Immunosuppression Minimization In Kidney Transplant Recipients with Transplant Excellence Based on the TruGraf Test

Background: We prospectively evaluated the utility of serial TruGraf testing to guide immunosuppression (IS) management following Kidney Transplant (KT). Methods: Pts undergoing KT and meeting inclusion (primary txp; cPRA <50; no DSA; non-African American recipients) and exclusion (multi-organ and HLA-identical living related recipients) criteria are consented at the time of KT. Pts who consent enter Part I of the study, receive Thymo induction (>3 mg/kg), have steroids withdrawn at 30 d post-txp, and maintained on MMF and Tacro IS. Pts are followed with weekly labs. Pts qualifying for Part II of the study (eGFR >45 mL/min; BK viremia <10,000 copies/mL; no acute rejection episodes) are randomized 2:1 to study group : standard of care at 3mos post-txp. All pts also receive serial TruGraf testing monthly for mos 3-9, and at 12 mos post-txp. Study group receive TruGraf results in real time and used to guide IS reduction. If result is Transplant eXcellence (TX), first step in IS minimization is to decrease MMF dose followed by decrease in Tac target trough to between 3 & 6 ng/mL. Control group are managed per center standard of care & TruGraf samples will be analyzed at end of the study . Results: Enrollment is completed and IS minimization is ongoing. 82 pts were enrolled. 73 pts completed 3 mos posttxp follow-up & qualified to be randomized into Part II of the study (52 to study arm and 21 to control arm); 57 pts completed the study; 40 pts in the study arm and 17 in the control arm. Renal function and IS results are shown in the Table below. To date, DSA was checked in 30 pts who completed the study. 25/30 (83.3%) had no DSA; 3/30 (10%) had de novo Class I DSA; and 2/30 (6.7%) had de novo Class II DSA. One study arm pt with elevated serum creat level and TruGraf TX had borderline acute rejection on biopsy (1/52 or 2%). Conclusion: Results of this study are anticipated to provide helpful information necessary for IS minimization and have the potential to individualize pt care and improve outcomes by reducing infections and malignancies while maintaining good graft function. Funding: Commercial Support - Transplant Genomics Results 12 m - Study (N=40) Control (N=17) eGFR 73.70 75.64 S. Creatinine (mg/dL) 1.20 1.23 Tacro level (ng/mL) 6.88 7.26 MMF dose (mg/day) 1054 1719