Overview

This trial is active, not recruiting.

Condition kidney failure,chronic
Treatments huaren peritoneal dialysate, baxter peritoneal dialysate
Phase phase 4
Sponsor Chinese PLA General Hospital
Start date February 2013
End date December 2018
Trial size 750 participants
Trial identifier NCT01779557, ChiCTR-TRC-13003001, HR-PD-2012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Huaren Peritoneal dialysate CAPD 3-5 times/d
huaren peritoneal dialysate
Huaren Peritoneal dialysate CAPD 3-5 times/d
(Active Comparator)
Baxter Peritoneal dialysate CAPD 3-5 times/d
baxter peritoneal dialysate
Baxter Peritoneal dialysate CAPD 3-5 times/d

Primary Outcomes

Measure
survival rate
time frame: 1,2,3,4,5 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Prospective, Randomized, Parallel, Controlled, Multi-center Clinical Study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Chinese PLA General Hospital.