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| Sponsors and Collaborators: |
North Shore Long Island Jewish Health System Astellas Pharma US, Inc. |
|---|---|
| Information provided by: | North Shore Long Island Jewish Health System |
| ClinicalTrials.gov Identifier: | NCT00805571 |
Purpose
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.
| Condition |
|---|
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Kidney Transplant Dysfunction |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Urinary Kidney Injury Molecule-1 As Diagnostic Biomarker of Proximal Tubular Injury in Adult and Pediatric Transplant Recipients |
Urine
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2008 |
| Groups/Cohorts |
|---|
|
Adult
Adult patients with end-stage kidney disease awaiting kidney transplantation.
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Pediatric
Children with end-stage kidney disease awaiting kidney transplantation.
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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.
Eligibility| Ages Eligible for Study: | 3 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Contacts and Locations| Contact: Beatrice Goilav, MD | 718-470-3491 | bgoilav@nshs.edu |
| Contact: Howard Trachtman, MD | 718-470-3491 | trachtma@lij.edu |
| United States, New York | |
| Schneider Children's Hospital | Recruiting |
| New Hyde Park, New York, United States, 11040 | |
| Contact: Jonathan Bromberg, MD, PhD 212-659-8086 jon.bromberg@mountsinai.org | |
| Principal Investigator: Batrice Goilav, MD | |
| Principal Investigator: | Beatrice Goilav, MD | North Shore-LIJ Health System |
More Information
| Responsible Party: | North Shore-LIJ Health System ( Institutional Review Board ) |
| Study ID Numbers: | 08-196 |
| Study First Received: | December 5, 2008 |
| Last Updated: | December 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00805571 |
| Health Authority: | United States: Institutional Review Board |
|
Rejection Infection Side effect of immunosuppressive drug (nephrotoxicity) |
