SEED: Safety and Effectiveness Evaluation of Two Kinds of Peritoneal Dialysate

Sponsor

Chinese PLA General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01779557

Collaborator

(none)

750

Enrollment

Location

Arms

103

Actual Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure,Chronic	Drug: Huaren Peritoneal Dialysate Drug: Baxter Peritoneal Dialysate	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

750 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Prospective, Randomized, Parallel, Controlled, Multi-center Clinical Study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate

Actual Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Oct 1, 2019

Actual Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Huaren peritoneal dialysate Huaren Peritoneal dialysate CAPD 3-5 times/d	Drug: Huaren Peritoneal Dialysate Huaren Peritoneal dialysate CAPD 3-5 times/d
Active Comparator: Baxter Peritoneal Dialysate Baxter Peritoneal dialysate CAPD 3-5 times/d	Drug: Baxter Peritoneal Dialysate Baxter Peritoneal dialysate CAPD 3-5 times/d

Arm

Intervention/Treatment

Experimental: Huaren peritoneal dialysate

Huaren Peritoneal dialysate CAPD 3-5 times/d

Drug: Huaren Peritoneal Dialysate

Huaren Peritoneal dialysate CAPD 3-5 times/d

Active Comparator: Baxter Peritoneal Dialysate

Baxter Peritoneal dialysate CAPD 3-5 times/d

Drug: Baxter Peritoneal Dialysate

Baxter Peritoneal dialysate CAPD 3-5 times/d

Outcome Measures

Primary Outcome Measures

survival rate [1,2,3,4,5 years]

Secondary Outcome Measures

PD technique survival rate [1,2,3,4,5 years]
estimated glomerular filtration rate decline [1,2,3,4,5 years]
nutritional status [1,2,3,4,5 years]
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]

Other Outcome Measures

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]
allergy to PD fluids, bags and tubes [1,2,3,4,5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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