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Completed

NCT Number: NCT01056835

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

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

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Key information

Conditions

Chronic Allograft Nephropathy

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prostaglandin I2 analogue

Drug

Primary outcomes

  1. graft pathology, serum creatinine, creatinine clearance, eGFR

    Time frame: 1 year after drug administration

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Jan 26, 2010
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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