Back to resultsEffects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy
Primary Purpose
Chronic Allograft Nephropathy
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
prostaglandin I2 analogue
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Allograft Nephropathy
Eligibility 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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
control
Arm Description
Outcomes
Primary Outcome Measures
graft pathology, serum creatinine, creatinine clearance, eGFR
Secondary Outcome Measures
Full Information
NCT ID
NCT01056835
First Posted
January 24, 2010
Last Updated
May 24, 2015
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01056835
Brief Title
Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy
Official Title
Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Allograft Nephropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
prostaglandin I2 analogue
Primary Outcome Measure Information:
Title
graft pathology, serum creatinine, creatinine clearance, eGFR
Time Frame
1 year after drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jongwon Ha, MD, PhD
Organizational Affiliation
Seoul National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy
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