NCT01637792

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2004

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

Study Start

First participant enrolled

June 1, 2004

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
Last Updated

July 22, 2016

Status Verified

July 1, 2016

Enrollment Period

6.2 years

First QC Date

July 1, 2012

Last Update Submit

July 20, 2016

Conditions

End Stage Renal DiseaseAnuriaPeritonitis

Keywords

peritoneal dialysisdoseresidual kidney functiontechnique survivalpatient survivalperitonitis

Outcome Measures

Primary Outcomes (1)

  • Residual kidney function including glomerular filtration rate (GFR), daily urine voume (Uvol), and anuria-free survival.

    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 Outcomes (3)

  • Number of participants having technique failure refering to switching to maintenance hemodialyisis

    Up to 24 months after CAPD initiation.

  • Number of participants died

    Up to 24 months after CAPD initiation

  • Episodes of peritonitis

    Up to 24 months after CAPD initiation

Study Arms (2)

Three 2-liter exchanges group

EXPERIMENTAL

A group of randomly assigned patients undergoing three 2-liter exchanges daily CAPD.

Other: Three 2-liter exchanges daily CAPD

Four 2-liter exchanges group

ACTIVE COMPARATOR

A group of randomly assigned patients undergoing four 2-liter exchanges daily CAPD.

Other: Four 2-liter exchanges daily CAPD

Interventions

Three 2-liter exchanges daily CAPDOTHER

CAPD regimen of three 2-liter daily exchanges

Also known as: small volume CAPD
Three 2-liter exchanges group
Four 2-liter exchanges daily CAPDOTHER

CAPD regimen of four 2-liter daily exchagnes

Also known as: standard volume CAPD
Four 2-liter exchanges group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University school of medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (4)

  • Lo WK, Jiang Y, Cheng SW, Cheng IK. Survival of CAPD patients in a center using three two-liter exchanges as standard regime. Perit Dial Int. 1996;16 Suppl 1:S163-6.

    PMID: 8728185BACKGROUND

  • Szeto CC, Lai KN, Yu AW, Leung CB, Ho KK, Mak TW, Li PK, Lam CW. Dialysis adequacy of Asian patients receiving small volume continuous ambulatory peritoneal dialysis. Int J Artif Organs. 1997 Aug;20(8):428-35.

    PMID: 9323505BACKGROUND

  • Fang W, Qian J, Lin A, Rowaie F, Ni Z, Yao Q, Bargman JM, Oreopoulos DG. Comparison of peritoneal dialysis practice patterns and outcomes between a Canadian and a Chinese centre. Nephrol Dial Transplant. 2008 Dec;23(12):4021-8. doi: 10.1093/ndt/gfn372. Epub 2008 Sep 12.

    PMID: 18790809BACKGROUND

  • Singhal MK, Bhaskaran S, Vidgen E, Bargman JM, Vas SI, Oreopoulos DG. Rate of decline of residual renal function in patients on continuous peritoneal dialysis and factors affecting it. Perit Dial Int. 2000 Jul-Aug;20(4):429-38.

    PMID: 11007375BACKGROUND

MeSH Terms

Conditions

Kidney Failure, ChronicAnuriaPeritonitis

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 SymptomsUrination DisordersIntraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System Diseases

Study Officials

  • Wei Fang, MD, PhD

    Renal Division, Renji Hospital, Shanghai Jiaotong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 1, 2012

First Posted

July 11, 2012

Study Start

June 1, 2004

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

July 22, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)