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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01056835
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 60
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Allograft Nephropathy	Drug: prostaglandin I2 analogue	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control	Drug: prostaglandin I2 analogue

Outcome Measures

Primary Outcome Measures

1. graft pathology, serum creatinine, creatinine clearance, eGFR [1 year after drug administration]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Jongwon Ha, MD, PhD, Seoul National University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jongwon Ha, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT01056835
• Other Study ID Numbers: Beraprost-01
• First Posted: Jan 26, 2010
• Last Update Posted: May 27, 2015
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Kidney Diseases; Epoprostenol; Tezosentan

Study Results

No Results Posted as of May 27, 2015