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

NCT ID: NCT01056835

Last Updated: 2015-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2014-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Chronic Allograft Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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control

Group Type NO_INTERVENTION

prostaglandin I2 analogue

Intervention Type DRUG

Interventions

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prostaglandin I2 analogue

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jongwon Ha

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jongwon Ha, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Beraprost-01

Identifier Type: -

Identifier Source: org_study_id

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