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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01056835
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : May 27, 2015
Information provided by (Responsible Party):
Jongwon Ha, 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

Condition or disease Intervention/treatment Phase
Chronic Allograft Nephropathy Drug: prostaglandin I2 analogue Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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

Primary Outcome Measures :
  1. graft pathology, serum creatinine, creatinine clearance, eGFR [ Time Frame: 1 year after drug administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01056835

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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
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Principal Investigator: Jongwon Ha, MD, PhD Seoul National University
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Responsible Party: Jongwon Ha, Professor, Seoul National University Hospital Identifier: NCT01056835    
Other Study ID Numbers: Beraprost-01
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases
Antihypertensive Agents
Platelet Aggregation Inhibitors
Vasodilator Agents