CompletedNot Applicable

Nocturnal APD vs. CAPD in Non-diabetic ESKD

China137 participantsStarted 2022-05-26

Plain-language summary

Background: Continuous ambulatory peritoneal dialysis (CAPD) imposes a substantial daytime burden. Nocturnal automated peritoneal dialysis (APD) may improve patient-centered outcomes, but high-quality evidence is lacking. We aimed to determine whether nocturnal APD is non-inferior to CAPD in solute clearance and to evaluate patient-centered outcomes. Design: A multicenter, randomized, open-label, crossover non-inferiority trial. Primary Objective: To compare the adequacy of peritoneal dialysis between nocturnal APD and CAPD in non-diabetic patients. Secondary Objective: To compare the effects of nocturnal APD and CAPD on the quality of life, social functioning, sleep quality, blood pressure, and daily ultrafiltration volume. Hypothesis: In non-diabetic patients, nocturnal APD is non-inferior to CAPD in peritoneal dialysis adequacy. Methods:Eligible participants were randomly assigned in a 1:1 ratio to one of two treatment groups using a centralized block randomization system, stratified by study center. Group A consisted of 12 weeks of nocturnal APD followed by 12 weeks of CAPD; Group B consisted of the reverse order. The randomization code was generated by an independent statistical center. The trial comprised a screening period, two 12-week treatment periods, and a follow-up period. After screening and baseline assessments, participants initiated their assigned treatment sequence. Scheduled outpatient visits occurred every 4 weeks (±5 days) for safety monitoring and routine laboratory testing. Comprehensive outcome assessments were performed at week 12 (end of the first period) and week 24 (end of the second period). Additional unscheduled visits were arranged as needed in the event of adverse events or clinical changes.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 18 to 75 years;
. Maintenance peritoneal dialysis for ≥ 1 month;
. Weekly total CrCl ≥ 45 liters/week/1.73m2 body surface area;
. Total weekly Kt/V ≥ 1.7.

Exclusion criteria

. Patients with diabetes mellitus;
. Maintained peritoneal dialysis solution with a glucose concentration \>2.5%;
. Combined with acute events of cardiovascular disease(CVD), cardiac function ≥ New York Heart Association (NYHA) class III;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compared nocturnal automated peritoneal dialysis (APD) to continuous ambulatory peritoneal dialysis (CAPD) — given my specific situation, which of these two approaches does my doctor think would be more practical for my daily life and sleep schedule?
2Since this trial measured Total Weekly Kt/V as its main outcome, can my doctor explain what that number means for me personally and how it reflects whether my dialysis is actually clearing enough waste from my body?
3The trial was completed — has my doctor seen or reviewed the results yet, and do the findings suggest any meaningful difference in dialysis adequacy between the nocturnal APD and CAPD approaches for non-diabetic patients like me?
4Because this study focused specifically on non-diabetic end-stage kidney disease patients, would my doctor consider my individual health profile — including any other conditions I have — when deciding whether these results are relevant to my care?
5Before considering either of these peritoneal dialysis methods, should I discuss whether standard hemodialysis might be a better starting point for me, and what factors would make one option preferable over the others?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total Weekly Kt/V

Timeframe: Week 0, 4, 8, 12, 16, 20, and 24

Trial details

NCT IDNCT05449067

SponsorNanfang Hospital, Southern Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-11

View on ClinicalTrials.gov More End-Stage Kidney Disease trials