A Controlled and Multi-Center Study of 2500ml Huaren Peritoneal Dialysate

Not Applicable

• Conditions: Disorders Associated With Peritoneal Dialysis
• Interventions: Other: 2000ml peritoneal dialysate; Other: 2500ml Huaren peritoneal dialysate

• Registration Number: NCT02393261
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of 2500ml Huaren Peritoneal Dialysate compared with normal 2000ml peritoneal dialysate.

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 most of them used imported dialysate, of which the price carried a great burden. Now, cheaper domestic dialysate is accessed to the ESRD patients in china, but the efficacy and safety of which are not fully clear. And according to researches from Hongkong, 6000ml of dialysate every day is able to. Thus, we presume 3 bags of 2500ml Huaren dialysate will satisfy the everyday need of an normal Asian. This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night, while those in control group will use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night for 12 weeks. After followed-up for 12 weeks, the adequacy of PD, residual kidney function , peritoneum function and QOL of patients will be evaluated.

Study Timeline

• Study Start: 2015-01
• Status Verified: 2015-03
• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-18
• Last Update Submitted: 2015-03-18
• Study First Posted: 2015-03-19
• Last Update Posted: 2015-03-19
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B 2000mlGroup	2000ml peritoneal dialysate	use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night
A 2500mlGroup	2500ml Huaren peritoneal dialysate	use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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