Safety and Effectiveness Evaluation of Two Kinds of Peritoneal Dialysate

Study Overview
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Brief Summary
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This study is to evaluate the effectiveness and safety of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate, investigate the proper dialysis dose for Chinese CAPD patients.

Detailed Description
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This study is a prospective, randomized, parallel, controlled, multi-center clinical study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate.It aims to investigate the proper dialysis dose for Chinese CAPD patients.At the same time,it can evaluate the effectiveness and safety of Chinese product Huaren Peritoneal Dialysate and peritoneal dialysis product Baxter Peritoneal Dialysate.

Official Title
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The Prospective, Randomized, Parallel, Controlled, Multi-center Clinical Study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate

Conditions
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Kidney Failure,Chronic

Intervention / Treatment
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* Drug: Huaren Peritoneal Dialysate
* Drug: Baxter Peritoneal Dialysate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18, male or female Patients with end stage renal diseases Dialysis mode: CAPD Dialysis duration:≥30 days and ≤6 months Be capable of implementing home dialysis Diabetic nephropathy, 3ml/min≤ residual renal GFR ≤15ml/min; other renal diseases, 3ml/min≤ residual renal GFR ≤10ml/min Sign the written informed consent Exclusion Criteria: Acute renal failure Planing to receive kidney transplantation in 2 years Hemodialysis Exit site infection or tunnel infection Presenting 2/3 of the following: a. abdominal pain, turbid ascites, with or without fever; b. drainage fluid WBC>100×106/L, neutrophil ratio>50%; c.culture positive/ Gram stain positive in drainage fluid; Anti-HIV positive Allergic to components of dialysate Active, residual malignant tumor, or systemic infection, liver cirrhosis, severe congestive heart failure, anemia（Hb<80g/L）,malnutrition（Serum Alb<28g/L）,refractory hypertension Identified peritoneal high transportation by peritoneal equilibration test (PET) Extreme body shape (height> 185cm or height <145cm), obesity (BMI ≥ 33kg/m2) Poor compliance Pregnant or lactating, women of childbearing age do not agree to use effective contraceptive measures during the trial Has a history of alcoholism and drug abuse (defined as illegal drugs) Any circumstances when patients are believed unsuitable for this trial

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Huaren peritoneal dialysate<br>Huaren Peritoneal dialysate CAPD 3-5 times/d | Drug: Huaren Peritoneal Dialysate<br>* Huaren Peritoneal dialysate CAPD 3-5 times/d<br>|
| Active Comparator: Baxter Peritoneal Dialysate<br>Baxter Peritoneal dialysate CAPD 3-5 times/d | Drug: Baxter Peritoneal Dialysate<br>* Baxter Peritoneal dialysate CAPD 3-5 times/d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate |  | 1,2,3,4,5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD technique survival rate |  | 1,2,3,4,5 years | 
| estimated glomerular filtration rate decline |  | 1,2,3,4,5 years | 
| nutritional status |  | 1,2,3,4,5 years | 
| quality of life(SF-36) |  | 1,2,3,4,5 years | 
| cardiovascular events |  | 1,2,3,4,5 years | 
| increments of dialysis dose |  | 1,2,3,4,5 years | 
| medical costs |  | 1,2,3,4,5 years | 
| dropout rate |  | 1,2,3,4,5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAPD, efficacy, safety, survival rate