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.



Eligible Ages
Over 18 Years
Eligible Genders
Accepts Healthy Volunteers

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

Study Type
Observational Model
Time Perspective

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Diagnostic Test: 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.

Recruiting Locations

Tulane University Hospital and Clinic
New Orleans, Louisiana 70112
Primary Coordinator

More Details

Transplant Genomics, Inc.

Study Contact

Isioma Agboli, MD

Detailed 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.


Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.