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Urine Testing to Detect Kidney Transplant Rejection

This study has been completed.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID) Identifier:
First received: June 14, 2006
Last updated: August 13, 2013
Last verified: August 2013
The purpose of this study is to determine if analysis of urine samples for specific markers can predict transplant rejection in people who have received kidney transplants.

Kidney Transplantation
Kidney Disease
Kidney Failure, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Diagnosis of Renal Allograft Rejection by Urinary Cell mRNA Profiling

Resource links provided by NLM:

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Biospecimen Retention:   Samples With DNA
Blood and urine collection

Enrollment: 492
Study Start Date: June 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Innovations in kidney transplantation have improved short-term outcomes for transplant patients. However, organ rejection remains as an important threat to the long-term survival of the transplanted organ. An increase in the serum creatinine level is often the first clinical indicator of kidney transplant rejection; however, this marker lacks sensitivity and specificity. Rejection is currently diagnosed using an invasive transplant biopsy procedure; in addition to being expensive, transplant biopsies can result in bleeding from the transplant and even graft loss. In early studies, it has been observed that significant increases in the levels of perforin, granzyme B, and CD3 messenger RNA (mRNA) in urinary cells signal the development of acute transplant rejection. The purpose of this study is to evaluate whether the noninvasive procedure of measuring perforin, granzyme B, and CD3 mRNA levels in urine samples can accurately diagnose and predict kidney transplant rejection, make transplant biopsy unnecessary, and provide an opportunity to initiate treatment for early rejection with the aim to minimize damage to the kidney.

This study will last 3 years post-transplant. There will be a total of 14 study visits. Blood and urine collection will occur at all visits. Additional visits may be necessary for those participants who develop abnormal kidney function.


Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have recently undergone kidney transplant

Inclusion Criteria:

  • Scheduled to undergo primary or redo deceased- or living-donor kidney transplantation
  • Ability to provide informed consent

Exclusion Criteria:

  • Requires combined organ transplantation
  • Previously received a solid organ transplant (other than kidney transplant) or islet cell transplant
  • HCV infected
  • HIV infected
  Contacts and Locations
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Please refer to this study by its identifier: NCT00337220

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, New York
Cornell University
New York, New York, United States, 10021
Columbia University
New York, New York, United States, 10032
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Abraham Shaked, MD, PhD Department of Surgery, University of Pennsylvania Medical Center
Principal Investigator: John Friedewald, MD Northwestern University
Principal Investigator: Stuart Knechtle, MD Department of Surgery, University of Wisconsin
Principal Investigator: Jean Emond, MD Department of Surgery, Columbia University
Principal Investigator: Darshana Dadhania, MD Cornell University
  More Information

Additional Information:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00337220     History of Changes
Other Study ID Numbers: DAIT CTOT-04
Study First Received: June 14, 2006
Last Updated: August 13, 2013

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic processed this record on May 25, 2017