Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy

May 24, 2015 updated by: Jongwon Ha, Seoul National University Hospital
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

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

16 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Drug: prostaglandin I2 analogue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
graft pathology, serum creatinine, creatinine clearance, eGFR
Time Frame: 1 year after drug administration
1 year after drug administration

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jongwon Ha, MD, PhD, Seoul National University

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, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 24, 2010

First Submitted That Met QC Criteria

January 24, 2010

First Posted (Estimate)

January 26, 2010

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 24, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beraprost-01

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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