Recruiting

TruGraf®TruGraf® Long-term Clinical Outcomes Study

Sponsor:

Transplant Genomics, Inc.

Code:

NCT04491552

Conditions

Kidney Transplant Rejection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patients monitored with TruGraf and TRAC testing

Study Details

Brief 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.

Conditions

Kidney Transplant Rejection

Study ID

NCT04491552

Start date

Sep 9, 2020

Status verified date

Nov, 2022

Completion date

Nov, 2023

Anticipated

Primary completion date

Sep, 2023

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 of post-transplant care; and

Exclusion Criteria:

Recipient of a combined organ transplant with an extra-renal organ and/or islet cell transplant;
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

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients monitored with TruGraf and TRAC testing

Subjects will have TruGraf and TRAC testing at study enrollment (Baseline) and thereafter every 3 months. In addition subjects will have TRAC testing at any time there is a suspicion of acute rejection.

Interventions

Patients monitored with TruGraf and TRAC testing

This is an observational study there are no protocol mandated interventions. TruGraf and TRAC results will be utilized in conjunction with standard of care assessments to determine patient management.

Primary outcome measure

occurrence of either biopsy proven acute rejection (BPAR) on a for cause biopsy or graft loss, or a decrease from baseline in eGFR > 10 mL/min. [ Time Frame: Baseline to month 24 ]

Central Contacts and Locations

Central contacts

Isioma Agboli, MD

510-767-8609 isiomaagboli@eurofins-tgi.com

Locations

Banner University Medical Center Tucson

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Primary Coordinator

stephm1@arizona.edu

Fresno Nephrology Medical Group

Recruiting

Fresno, California, United States, 93720

Contacts

Primary Coordinator

ngill@themedicalresearchgroup.com

Scripps Memorial Hospital La Jolla

Recruiting

La Jolla, California, United States, 92037

Contacts

Primary Coordinator

barrick.bethany@scrippshealth.org

Keck Hospital of USC

Recruiting

Los Angeles, California, United States, 90033

Contacts

Primary Coordinator

esther.park@med.usc.edu

House of Transplant and Cancer- Riverside Community Hospital

Recruiting

Riverside, California, United States, 92501

Contacts

Primary Coordinator

payam.javaherizadeh@hcahealthcare.com

University of California Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Primary Coordinator

khowes@ucdavis.edu

California Pacific Medical Center

Recruiting

San Francisco, California, United States, 94109

Contacts

Primary Coordinator

razavirf@sutterhealth.org

MedStar Georgetown University Hospital

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

Primary Coordinator

ALYSSA.STUCKE@georgetown.edu

Northwestern University

Recruiting

Chicago, Illinois, United States, 60208

Contacts

Study Coordinator

a-daud@northwestern.edu

University of Illinois-Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Primary Coordinator

kbruno@uic.edu

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Primary Coordinator

edelaney2@kumc.edu

Tulane University Hospital and Clinic

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Primary Coordinator

dbartho@tulane.edu

Willis-Knighton Medical Center

Recruiting

Shreveport, Louisiana, United States, 71103

Contacts

Primary Coordinator

sstephens2@wkhs.com

Universtiy of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Primary Coordinator

maheen.khan@som.umaryland.edu

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Primary Coordinator

ADUROCHER2@mgh.harvard.edu

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Primary Coordinator

smcderm2@bidmc.harvard.edu

Renal and Transplant Associates of New England

Recruiting

Springfield, Massachusetts, United States, 01107

Contacts

Primary Coordinator

JWhitbeck@rtane.org

Primary Coordinator Coordinator

Recruiting

Saint Louis, Missouri, United States, 63110

Contacts

Primary Coordinator Coordinator

devinwall@wustl.edu

Primary Coordinator

aomar@wustl.edu

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Primary Coordinator

katie.ostlund@unmc.edu

University of New Mexico Health Sciences Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Primary Coordinator

dlsedillo@salud.unm.edu

Montefiore Medical Center

Recruiting

Bronx, New York, United States, 10467

Contacts

Primary Coordinator

OMOHAMME@montefiore.org

Erie County Medical Center

Recruiting

Buffalo, New York, United States, 14215

Contacts

Primary Coordinator

msacilowsk@ecmc.edu

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14618

Contacts

Study Coordinator

Allison_Stewart@URMC.Rochester.edu

UR Medicine Strong Memorial Hospital

Recruiting

Rochester, New York, United States, 14642

Contacts

Primary Coordinator

allison_stewart@urmc.rochester.edu

Vidant Medical Center

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Study Coordinator

apontet21@ecu.edu

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Primary Coordinator

grimml@ccf.org

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Primary Coordinator

jarrod.goodarz@pennmedicine.upenn.edu

Temple University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Primary Coordinator

sally.quinn@tuhs.temple.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Primary Coordinator

saundert@musc.edu

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Primary Coordinator

Morgan.Marsh@UTSouthwestern.edu

Clinical Research Strategies

Recruiting

Houston, Texas, United States, 77030

Contacts

Primary Coordinator

sonny@kidneydocs.org

Utah Kidney Research Institute

Recruiting

Salt Lake City, Utah, United States, 84115

Contacts

Clinical Research Manager

ukrinephrology@gmail.com

University of Utah Hospital

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Primary Coordinator

Amber.lamph@hsc.utah.edu

Inova Fairfax Hospital

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Study Coordinator

lori.schlegel@inova.org

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Primary Coordinator

joyce.ruddley@vcuhealth.org

Primary Coordinator

Recruiting

Seattle, Washington, United States, 98195

Contacts

Primary Coordinator

nidhim3@Nephrology.washington.edu

More Information

Sponsor

Transplant Genomics, Inc.

Last update posted

Nov 14, 2022

Last verified

Nov, 2022

Keywords

Biomarkers
Subclinical Rejection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Transplant Genomics, Inc. on 2022-11-14.