TruGraf® Long-term Clinical Outcomes Study

Last updated: November 10, 2022
Sponsor: Transplant Genomics, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04491552
TGRP06
  • Ages > 18
  • All Genders

Study Summary

This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent and HIPAA authorization;
  • At least 18 years of age;
  • Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant;
  • At least 3-months post-transplant;
  • Stable serum creatinine (per Principal Investigator);
  • Treated with any immunosuppressive regimen, and;
  • Selected by provider to undergo OmniGraf™ (TruGraf® and TRAC™) testing as part ofpost-transplant care; and

Exclusion

Exclusion Criteria:

  • Recipient of a combined organ transplant with an extra-renal organ and/or islet celltransplant;
  • Recipient of a previous non-renal solid organ and/or islet cell transplant;
  • Known to be pregnant;
  • Known to be infected with HIV;
  • Known to have Active BK nephropathy;
  • Known to have nephrotic proteinuria (Per Principal Investigator);
  • Participation in other biomarker studies testing clinical utility.

Study Design

Total Participants: 2000
Study Start date:
September 09, 2020
Estimated Completion Date:
November 30, 2023

Study Description

Several studies have validated TruGraf® in stable renal transplant patients to rule out subclinical acute rejection. These studies generally evaluated the diagnostic value of TruGraf® at single timepoints. Thus the value of serial monitoring and changes over time has not been previously investigated. In addition, no study has assessed TruGraf® and TRAC™in a serial and longitudinal fashion.

Therefore the aim of this study is to evaluate the impact of serial monitoring renal transplant patients with both TruGraf® and TRAC™ on long term outcomes.

Connect with a study center

  • Banner University Medical Center Tucson

    Tucson, Arizona 85724
    United States

    Active - Recruiting

  • Fresno Nephrology Medical Group

    Fresno, California 93720
    United States

    Active - Recruiting

  • Scripps Memorial Hospital La Jolla

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Keck Hospital of USC

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • House of Transplant and Cancer- Riverside Community Hospital

    Riverside, California 92501
    United States

    Active - Recruiting

  • University of California Davis

    Sacramento, California 95817
    United States

    Active - Recruiting

  • California Pacific Medical Center

    San Francisco, California 94109
    United States

    Active - Recruiting

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60208
    United States

    Active - Recruiting

  • University of Illinois-Chicago Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Tulane University Hospital and Clinic

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • Willis-Knighton Medical Center

    Shreveport, Louisiana 71103
    United States

    Active - Recruiting

  • Universtiy of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Renal and Transplant Associates of New England

    Springfield, Massachusetts 01107
    United States

    Active - Recruiting

  • Primary Coordinator Coordinator

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico 87106
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Active - Recruiting

  • Erie County Medical Center

    Buffalo, New York 14215
    United States

    Active - Recruiting

  • UR Medicine Strong Memorial Hospital

    Rochester, New York 14642
    United States

    Active - Recruiting

  • University of Rochester Medical Center

    Rochester, New York 14618
    United States

    Active - Recruiting

  • Vidant Medical Center

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Clinical Research Strategies

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Utah Hospital

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

  • Utah Kidney Research Institute

    Salt Lake City, Utah 84115
    United States

    Active - Recruiting

  • Inova Fairfax Hospital

    Falls Church, Virginia 22042
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Primary Coordinator

    Seattle, Washington 98195
    United States

    Active - Recruiting

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