The prospective, randomized, parallel, controlled, multi-center clinical study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-13003001

Enrollment

Unknown

Registered

2013-01-15

Start date

2013-02-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Interventions

Experimental group:Huaren dialysate CAPD 3-5 times/d

Control group:Baxter Peritoneal Dialysate CAPD 3-5 times/d

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18, male or female; 2. ESRD patients; 3. Dialysis mode: CAPD; 4. Dialysis duration >=30 days and <=6 months; 5. Be capable of implementing home dialysis; 6. Diabetic nephropathy, 3ml/min<= residual renal GFR <=15ml/min; other renal diseases, 3ml/min<= residual renal GFR <=10ml/min; 7. Sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Acute renal failure; 2. Plan to kidney transplantation in 2 years; 3. Hemodialysis; 4. Exit site infection or tunnel infection; 5. Presenting 2/3 of the following: (1) abdomenal pain, turbid ascites, with or without fever; (2) drainage fluid WBC>100*10^6/L, neutrophil ratio>50%; (3) culture positive/ Gram stain positive in drainage fluid; 6. Anti-HIV positive; 7. Allergic to components of dialysate; 8. Active, residual malignant tumor, or systemic infection, liver cirrhosis, severe congestive heart failure, anemia (Hb 185cm or height =33kg/m2); 11. Poor compliance; 12. Pregnant or lactating, women of childbearing age do not agree to use effective contraceptive measures during the trial; 13. Has a history of alcoholism and drug abuse (defined as illegal drugs); 14. Any cirrcumstances when patients are believed unsuitable for this trial.

Design outcomes

Primary

Measure	Time frame
Survival rate;	—

Secondary

Measure	Time frame
Technical survival rate;Slope of residual renal GFR decline curve;SGA score;serum albumin;Quality of life assessment score(SF-36 scale);The incidence of cardiovascular events(sudden cardiac death, myocardial infarction, severe arrhythmia, Heart failure, carotid plaque formation rate);Change of dialysis dose from baseline to termination;Peritoneal dialysis related cost assessment;Drop out rate;	—

Countries

China

Contacts

Public ContactXiangmei Chen

xmchen301@126.com+86 010 66935462

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026