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

Primary Purpose

Kidney Failure,Chronic

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Huaren Peritoneal Dialysate
Baxter Peritoneal Dialysate
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure,Chronic focused on measuring CAPD, efficacy, safety, survival rate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Huaren peritoneal dialysate

Baxter Peritoneal Dialysate

Arm Description

Huaren Peritoneal dialysate CAPD 3-5 times/d

Baxter Peritoneal dialysate CAPD 3-5 times/d

Outcomes

Primary Outcome Measures

survival rate

Secondary Outcome Measures

PD technique survival rate
estimated glomerular filtration rate decline
nutritional status
quality of life(SF-36)
cardiovascular events
increments of dialysis dose
medical costs
dropout rate

Full Information

First Posted
January 29, 2013
Last Updated
March 9, 2022
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01779557
Brief Title
Safety and Effectiveness Evaluation of Two Kinds of Peritoneal Dialysate
Acronym
SEED
Official Title
The Prospective, Randomized, Parallel, Controlled, Multi-center Clinical Study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 2013 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
September 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure,Chronic
Keywords
CAPD, efficacy, safety, survival rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
750 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Huaren peritoneal dialysate
Arm Type
Experimental
Arm Description
Huaren Peritoneal dialysate CAPD 3-5 times/d
Arm Title
Baxter Peritoneal Dialysate
Arm Type
Active Comparator
Arm Description
Baxter Peritoneal dialysate CAPD 3-5 times/d
Intervention Type
Drug
Intervention Name(s)
Huaren Peritoneal Dialysate
Intervention Description
Huaren Peritoneal dialysate CAPD 3-5 times/d
Intervention Type
Drug
Intervention Name(s)
Baxter Peritoneal Dialysate
Intervention Description
Baxter Peritoneal dialysate CAPD 3-5 times/d
Primary Outcome Measure Information:
Title
survival rate
Time Frame
1,2,3,4,5 years
Secondary Outcome Measure Information:
Title
PD technique survival rate
Time Frame
1,2,3,4,5 years
Title
estimated glomerular filtration rate decline
Time Frame
1,2,3,4,5 years
Title
nutritional status
Time Frame
1,2,3,4,5 years
Title
quality of life(SF-36)
Time Frame
1,2,3,4,5 years
Title
cardiovascular events
Time Frame
1,2,3,4,5 years
Title
increments of dialysis dose
Time Frame
1,2,3,4,5 years
Title
medical costs
Time Frame
1,2,3,4,5 years
Title
dropout rate
Time Frame
1,2,3,4,5 years
Other Pre-specified Outcome Measures:
Title
AE, vital signs, laboratory tests
Time Frame
1,2,3,4,5 years
Title
peritonitis
Time Frame
1,2,3,4,5 years
Title
quality of products
Time Frame
1,2,3,4,5 years
Title
allergy to PD fluids, bags and tubes
Time Frame
1,2,3,4,5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHEN Xiangmei, yes
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26715594
Citation
Zhou J, Cao X, Lin H, Ni Z, He Y, Chen M, Zheng H, Chen X. Safety and effectiveness evaluation of a domestic peritoneal dialysis fluid packed in non-PVC bags: study protocol for a randomized controlled trial. Trials. 2015 Dec 29;16:592. doi: 10.1186/s13063-015-1131-1.
Results Reference
derived
Links:
URL
http://www.301hospital.com.cn/
Description
The official website of Chinese PLA General Hospital.

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Safety and Effectiveness Evaluation of Two Kinds of Peritoneal Dialysate

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