An observational study in Kidney Transplant Dysfunction, sponsored by Northwell Health. Completed at 1 site in United States. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2010-03-12.
Sponsored by Northwell Health · Observational
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:
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.
56 studies on the registry are indexed under Rejection, Psychology; 29 are open to participants now.
This study's planned enrollment of 120 is below the median of 184 across 27 observational studies indexed under Rejection, Psychology.
Browse Rejection, Psychology studies →Northwell Health is the lead sponsor of 473 studies on the registry; 106 are open to participants now.
Of its 43 completed or terminated interventional studies of FDA-regulated products, 22 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult and pediatric patients with chronic renal failure who are listed at Mount Sinai Hospital for a deceased donor kidney transplant and/or who are in the process of having a living donor evaluation are eligible to participate. One urine sample will be sent for KIM-1 measurement before transplantation, once the patient or the caregiver of the patient consents to participation in the study. The next specimen of urine will only be collected status post kidney transplant in the immediate post-operative phase and on routine visits thereafter. The study does not require obtaining any extra blood or urine specimens, but uses urine that would otherwise be discarded.
Inclusion Criteria:
Children and adults from the age of 3 years who are eligible transplant candidates listed for deceased donor kidney or who are scheduled for a living related or unrelated donor kidney transplant at Mount Sinai Hospital will be eligible for inclusion in this project. Patients will be recruited from the population awaiting kidney transplant treated at the Schneider Children's Hospital and Mount Sinai Hospital.
Adult patients with end-stage kidney disease awaiting kidney transplantation.
Children with end-stage kidney disease awaiting kidney transplantation.
The record gives a start of Oct 2008 and a primary completion of Feb 2010. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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