NCT05449067Completed
Nocturnal APD vs. CAPD in Non-diabetic ESKD
Nocturnal Automated Versus Continuous Ambulatory Peritoneal Dialysis in Patients With End-Stage Kidney Disease: A Multicenter, Randomized, Open-Label, Crossover Non-Inferiority Trial
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 137 (actual)
- First submitted
- 22 Jun 2022
- Start date
- 26 May 2022
- Primary completion date
- 11 Feb 2026
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Chronic kidney disease
- NCT number
- NCT05449067
What you commit to
- Study type: Interventional
- Participants enrolled: 137
- From 26 May 2022 to the primary completion date, 11 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Abdominal surgery other than PD catheter insertion in the past 3 months;
- Planned kidney transplant in the last 6 months;
Other illness
- Patients with diabetes mellitus;
- Combined with acute events of cardiovascular disease(CVD), cardiac function ≥ New York Heart Association (NYHA) class III;
- Active hepatitis, cirrhosis, psychiatric disease, malignancy, pregnancy.
Lab values
- Maintained peritoneal dialysis solution with a glucose concentration \>2.5%;
Other
- Episodes of peritonitis in the past 1 month;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.