Safety and Effectiveness Evaluation of Two Kinds of Peritoneal Dialysate

Phase 4

Completed

• Conditions: Kidney Failure,Chronic
• Interventions: Drug: Huaren Peritoneal Dialysate; Drug: Baxter Peritoneal Dialysate

• Registration Number: NCT01779557
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-30
• Study Start: 2013-02
• Primary Completion: 2019-10
• Study Completion: 2021-09
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Huaren peritoneal dialysate	Huaren Peritoneal Dialysate	Huaren Peritoneal dialysate CAPD 3-5 times/d
Baxter Peritoneal Dialysate	Baxter Peritoneal Dialysate	Baxter Peritoneal dialysate CAPD 3-5 times/d

Primary Outcome Measures

Name	Time	Method
survival rate	1,2,3,4,5 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China