Urinary Kidney Injury Molecule-1 (KIM-1) Excretion As Biomarker for Injury in Kidney Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00805571
First received: December 5, 2008
Last updated: March 11, 2010
Last verified: March 2010
  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
Kidney Transplant Dysfunction

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Biospecimen Retention:   Samples With DNA

Urine


Estimated Enrollment: 120
Study Start Date: October 2008
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adult
Adult patients with end-stage kidney disease awaiting kidney transplantation.
Pediatric
Children with end-stage kidney disease awaiting kidney transplantation.

Detailed 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.

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805571

Locations
United States, New York
Schneider Children's Hospital
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Beatrice Goilav, MD North Shore-LIJ Health System
  More Information

No publications provided

Responsible Party: Institutional Review Board, North Shore-LIJ Health System
ClinicalTrials.gov Identifier: NCT00805571     History of Changes
Other Study ID Numbers: 08-196
Study First Received: December 5, 2008
Last Updated: March 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Rejection
Infection
Side effect of immunosuppressive drug (nephrotoxicity)

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on August 21, 2014