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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00805571
Study type Observational
Source Northwell Health
Contact
Status Completed
Phase N/A
Start date October 2008