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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aiwu Lin, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01637792
First received: July 1, 2012
Last updated: July 20, 2016
Last verified: July 2016

July 1, 2012
July 20, 2016
June 2004
August 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
  • The changes in residual renal function including urine volume and residual glomerular filtration rate. [ Time Frame: Month 1 and 24 after CAPD initiation ] [ Designated as safety issue: No ]
  • Number of participants developing to anuria (permanently daily urine volume less than 200ml) [ Time Frame: Up to 24 months after CAPD initiation ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01637792 on ClinicalTrials.gov Archive Site
  • Number of participants having technique failure refering to switching to maintenance hemodialyisis [ Time Frame: Up to 24 months after CAPD initiation. ] [ Designated as safety issue: Yes ]
  • Number of participants died [ Time Frame: Up to 24 months after CAPD initiation ] [ Designated as safety issue: Yes ]
  • Episodes of peritonitis [ Time Frame: Up to 24 months after CAPD initiation ] [ Designated as safety issue: Yes ]
  • Number of participants having technique failure including death and switching to maintenance hemodialyisis [ Time Frame: Up to 24 months after CAPD initiation. ] [ Designated as safety issue: Yes ]
  • Episodes of peritonitis [ Time Frame: Up to 24 months after CAPD initiation ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD
Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD
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.
  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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • End Stage Renal Disease
  • Anuria
  • Peritonitis
  • Other: Three 2-liter exchanges daily CAPD
    CAPD regimen of three 2-liter daily exchanges
    Other Name: small volume CAPD
  • Other: Four 2-liter exchanges daily CAPD
    CAPD regimen of four 2-liter daily exchagnes
    Other Name: standard volume CAPD
  • Experimental: Three 2-liter exchanges group
    A group of randomly assigned patients undergoing three 2-liter exchanges daily CAPD.
    Intervention: Other: Three 2-liter exchanges daily CAPD
  • Active Comparator: Four 2-liter exchanges group
    A group of randomly assigned patients undergoing four 2-liter exchanges daily CAPD.
    Intervention: Other: Four 2-liter exchanges daily CAPD

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
139
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01637792
044119620, 07QA14040, 08DZ1900501
No
No
Not Provided
Aiwu Lin, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
Not Provided
Principal Investigator: Wei Fang, MD, PhD Renal Division, Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai Jiao Tong University School of Medicine
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP