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

Phase 3

Completed

• Conditions: Chronic Allograft Nephropathy
• Interventions: Drug: prostaglandin I2 analogue

• Registration Number: NCT01056835
• Lead Sponsor: Seoul National University Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-01-24
• Study First Submitted QC: 2010-01-24
• Study First Posted: 2010-01-26
• Primary Completion: 2013-12
• Study Completion: 2014-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-24
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	prostaglandin I2 analogue	-

Primary Outcome Measures

Name	Time	Method
graft pathology, serum creatinine, creatinine clearance, eGFR	1 year after drug administration

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of