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Days-Off Versus Daily Initial Peritoneal Dialysis Prescription

2026年11月2日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

450

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Daily Peritoneal Dialysis (7 days/week)

Approximately 225 participants
程序：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.
实验性的：Days-off Peritoneal Dialysis (5-6 days/week)

Approximately 225 participants
程序：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Total number of composite clinical events during follow up
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Standardized Outcomes in Nephrology - Life Participation (SONG-LP) score (Patient reported outcome)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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).
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Michigan

合作者

Patient-Centered Outcomes Research Institute

调查人员

  • 首席研究员：Bruce Robinson, MD, MS、University of Michigan

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年2月1日

初级完成 (估计的)

2030年11月1日

研究完成 (估计的)

2030年11月1日

研究注册日期

首次提交

2026年11月2日

首先提交符合 QC 标准的

2026年11月2日

首次发布 (实际的)

2026年11月6日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HUM00302656
  • BPS-2025C1-44706 (其他赠款/资助编号：Patient-Centered Outcomes Research Institute)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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

IPD 共享时间框架

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

IPD 共享访问标准

Third party requests contact PCORI

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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