Safety and Effectiveness Evaluation of Two Kinds of Peritoneal Dialysate (SEED)

Chinese PLA General Hospital (301 Hospital)

Status and phase

Completed

Phase 4

Conditions

Kidney Failure,Chronic

Treatments

Drug: Baxter Peritoneal Dialysate

Drug: Huaren Peritoneal Dialysate

Study type

Interventional

Funder types

Other

Identifiers

NCT01779557

ChiCTR-TRC-13003001 (Registry Identifier)

HR-PD-2012

Details and patient eligibility

About

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.

Full 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.

Enrollment

750 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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