Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD

July 20, 2016 updated by: Aiwu Lin, Shanghai Jiao Tong University School of Medicine
The purpose of this study was to explore the impacts of different continuous ambulatory peritoneal dialysis (CAPD) dosage (three 2-Liter exchanges CAPD vs. four 2-Liter exchanges CAPD) on residual kidney function, technique survival, patient survival, and peritonitis in incident Chinese peritoneal dialysis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. The primary end point for this study was changes in residual kidney function including GFR, daily urine volume (Uvol), and anuria-free survival. GFR and Uvol were evaluated within 1 week before CAPD initiation (the baseline), and then at month 1, 6, 12, 18 and 24. At the same time, body weight, blood pressure, daily net ultrafiltration, dialysis adequacy, peritoneal solute transport rate, and biochemical parameters etc. were assessed. Once an episode of peritonitis or other serious reversible intercurrent illness occurred, all the assessments were delayed one month after being cured. Anuria was termed by daily Uvol permanently less than 100 ml.
  2. The secondary end points included technique survival, patient survival and peritonitis. Technique failure was defined as switching to maintenance hemodialysis.

Study Type

Interventional

Enrollment (Actual)

139

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
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • incident CAPD patients aged 18 to 80 years
  • GFR ≥ 2 ml/min and Uvol ≥ 500 ml/day

Exclusion Criteria:

  • have a history of maintenance hemodialysis or renal transplantation
  • anticipated life expectancy less than 6 months
  • with active malignancy, acute infection, significant heart failure or in other severe conditions
  • unable to give informed consent

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Three 2-liter exchanges group
A group of randomly assigned patients undergoing three 2-liter exchanges daily CAPD.
Other: Three 2-liter exchanges daily CAPD
CAPD regimen of three 2-liter daily exchanges
Other Names:
  • small volume CAPD
Active Comparator: Four 2-liter exchanges group
A group of randomly assigned patients undergoing four 2-liter exchanges daily CAPD.
Other: Four 2-liter exchanges daily CAPD
CAPD regimen of four 2-liter daily exchagnes
Other Names:
  • standard volume CAPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual kidney function including glomerular filtration rate (GFR), daily urine voume (Uvol), and anuria-free survival.
Time Frame: Up to 24 months after CAPD initiation
GFR was calculated by the mean of renal clearance of urea and creatinine from a 24-h urine collection. Anuria was termed as consistently Uvol < 100 ml/day for more than a month.
Up to 24 months after CAPD initiation

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants having technique failure refering to switching to maintenance hemodialyisis
Time Frame: Up to 24 months after CAPD initiation.
Up to 24 months after CAPD initiation.
Number of participants died
Time Frame: Up to 24 months after CAPD initiation
Up to 24 months after CAPD initiation
Episodes of peritonitis
Time Frame: Up to 24 months after CAPD initiation
Up to 24 months after CAPD initiation

Collaborators and Investigators

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

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Wei Fang, MD, PhD, Renal Division, Renji Hospital, Shanghai Jiaotong University School of Medicine

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

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

June 1, 2004

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

July 1, 2012

First Submitted That Met QC Criteria

July 8, 2012

First Posted (Estimate)

July 11, 2012

Study Record Updates

Last Update Posted (Estimate)

July 22, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 044119620
  • 07QA14040 (Other Grant/Funding Number: Science and Technology Commission of Shanghai Municipality)
  • 08DZ1900501 (Other Grant/Funding Number: Science and Technology Commission of Shanghai Municipality)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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