Nocturnal APD vs. CAPD in Non-diabetic ESKD

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.

Conditions

• End-Stage Kidney Disease
• Peritoneal Dialysis

Interventions

PROCEDURE

Nocturnal automated peritoneal dialysis (APD)

Nocturnal APD was delivered using automated cyclers (Dongze Medical, Fuzhou, China).During the night, a total of 4 exchanges were conducted, with 2000ml of dialysate infused into the abdominal cavity each time and retained for 2.5 hours, resulting in a total treatment duration of 10 hours; during the day, 2000ml of dialysate was retained.

PROCEDURE

Continuous Ambulatory Peritoneal Dialysis (CAPD)

CAPD was performed with three to five manual exchanges per day. Single intraperitoneal infusion of 2000ml of dialysate, with a single dwell time of 4 hours during the day; and a dwell time of 10-12 hours at night

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Fifth Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Fujian Provincial Hospital

  collaborator OTHER

• The Affiliated Ganzhou Hospital of Nanchang University

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• First People's Hospital of Yulin

  collaborator OTHER

• Dongguan Tungwah Hospital

  collaborator OTHER

• Guizhou Provincial People's Hospital

  collaborator OTHER

• The First People's Hospital of Nanning

  collaborator UNKNOWN

• Tianjin Medical University Second Hospital

  collaborator OTHER

• Guangzhou First People's Hospital

  collaborator OTHER

• Fuzhou First General Hospital Affiliated with Fujian Medical University

  collaborator UNKNOWN

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Fanfan Hou, MD,PhD · Nanfang Hospital, Southern Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-26

Primary Completion

2026-02-11

Completion

2026-02-11

Countries

• China

Study Locations