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Days-Off Versus Daily Initial Peritoneal Dialysis Prescription

2 listopada 2026 zaktualizowane przez: Bruce M Robinson, University of Michigan

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

450

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Daily Peritoneal Dialysis (7 days/week)

Approximately 225 participants
Procedura: 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.
Eksperymentalny: Days-off Peritoneal Dialysis (5-6 days/week)

Approximately 225 participants
Procedura: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Total number of composite clinical events during follow up
Ramy czasowe: 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.
Day 1 (start of randomized treatment) through Month 24 of follow-up

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Standardized Outcomes in Nephrology - Life Participation (SONG-LP) score (Patient reported outcome)
Ramy czasowe: 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).
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)
Ramy czasowe: 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).
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)
Ramy czasowe: 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.
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)
Ramy czasowe: 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.
Months 0, 3, 6, 12, and 24
Number of episodes of low small-solute clearance (weekly Kt/V [peritoneal + renal] < 1.7).
Ramy czasowe: 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.
Day 1 through Month 24 of follow-up
Number of episodes of serum potassium ≥ 6.0 mEq/L
Ramy czasowe: Day 1 through Month 24 of follow-up

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
Ramy czasowe: Day 1 through Month 24 of follow-up

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
Ramy czasowe: Day 1 through Month 24 of follow-up

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
Ramy czasowe: Day 1 through Month 24 of follow-up

Counts, for episodes of hyponatremia, defined as serum sodium < 130 mEq/L.
Day 1 through Month 24 of follow-up

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Michigan

Współpracownicy

Patient-Centered Outcomes Research Institute

Śledczy

  • Główny śledczy: Bruce Robinson, MD, MS, University of Michigan

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lutego 2027

Zakończenie podstawowe (Szacowany)

1 listopada 2030

Ukończenie studiów (Szacowany)

1 listopada 2030

Daty rejestracji na studia

Pierwszy przesłany

2 listopada 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 listopada 2026

Pierwszy wysłany (Rzeczywisty)

6 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • HUM00302656
  • BPS-2025C1-44706 (Inny numer grantu/finansowania: Patient-Centered Outcomes Research Institute)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Ramy czasowe udostępniania IPD

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

Kryteria dostępu do udostępniania IPD

Third party requests contact PCORI

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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