Kidney Failure,Chronic
Conditions
Keywords
CAPD, efficacy, safety, survival rate
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.
Interventions
DRUGHuaren Peritoneal Dialysate
Huaren Peritoneal dialysate CAPD 3-5 times/d
DRUGBaxter Peritoneal Dialysate
Baxter Peritoneal dialysate CAPD 3-5 times/d
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survival rate | 1,2,3,4,5 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| nutritional status | 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 |
Other
| Measure | Time frame |
|---|---|
| allergy to PD fluids, bags and tubes | 1,2,3,4,5 years |
| AE, vital signs, laboratory tests | 1,2,3,4,5 years |
| peritonitis | 1,2,3,4,5 years |
| quality of products | 1,2,3,4,5 years |
Countries
China
Outcome results
None listed