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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01056835
First Posted: January 26, 2010
Last Update Posted: May 27, 2015
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.
Information provided by (Responsible Party):
Jongwon Ha, Seoul National University Hospital
  Purpose
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 Intervention Phase
Chronic Allograft Nephropathy Drug: prostaglandin I2 analogue Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jongwon Ha, Seoul National University Hospital:

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

Estimated Enrollment: 40
Study Start Date: June 2009
Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control Drug: prostaglandin I2 analogue

  Eligibility

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01056835


Locations
Korea, Republic of
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
  More Information

Responsible Party: Jongwon Ha, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01056835     History of Changes
Other Study ID Numbers: Beraprost-01
First Submitted: January 24, 2010
First Posted: January 26, 2010
Last Update Posted: May 27, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Epoprostenol
Tezosentan
Antihypertensive Agents
Platelet Aggregation Inhibitors
Vasodilator Agents