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Urine Testing to Detect Kidney Transplant Rejection

NCT ID: NCT00337220

Last Updated: 2013-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

492 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Kidney Transplantation Kidney Disease Kidney Failure, Chronic

Keywords

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allograft graft

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abraham Shaked, MD, PhD

Role: STUDY_CHAIR

Department of Surgery, University of Pennsylvania Medical Center

John Friedewald, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Stuart Knechtle, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, University of Wisconsin

Jean Emond, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Columbia University

Darshana Dadhania, MD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Cornell University

New York, New York, United States

Site Status

Columbia University

New York, New York, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Dadhania D, Muthukumar T, Ding R, Li B, Hartono C, Serur D, Seshan SV, Sharma VK, Kapur S, Suthanthiran M. Molecular signatures of urinary cells distinguish acute rejection of renal allografts from urinary tract infection. Transplantation. 2003 May 27;75(10):1752-4. doi: 10.1097/01.TP.0000063931.08861.56.

Reference Type BACKGROUND
PMID: 12777869 (View on PubMed)

Ding R, Li B, Muthukumar T, Dadhania D, Medeiros M, Hartono C, Serur D, Seshan SV, Sharma VK, Kapur S, Suthanthiran M. CD103 mRNA levels in urinary cells predict acute rejection of renal allografts. Transplantation. 2003 Apr 27;75(8):1307-12. doi: 10.1097/01.TP.0000064210.92444.B5.

Reference Type BACKGROUND
PMID: 12717221 (View on PubMed)

Li B, Hartono C, Ding R, Sharma VK, Ramaswamy R, Qian B, Serur D, Mouradian J, Schwartz JE, Suthanthiran M. Noninvasive diagnosis of renal-allograft rejection by measurement of messenger RNA for perforin and granzyme B in urine. N Engl J Med. 2001 Mar 29;344(13):947-54. doi: 10.1056/NEJM200103293441301.

Reference Type BACKGROUND
PMID: 11274620 (View on PubMed)

Tatapudi RR, Muthukumar T, Dadhania D, Ding R, Li B, Sharma VK, Lozada-Pastorio E, Seetharamu N, Hartono C, Serur D, Seshan SV, Kapur S, Hancock WW, Suthanthiran M. Noninvasive detection of renal allograft inflammation by measurements of mRNA for IP-10 and CXCR3 in urine. Kidney Int. 2004 Jun;65(6):2390-7. doi: 10.1111/j.1523-1755.2004.00663.x.

Reference Type BACKGROUND
PMID: 15149352 (View on PubMed)

Suthanthiran M, Schwartz JE, Ding R, Abecassis M, Dadhania D, Samstein B, Knechtle SJ, Friedewald J, Becker YT, Sharma VK, Williams NM, Chang CS, Hoang C, Muthukumar T, August P, Keslar KS, Fairchild RL, Hricik DE, Heeger PS, Han L, Liu J, Riggs M, Ikle DN, Bridges ND, Shaked A; Clinical Trials in Organ Transplantation 04 (CTOT-04) Study Investigators. Urinary-cell mRNA profile and acute cellular rejection in kidney allografts. N Engl J Med. 2013 Jul 4;369(1):20-31. doi: 10.1056/NEJMoa1215555.

Reference Type RESULT
PMID: 23822777 (View on PubMed)

Related Links

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http://www.ctotstudies.org

Click here for the Clinical Trials in Organ Transplantation \[CTOT\] public Web site

Other Identifiers

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DAIT CTOT-04

Identifier Type: -

Identifier Source: org_study_id