Safety and Effectiveness Evaluation of Two Kinds of Peritoneal Dialysate

Kidney Failure,Chronic Clinical Trial

— SEED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779557
• Other study ID #: HR-PD-2012
• Secondary ID: ChiCTR-TRC-13003
• Status: Completed
• Phase: Phase 4
• Start date: February 2013
• Est. completion date: September 2021

Study information

• Verified date: March 2022
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: September 2021
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Kidney Failure,Chronic
• Renal Insufficiency

Intervention

Drug:
• Huaren Peritoneal Dialysate
Huaren Peritoneal dialysate CAPD 3-5 times/d
• Baxter Peritoneal Dialysate
Baxter Peritoneal dialysate CAPD 3-5 times/d

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	AE, vital signs, laboratory tests		1,2,3,4,5 years
Other	peritonitis		1,2,3,4,5 years
Other	quality of products		1,2,3,4,5 years
Other	allergy to PD fluids, bags and tubes		1,2,3,4,5 years
Primary	survival rate		1,2,3,4,5 years
Secondary	PD technique survival rate		1,2,3,4,5 years
Secondary	estimated glomerular filtration rate decline		1,2,3,4,5 years
Secondary	nutritional status		1,2,3,4,5 years
Secondary	quality of life(SF-36)		1,2,3,4,5 years
Secondary	cardiovascular events		1,2,3,4,5 years
Secondary	increments of dialysis dose		1,2,3,4,5 years
Secondary	medical costs		1,2,3,4,5 years
Secondary	dropout rate		1,2,3,4,5 years

External Links

•   The official website of Chinese PLA General Hospital.