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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Validity and Security of 2500ml Huaren Peritoneal Dialysate: A Prospective, Randomized, Controlled, Multi-Center Clinical Trial

Conditions
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Disorders Associated With Peritoneal Dialysis

Intervention / Treatment
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* Other: 2500ml Huaren peritoneal dialysate
* Other: 2000ml peritoneal dialysate


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: The duration of PD is more than 1 month. The age is range from 18 to 80 years old. The patient can be treated with regular PD in home. The volume of peritoneal dialysate is from 8L to 10 L in 1 day. The patient can be visited regularly. The patient must be freely given informed consent Exclusion criteria: Peritonitis was happened within 1 month The KT/V<1.7 Infections in the exit or tunnel With tumors. With low transport of peritoneum. With mental and behavior disorders. With acute renal failure Hemodialysis meanwhile With heart failure( NYHA III-IV ) or cardio- cerebrovascular events Attending other clinical trails Refused to give informed consent Exit criteria （1）Stop PD for more than 10 days （2）The patient demand to quit from the RCT （3）With serious adverse events.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A 2500mlGroup<br>use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night | Other: 2500ml Huaren peritoneal dialysate<br>* use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night<br>|
| Active Comparator: B 2000mlGroup<br>use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night | Other: 2000ml peritoneal dialysate<br>* use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of dialysis (kt/v) | kt/v | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual kidney function (Residual kidney kt/v) | Residual kidney kt/v | up to 6 months | 
| Peritoneal function (Peritoneal equilibration test) | Peritoneal equilibration test | up to 6 months |