Kidney Transplant Dysfunction Clinical Trial
Official title:
Urinary Kidney Injury Molecule-1 As Diagnostic Biomarker of Proximal Tubular Injury in Adult and Pediatric 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.
SPECIFIC AIMS:
1. 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.
2. To determine the role of urinary Kim-1 excretion in predicting long term outcome after
kidney transplantation compared to standard diagnostic tests.
3. 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.
HYPOTHESIS:
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.
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Observational Model: Cohort, Time Perspective: Prospective