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Urine Testing to Detect Kidney Transplant Rejection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00337220
First received: June 14, 2006
Last updated: August 13, 2013
Last verified: August 2013

June 14, 2006
August 13, 2013
June 2006
December 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00337220 on ClinicalTrials.gov Archive Site
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Urine Testing to Detect Kidney Transplant Rejection
Noninvasive Diagnosis of Renal Allograft Rejection by Urinary Cell mRNA Profiling

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood and urine collection

Non-Probability Sample

Patients who have recently undergone kidney transplant

  • Kidney Transplantation
  • Kidney Disease
  • Kidney Failure, Chronic
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
492
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
up to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00337220
DAIT CTOT-04
Yes
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
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
National Institute of Allergy and Infectious Diseases (NIAID)
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP