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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | TruGraf® Long-term Clinical Outcomes Study
