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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Nicole Cawrse, MS
- 전화번호: 734-936-4888
- 이메일: cawrse@med.umich.edu
연구 장소
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California
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Torrance, California, 미국, 90502
- Lundquist Institute at Harbor-UCLA Medical Center
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수석 연구원:
- Jenny Shen, MD
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University
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수석 연구원:
- Jason Cobb, MD
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Illinois
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Evanston, Illinois, 미국, 60208
- Northwestern University
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Indiana
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Bloomington, Indiana, 미국, 47405
- University of Indiana
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수석 연구원:
- Nupur Gupta, MD
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- University of Michigan
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수석 연구원:
- Balazs Szamosfalvi, MD
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New York
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New York, New York, 미국, 10021
- Rogosin Institute, Inc (New York-Presbyterian Hospital/Weill Cornell Medicine)
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수석 연구원:
- Daniil Shimonov, MD
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New York, New York, 미국, 10029
- Mount Sinai School of Medicine (MSSM)
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수석 연구원:
- Sharma Shuchita, MD
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North Carolina
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Winston-Salem, North Carolina, 미국, 27109
- Wake Forest University School of Medicine (WFUSM)
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수석 연구원:
- Mariana Murea, MD
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Texas
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Dallas, Texas, 미국, 75390
- University of Texas Southwestern (UTSW)
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Washington
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Seattle, Washington, 미국, 98195
- University of Washington (UW)
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수석 연구원:
- Rajnish Mehrotra, MD, MS
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: 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. |
|
실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Total number of composite clinical events during follow up
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Standardized Outcomes in Nephrology - Life Participation (SONG-LP) score (Patient reported outcome)
기간: 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.
|
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Illness Intrusiveness Ratings Scale (IIRS) score (Patient reported outcome)
기간: 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)
기간: 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
|
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Change in Kidney Disease Quality of Life 36-Item Short Form Survey (KDQOL-36) kidney disease-specific subscale scores (Patient reported outcome)
기간: 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
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Number of episodes of low small-solute clearance (weekly Kt/V [peritoneal + renal] < 1.7).
기간: Day 1 through Month 24 of follow-up
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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
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Number of episodes of serum potassium ≥ 6.0 mEq/L
기간: 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
기간: 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
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Number of episodes of serum CO2 ≤17 mmol/L
기간: 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
기간: 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
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Bruce Robinson, MD, MS, University of Michigan
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- HUM00302656
- BPS-2025C1-44706 (기타 보조금/기금 번호: Patient-Centered Outcomes Research Institute)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
De-identified study data will be deposited in the Patient-Centered Outcomes Data Repository (PCODR) at ICPSR.
IPD 공유 기간
From date of final research report submission to PCORI for at least 7 years.
IPD 공유 액세스 기준
Third party requests contact PCORI
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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