Clinical trial NCT01779557: Safety and Effectiveness Evaluation of Two Kinds of Peritoneal Dialysate
Official title: The Prospective, Randomized, Parallel, Controlled, Multi-center Clinical Study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure,Chronic
Keywords: CAPD
efficacy
safety
survival rate
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2013-01-30
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: survival rate
timeFrame: 1,2,3,4,5 years
Secondary outcomes:
measure: PD technique survival rate
timeFrame: 1,2,3,4,5 years
measure: estimated glomerular filtration rate decline
timeFrame: 1,2,3,4,5 years
measure: nutritional status
timeFrame: 1,2,3,4,5 years
measure: quality of life(SF-36)
timeFrame: 1,2,3,4,5 years
measure: cardiovascular events
timeFrame: 1,2,3,4,5 years
measure: increments of dialysis dose
timeFrame: 1,2,3,4,5 years
measure: medical costs
timeFrame: 1,2,3,4,5 years
measure: dropout rate
timeFrame: 1,2,3,4,5 years
Other outcomes:
measure: AE, vital signs, laboratory tests
timeFrame: 1,2,3,4,5 years
measure: peritonitis
timeFrame: 1,2,3,4,5 years
measure: quality of products
timeFrame: 1,2,3,4,5 years
measure: allergy to PD fluids, bags and tubes
timeFrame: 1,2,3,4,5 years
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: CHEN Xiangmei, yes
role: STUDY_DIRECTOR
References:
citation: Zhou J, Cao X, Lin H, Ni Z, He Y, Chen M, Zheng H, Chen X. Safety and effectiveness evaluation of a domestic peritoneal dialysis fluid packed in non-PVC bags: study protocol for a randomized controlled trial. Trials. 2015 Dec 29;16:592. doi: 10.1186/s13063-015-1131-1.