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

NCT00805571 | Completed DMC

• 1 other identifier: 08-196
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplant Dysfunction

Keywords

Rejection; Infection; Side effect of immunosuppressive drug (nephrotoxicity)

Study Arms (2)

Adult

Adult patients with end-stage kidney disease awaiting kidney transplantation.

Pediatric

Children with end-stage kidney disease awaiting kidney transplantation.

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

Sponsors & Collaborators

• Northwell Health: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

Schneider Children's Hospital

New Hyde Park, New York, 11040, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine

MeSH Terms

Conditions

Rejection, Psychology; Infections

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Beatrice Goilav, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 9, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2010
• Last Updated: March 12, 2010

Record last verified: 2010-03

Locations

US (1)