A Study of Domestic Automated Peritoneal Dialysis Machine

Not Applicable

• Conditions: Disorders Associated With Peritoneal Dialysis
• Interventions: Other: APD; Other: CAPD

• Registration Number: NCT02388945
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of domestic APD machine compared with the patients followed CAPD.

Detailed Description

Peritoneal dialysis (PD) is one of important way of renal replacement treatment worldwide. In China, about 40,000 patients suffered from end stage renal disease treated with PD, and almost of them followed continuous ambulatory peritoneal dialysis (CAPD) because of the expensive price of import automated PD (APD) machines although the higher clearance of solute, lower rate of PD related peritonitis and higher quality of life (QOL) in patients treated with APD compared those with CAPD. Now, cheaper domestic APD machines ( PDGO, Fuzhou, China) are accessed to the ESRD patients in china, but the efficacy and safety of which are not fully clear. This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will receive APD while those in control group will receive CAPD for 8 weeks. After followed-up for 8 weeks, the adequacy of PD, residual kidney function , peritoneum function and QOL of patients will be evaluated.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-15
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-09
• Last Update Submitted: 2015-03-09
• Study First Posted: 2015-03-17
• Last Update Posted: 2015-03-17
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A APDGroup	APD	PDGO APD machines used in the PD patients for 8 weeks
B CAPDGroup	CAPD	CAPD used in the PD Patients for 8 weeks

Primary Outcome Measures

Name	Time	Method
Adequacy of dialysis	up to 8 weeks	kt/v

Secondary Outcome Measures

Name	Time	Method
Residual kidney function	up to 6 months	Residual kidney kt/v
Peritoneal function	up to 6 months	Peritoneal equilibration test

Trial Locations

Locations (1)

Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China