An interventional study of Daily Peritoneal Dialysis and Days-off Peritoneal Dialysis in Kidney Failure, sponsored by University of Michigan. Not yet recruiting at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
1,409 studies on the registry are indexed under Renal Insufficiency; 143 are open to participants now.
This study's planned enrollment of 450 is above the median of 40 across 1,058 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately 225 participants
Procedure: Daily Peritoneal Dialysis
Approximately 225 participants
Procedure: Days-off 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.
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.
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.
Time frame: Day 1 (start of randomized treatment) through Month 24 of follow-up
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).
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)
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).
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)
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.
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)
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Day 1 through Month 24 of follow-up
Plan to share: Yes — De-identified study data will be deposited in the Patient-Centered Outcomes Data Repository (PCODR) at ICPSR.
Supporting information: Study protocol
Time frame: From date of final research report submission to PCORI for at least 7 years.
Access criteria: Third party requests contact PCORI
Data sharing details ↗ · www.icpsr.umich.edu
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Nov 2030, 45 months later.
Of 118 non-industry interventional studies with no phase under Renal Insufficiency, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 49. This study's planned 45 months is above that.
Counting every sponsor, half of 149 studies reached it within 22 months; a quarter within 8 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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