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
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Condition or disease |
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Kidney Transplantation Kidney Disease Kidney Failure, Chronic |
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 |
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 |


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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 |
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

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
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 |
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 |
Publications of Results:
Other Publications:
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 |
allograft graft |
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 |