Mariana Murea, MD
About this study
Official title: 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.
- Conditions
- Kidney Failure
- Being tested
- Daily Peritoneal Dialysis, Days-off Peritoneal Dialysis
- Keywords
- Peritoneal Dialysis
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Peritoneal DialysisProcedure or surgery
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.
Days-off Peritoneal DialysisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Daily Peritoneal Dialysis (7 days/week) | Active comparator | Approximately 225 participants Receives: Procedure: Daily Peritoneal Dialysis |
| Days-off Peritoneal Dialysis (5-6 days/week) | Experimental | Approximately 225 participants Receives: Procedure: Days-off Peritoneal Dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (start of randomized treatment) through Month 24 of follow-up
Secondary outcomes (9)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Day 1 through Month 24 of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startFeb 2027 (estimated)
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, non-inferiority pragmatic randomized controlled trial (RCT) to compare the effectiveness of days-off (5-6 days/week) versus daily (7 days/week) PD among adults with residual kidney function (RKF) initiating maintenance outpatient PD for kidney failure. 450 participants (225 per arm) will be randomized across up to 30 clinical sites. The trial includes an embedded qualitative and mixed methods design with interviews of a small subsample of participants and their care partners.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Bruce M Robinson, University of Michigan
- Investigators
- Bruce Robinson, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922772
- Sponsor's protocol ID
- HUM00302656
- Other IDs
- BPS-2025C1-44706
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data will be deposited in the Patient-Centered Outcomes Data Repository (PCODR) at ICPSR.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
- ClinicalTrials.gov ID
- NCT07922772
- Acronym / sponsor ID
- HUM00302656
- Conditions
- Kidney Failure
- Keywords
- Peritoneal Dialysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Feb 2027 (estimated)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, non-inferiority pragmatic randomized controlled trial (RCT) to compare the effectiveness of days-off (5-6 days/week) versus daily (7 days/week) PD among adults with residual kidney function (RKF) initiating maintenance outpatient PD for kidney failure. 450 participants (225 per arm) will be randomized across up to 30 clinical sites. The trial includes an embedded qualitative and mixed methods design with interviews of a small subsample of participants and their care partners.
| Arm | Type | Receives |
|---|---|---|
| Daily Peritoneal Dialysis (7 days/week) | Active comparator | Procedure: Daily Peritoneal DialysisApproximately 225 participants |
| Days-off Peritoneal Dialysis (5-6 days/week) | Experimental | Procedure: Days-off Peritoneal DialysisApproximately 225 participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Peritoneal DialysisAfter 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. | Procedure or surgery | Daily Peritoneal Dialysis (7 days/week) |
| Days-off Peritoneal DialysisAfter 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. | Procedure or surgery | Days-off Peritoneal Dialysis (5-6 days/week) |
Primary outcome
Total number of composite clinical events during follow up
Time frame: Day 1 (start of randomized treatment) through Month 24 of 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.
9 secondary outcomes
Standardized Outcomes in Nephrology - Life Participation (SONG-LP) score (Patient reported outcome)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Months 0, 3, 6, 12, and 24
Number of episodes of low small-solute clearance (weekly Kt/V [peritoneal + renal] < 1.7).
Time frame: Day 1 through Month 24 of follow-up
Number of episodes of serum potassium ≥ 6.0 mEq/L
Time frame: Day 1 through Month 24 of follow-up
Number of episodes of serum phosphate ≥ 7.0 mg/dL
Time frame: Day 1 through Month 24 of follow-up
Number of episodes of serum CO2 ≤17 mmol/L
Time frame: Day 1 through Month 24 of follow-up
Number of episodes of serum sodium < 130 mEq/L
Time frame: Day 1 through Month 24 of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified study data will be deposited in the Patient-Centered Outcomes Data Repository (PCODR) at ICPSR.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bruce Robinson, MD, MS principal investigator
University of Michigan
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Peritoneal Dialysis and Days-off Peritoneal Dialysis in people with Kidney Failure, run by University of Michigan at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Cawrse, MS (734-936-4888, cawrse@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of composite clinical events during follow up (time frame: Day 1 (start of randomized treatment) through Month 24 of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.