Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
NCT07922772, Not applicable, Not yet recruiting, University of Michigan
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Days-Off Versus Daily Initial Peritoneal Dialysis Prescription | ClinicalTrials.gov |
| NCT number | NCT07922772 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 450 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Michigan | ClinicalTrials.gov |
| Conditions | Kidney Failure | ClinicalTrials.gov |
| Interventions | Daily Peritoneal Dialysis, Days-off Peritoneal Dialysis | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Total number of composite clinical events during follow up | 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. | ClinicalTrials.gov |
| Secondary | Standardized Outcomes in Nephrology - Life Participation (SONG-LP) score (Patient reported outcome) | Months 0, 1, 3, 9, 12, 18, and 24; Key secondary outcome is Month 0 to Month 6. | 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). | ClinicalTrials.gov |
| Secondary | Illness Intrusiveness Ratings Scale (IIRS) score (Patient reported outcome) | Months 0, 1, 3, 6, 9, 12, 18, and 24 | 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). | ClinicalTrials.gov |
| Secondary | Kidney Disease Quality of Life 36-Item Short Form Summary Score (KDQOL-36 KSS) (Patient reported outcome) | Months 0, 3, 6, 12, and 24 | 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. | ClinicalTrials.gov |
| Secondary | Change in Kidney Disease Quality of Life 36-Item Short Form Survey (KDQOL-36) kidney disease-specific subscale scores (Patient reported outcome) | Months 0, 3, 6, 12, and 24 | 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. | ClinicalTrials.gov |
| Secondary | Number of episodes of low small-solute clearance (weekly Kt/V [peritoneal + renal] < 1.7). | Day 1 through Month 24 of follow-up | Counts, for episodes of weekly urea clearance (peritoneal + renal) normalized to total body water (Kt/V \[P+R\]) \< 1.7. | ClinicalTrials.gov |
| Secondary | Number of episodes of serum potassium ≥ 6.0 mEq/L | Day 1 through Month 24 of follow-up | Counts, for episodes of hyperkalemia, defined as serum potassium ≥6.0 mEq/L | ClinicalTrials.gov |
| Secondary | Number of episodes of serum phosphate ≥ 7.0 mg/dL | Day 1 through Month 24 of follow-up | Counts, for episodes of hyperphosphatemia, defined as serum phosphate ≥7.0 mg/dL | ClinicalTrials.gov |
| Secondary | Number of episodes of serum CO2 ≤17 mmol/L | Day 1 through Month 24 of follow-up | Counts, for episodes of serum total carbon dioxide (CO2; bicarbonate) ≤ 17 mmol/L | ClinicalTrials.gov |
| Secondary | Number of episodes of serum sodium < 130 mEq/L | Day 1 through Month 24 of follow-up | Counts, for episodes of hyponatremia, defined as serum sodium \< 130 mEq/L. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)