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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Allograft Nephropathy

Intervention: prostaglandin I2 analogue (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Jongwon Ha, MD, PhD, Principal Investigator, Affiliation: Seoul National University

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

Clinical Details

Official title: Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: graft pathology, serum creatinine, creatinine clearance, eGFR

Eligibility

Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Seoul National University Hospital, Seoul 110-744, Korea, Republic of
Additional Information

Starting date: June 2009
Last updated: May 24, 2015

Page last updated: August 23, 2015

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