Purpose

This is a prospective, multi-center, observational study. Subjects will have TruGraf® and TRAC™ testing at study enrollment and thereafter every 3 months. In addition subjects will have 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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 1-year post-transplant (+/- 2 months); - Stable serum creatinine (current serum creatinine < 2.3 mg/dl, < 20% increase compared to the average of the previous 3 serum creatinine levels); - Treated with any immunosuppressive regimen, and; - Selected by provider to undergo TruGraf® and TRAC™ testing as part of post-transplant care; and - Has Medicare Part B coverage.

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 BK nephropathy; - Known to have nephrotic proteinuria (urine protein > 3 gm/day).

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

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

Universtiy of Maryland Medical Center
Baltimore, Maryland 21201
Contact:
Primary Coordinator
maheen.khan@som.umaryland.edu

More Details

Status
Recruiting
Sponsor
Transplant Genomics, Inc.

Study Contact

Isioma Agboli, MD
510-767-8609
isiomaagboli@eurofins-tgi.com

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.

Notice

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.