NCT01779557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

6.7 years

First QC Date

January 29, 2013

Last Update Submit

March 9, 2022

Conditions

Kidney Failure,Chronic

Keywords

CAPDefficacysafetysurvival rate

Outcome Measures

Primary Outcomes (1)

  • survival rate

    1,2,3,4,5 years

Secondary Outcomes (8)

  • PD technique survival rate

    1,2,3,4,5 years

  • estimated glomerular filtration rate decline

    1,2,3,4,5 years

  • nutritional status

    1,2,3,4,5 years

  • quality of life(SF-36)

    1,2,3,4,5 years

  • cardiovascular events

    1,2,3,4,5 years

  • +3 more secondary outcomes

Other Outcomes (4)

  • AE, vital signs, laboratory tests

    1,2,3,4,5 years

  • peritonitis

    1,2,3,4,5 years

  • quality of products

    1,2,3,4,5 years

  • +1 more other outcomes

Study Arms (2)

Huaren peritoneal dialysate

EXPERIMENTAL

Huaren Peritoneal dialysate CAPD 3-5 times/d

Drug: Huaren Peritoneal Dialysate

Baxter Peritoneal Dialysate

ACTIVE COMPARATOR

Baxter Peritoneal dialysate CAPD 3-5 times/d

Drug: Baxter Peritoneal Dialysate

Interventions

Huaren Peritoneal DialysateDRUG

Huaren Peritoneal dialysate CAPD 3-5 times/d

Huaren peritoneal dialysate
Baxter Peritoneal DialysateDRUG

Baxter Peritoneal dialysate CAPD 3-5 times/d

Baxter Peritoneal Dialysate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (1)

  • 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.

    PMID: 26715594DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • CHEN Xiangmei, yes

    Chinese PLA General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Chief physician, Academician of Chinese Academy of Engineering

Study Record Dates

First Submitted

January 29, 2013

First Posted

January 30, 2013

Study Start

February 1, 2013

Primary Completion

October 1, 2019

Study Completion

September 1, 2021

Last Updated

March 10, 2022

Record last verified: 2022-03

Locations

CN(1)