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Urine Testing to Detect Kidney Transplant Rejection

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ClinicalTrials.gov Identifier: NCT00337220
Recruitment Status : Completed
First Posted : June 15, 2006
Last Update Posted : August 15, 2013
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date June 14, 2006
First Posted Date June 15, 2006
Last Update Posted Date August 15, 2013
Study Start Date June 2006
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Urine Testing to Detect Kidney Transplant Rejection
Official Title Noninvasive Diagnosis of Renal Allograft Rejection by Urinary Cell mRNA Profiling
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and urine collection
Sampling Method Non-Probability Sample
Study Population Patients who have recently undergone kidney transplant
Condition
  • Kidney Transplantation
  • Kidney Disease
  • Kidney Failure, Chronic
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 6, 2013)
492
Original Enrollment
 (submitted: June 14, 2006)
450
Actual Study Completion Date December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00337220
Other Study ID Numbers DAIT CTOT-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators Not Provided
Investigators
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
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date August 2013