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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Nicole Cawrse, MS
- Numéro de téléphone: 734-936-4888
- E-mail: cawrse@med.umich.edu
Lieux d'étude
-
-
California
-
Torrance, California, États-Unis, 90502
- Lundquist Institute at Harbor-UCLA Medical Center
-
Chercheur principal:
- Jenny Shen, MD
-
-
Georgia
-
Atlanta, Georgia, États-Unis, 30322
- Emory University
-
Chercheur principal:
- Jason Cobb, MD
-
-
Illinois
-
Evanston, Illinois, États-Unis, 60208
- Northwestern University
-
-
Indiana
-
Bloomington, Indiana, États-Unis, 47405
- University of Indiana
-
Chercheur principal:
- Nupur Gupta, MD
-
-
Michigan
-
Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan
-
Chercheur principal:
- Balazs Szamosfalvi, MD
-
-
New York
-
New York, New York, États-Unis, 10021
- Rogosin Institute, Inc (New York-Presbyterian Hospital/Weill Cornell Medicine)
-
Chercheur principal:
- Daniil Shimonov, MD
-
New York, New York, États-Unis, 10029
- Mount Sinai School of Medicine (MSSM)
-
Chercheur principal:
- Sharma Shuchita, MD
-
-
North Carolina
-
Winston-Salem, North Carolina, États-Unis, 27109
- Wake Forest University School of Medicine (WFUSM)
-
Chercheur principal:
- Mariana Murea, MD
-
-
Texas
-
Dallas, Texas, États-Unis, 75390
- University of Texas Southwestern (UTSW)
-
-
Washington
-
Seattle, Washington, États-Unis, 98195
- University of Washington (UW)
-
Chercheur principal:
- Rajnish Mehrotra, MD, MS
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Daily Peritoneal Dialysis (7 days/week)
Approximately 225 participants |
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. |
|
Expérimental: Days-off Peritoneal Dialysis (5-6 days/week)
Approximately 225 participants |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total number of composite clinical events during follow up
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Standardized Outcomes in Nephrology - Life Participation (SONG-LP) score (Patient reported outcome)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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).
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Bruce Robinson, MD, MS, University of Michigan
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HUM00302656
- BPS-2025C1-44706 (Autre subvention/numéro de financement: Patient-Centered Outcomes Research Institute)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
De-identified study data will be deposited in the Patient-Centered Outcomes Data Repository (PCODR) at ICPSR.
Délai de partage IPD
From date of final research report submission to PCORI for at least 7 years.
Critères d'accès au partage IPD
Third party requests contact PCORI
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .