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

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Chronic Allograft Nephropathy

Treatments: Drug: prostaglandin I2 analogue

Study type: Interventional

Funder types: Other

Identifiers

NCT01056835

Beraprost-01

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 1 patient group

control

No Intervention group

Treatment:

Drug: prostaglandin I2 analogue