CAPD Versus APD in Nondiabetic Peritoneal Dialysis Patients

Peritoneal Dialysis Clinical Trial

Official title: The Effectiveness of CAPD Versus APD in Nondiabetic Peritoneal Dialysis Patients: A Multi-center, Randomized, Crossover Study

Status Recruiting

Clinical Trial Summary

Background: Continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD) are two important PD modalities. To date, only three small sample randomized control trials(RCTs) comparing CAPD and APD have been conducted but yield inconsistent results.

Objective: Investigators plan to initiate a multicenter, prospective, randomized cross-over study to compare the quality of life and dialysis adequacy in non-diabetic PD patients.

Hypothesis: Patients' quality of life and dialysis adequacy on APD is no worse than on CAPD.

Methods: This study plans to recruit 268 non-diabetic patients on maintenance peritoneal dialysis. Patients will randomly be assigned into groups A and B in a 1:1 ratio: group A receives APD from week 1 to 12 and changes to CAPD from week 13 to 24; group B receives CAPD from week 1 to 12 and changes to APD from week 13 to 24. Outcomes were evaluated at week 12 and week 24.

Clinical Trial Description

This multicenter, randomized, open-label, crossover trial plans to recruit non-diabetic peritoneal dialysis patients by trained investigators according to the inclusion and exclusion criteria. At the beginning of the recruitment visit, each participant is asked to provide written informed consent in compliance with the Declaration of Helsinki and the requirements of the Independent Ethics Committee, after a careful explanation of the purpose and the procedures of the trial. Instructions for manual fluid exchange and automated peritoneal dialysis machines will be provided for each eligible patient, and they will be randomly assigned (1:1) to receive 12-week treatment in group A (APD-CCPD) and group B (CAPD), followed by a subsequent switch to the other modality. Safety assessments and routine visits were performed every 4 weeks thereafter, and efficacy assessments were performed at week 12 and week 24.

For the primary efficacy endpoint (the difference of Kt/V compared with baseline 3 months after treatment), 172 patients could provide 80% power to detect an absolute difference of 0.27 (10% of the mean) with a common SD of 0.46 (30% of the mean) at one-sided a=0.025. For another endpoint (the quality of life), previous studies have shown that the mean of a physical composite summary(PCS) score or a mental composite summary (MCS) score in the American population is about 50 points (SD=10), and a 2-point change in PCS or MCS is considered to be clinically significant. In this non-inferiority study, 196 patients could provide 80% power to detect an absolute difference of 4 points in mean change of PCS/MCS between groups at one-sided a=0.025. Considering the 10% rate of loss to follow-up, the sample size of each group was finally determined to be 108 cases. ;

Related Conditions & MeSH terms

• Peritoneal Dialysis

• NCT number: NCT05449067
• Study type: Interventional
• Source: Nanfang Hospital, Southern Medical University
• Contact: Fanfan Hou, MD,PhD
• Phone: +86-020-61641591
• Email: ffhouguangzhou@163.com
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2022
• Completion date: December 2024