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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Jongwon Ha, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01056835
First received: January 24, 2010
Last updated: July 18, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control Drug: prostaglandin I2 analogue

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056835

Contacts
Contact: Jongwon Ha, MD, PhD +82-2-2072-2991 jwhamd@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Hyejin Hong    +82-2-2072-3550      
Sub-Investigator: Sang Il Min, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jongwon Ha, MD, PhD Seoul National University
  More Information

No publications provided

Responsible Party: Jongwon Ha, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01056835     History of Changes
Other Study ID Numbers: Beraprost-01
Study First Received: January 24, 2010
Last Updated: July 18, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Tezosentan
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014