Nocturnal Automated Versus Continuous Ambulatory Peritoneal Dialysis in Patients With End-Stage Kidney Disease: A Multicenter, Randomized, Open-Label, Crossover Non-Inferiority Trial

Detailed 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.

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