TruGraf® Long-term Clinical Outcomes Study
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.
- Kidney Transplant Rejection
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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 Type
- Observational Model
- Time Perspective
|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.||
- Transplant Genomics, Inc.
Study ContactIsioma Agboli, MD
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.