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Urine Testing to Detect Kidney Transplant Rejection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00337220
Recruitment Status : Completed
First Posted : June 15, 2006
Last Update Posted : August 15, 2013
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease
Kidney Transplantation Kidney Disease Kidney Failure, Chronic

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.

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Study Type : Observational
Actual Enrollment : 492 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Diagnosis of Renal Allograft Rejection by Urinary Cell mRNA Profiling
Study Start Date : June 2006
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Biospecimen Retention:   Samples With DNA
Blood and urine collection

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337220

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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)
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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
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00337220    
Other Study ID Numbers: DAIT CTOT-04
First Posted: June 15, 2006    Key Record Dates
Last Update Posted: August 15, 2013
Last Verified: August 2013
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Renal Insufficiency, Chronic
Chronic Disease
Disease Attributes
Pathologic Processes