Urinary Kidney Injury Molecule-1 (KIM-1) Excretion As Biomarker for Injury in Kidney Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT00805571|
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : March 12, 2010
|Condition or disease|
|Kidney Transplant Dysfunction|
- To investigate the role of urinary Kim-1 excretion as a marker of delayed graft function, acute kidney allograft rejection and/or virus-induced allograft nephropathy and/or calcineurin-inhibitor nephrotoxicity.
- To determine the role of urinary Kim-1 excretion in predicting long term outcome after kidney transplantation compared to standard diagnostic tests.
- To determine the role of reduction in urinary Kim-1 excretion after a rejection episode and/or viral infection as a marker of repair of renal tubules.
Monitoring of urinary KIM-1 in kidney transplant recipients will facilitate the detection of delayed graft function, acute allograft rejection or infectious causes of proximal tubular injury, allowing earlier intervention with better long-term graft survival. Detection of urinary KIM-1 will precede increases in serum creatinine to detect acute graft injury and urinary KIM-1 will decrease faster than serum creatinine and will predict responsiveness (or lack thereof) to intervention more accurately.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Urinary Kidney Injury Molecule-1 As Diagnostic Biomarker of Proximal Tubular Injury in Adult and Pediatric Transplant Recipients|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||February 2010|
Adult patients with end-stage kidney disease awaiting kidney transplantation.
Children with end-stage kidney disease awaiting kidney transplantation.
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): NCT00805571
|United States, New York|
|Schneider Children's Hospital|
|New Hyde Park, New York, United States, 11040|
|Principal Investigator:||Beatrice Goilav, MD||Northwell Health|