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

March 9, 2022 updated by: Chen Xiangmei, Chinese PLA General Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

750

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
survival rate
Time Frame: 1,2,3,4,5 years
1,2,3,4,5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
PD technique survival rate
Time Frame: 1,2,3,4,5 years
1,2,3,4,5 years
estimated glomerular filtration rate decline
Time Frame: 1,2,3,4,5 years
1,2,3,4,5 years
nutritional status
Time Frame: 1,2,3,4,5 years
1,2,3,4,5 years
quality of life(SF-36)
Time Frame: 1,2,3,4,5 years
1,2,3,4,5 years
cardiovascular events
Time Frame: 1,2,3,4,5 years
1,2,3,4,5 years
increments of dialysis dose
Time Frame: 1,2,3,4,5 years
1,2,3,4,5 years
medical costs
Time Frame: 1,2,3,4,5 years
1,2,3,4,5 years
dropout rate
Time Frame: 1,2,3,4,5 years
1,2,3,4,5 years

Other Outcome Measures

Outcome Measure
Time Frame
AE, vital signs, laboratory tests
Time Frame: 1,2,3,4,5 years
1,2,3,4,5 years
peritonitis
Time Frame: 1,2,3,4,5 years
1,2,3,4,5 years
quality of products
Time Frame: 1,2,3,4,5 years
1,2,3,4,5 years
allergy to PD fluids, bags and tubes
Time Frame: 1,2,3,4,5 years
1,2,3,4,5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2013

Primary Completion (ACTUAL)

October 1, 2019

Study Completion (ACTUAL)

September 1, 2021

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (ESTIMATE)

January 30, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR-PD-2012
  • ChiCTR-TRC-13003001 (REGISTRY: Chinese Clinial Trial Registry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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