Chronic Allograft Nephropathy Clinical Trial
Official title:
Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy
Verified date | May 2015 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
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
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 50 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | graft pathology, serum creatinine, creatinine clearance, eGFR | 1 year after drug administration |
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