Urinary Kidney Injury Molecule-1 (KIM-1) Excretion As Biomarker for Injury in Kidney Transplant Recipients
The purpose of this study is to determine if measuring the level of a protein called Kidney Injury Molecule-1 (KIM-1) in the urine will help healthcare providers detect any problems with the transplanted kidney before the laboratory investigations that are used on a routine basis do. This approach may allow the doctor to intervene at an earlier point of a rejection episode and may thereby prolong survival of the transplant kidney.
Kidney Transplant Dysfunction
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Adult patients with end-stage kidney disease awaiting kidney transplantation.
Children with end-stage kidney disease awaiting kidney transplantation.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805571
|United States, New York|
|Schneider Children's Hospital|
|New Hyde Park, New York, United States, 11040|
|Principal Investigator:||Beatrice Goilav, MD||North Shore-LIJ Health System|