NCT01056835

Brief Summary

The purpose of this study is to evaluate the effect of Prostaglandin I2 analogue use on the development of chronic allograft nephropathy and changes in allograft function in prevalent renal transplant recipients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_3

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, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

4.5 years

First QC Date

January 24, 2010

Last Update Submit

May 24, 2015

Conditions

Chronic Allograft Nephropathy

Outcome Measures

Primary Outcomes (1)

  • graft pathology, serum creatinine, creatinine clearance, eGFR

    1 year after drug administration

Study Arms (1)

control

NO INTERVENTION
Drug: prostaglandin I2 analogue

Interventions

prostaglandin I2 analogueDRUG
control

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • prevalent renal transplant recipients 2 years after transplantation
  • no history of acute rejection
  • stable renal function

You may not qualify if:

  • history of biopsy-proven chronic allograft nephropathy
  • history of biopsy-proven CNI nephrotoxicity
  • history of biopsy-proven or clinical acute rejection
  • unstable trough level of CNI or extremely low level of CNI
  • bleeding tendency(+)
  • pregnancy or pregnant-willing
  • anticoagulation(+)
  • antiplatelet agent (+)
  • significant comorbidity(+): Acute coronary syndrome, pneumonia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Study Officials

  • Jongwon Ha, MD, PhD

    Seoul National University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 24, 2010

First Posted

January 26, 2010

Study Start

June 1, 2009

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

KR(1)