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NCT Number: NCT01779557

Safety and Effectiveness Evaluation of Two Kinds of Peritoneal Dialysate

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Huaren Peritoneal Dialysate

Drug

Huaren Peritoneal dialysate CAPD 3-5 times/d

Baxter Peritoneal Dialysate

Drug

Baxter Peritoneal dialysate CAPD 3-5 times/d

Primary outcomes

  1. survival rate

    Time frame: 1,2,3,4,5 years

Secondary outcomes

  1. PD technique survival rate

    Time frame: 1,2,3,4,5 years

  2. estimated glomerular filtration rate decline

    Time frame: 1,2,3,4,5 years

  3. nutritional status

    Time frame: 1,2,3,4,5 years

  4. quality of life(SF-36)

    Time frame: 1,2,3,4,5 years

  5. cardiovascular events

    Time frame: 1,2,3,4,5 years

  6. increments of dialysis dose

    Time frame: 1,2,3,4,5 years

  7. medical costs

    Time frame: 1,2,3,4,5 years

  8. dropout rate

    Time frame: 1,2,3,4,5 years

Other outcomes

  1. AE, vital signs, laboratory tests

    Time frame: 1,2,3,4,5 years

  2. peritonitis

    Time frame: 1,2,3,4,5 years

  3. quality of products

    Time frame: 1,2,3,4,5 years

  4. allergy to PD fluids, bags and tubes

    Time frame: 1,2,3,4,5 years

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

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

Acronym: SEED

Important dates

Study start
2013
Primary completion
2019
Study completion
2021
First posted
Jan 30, 2013
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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