TruGraf® Long-term Clinical Outcomes Study

Transplant Genomics, Inc.2,000 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Kidney Transplant Rejection

Interventions

Patients monitored with TruGraf and TRAC testingDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (36)

Outcomes

Primary Outcomes

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.