*Purpose: TAC and MPA combination is considered the standard of care immunosuppressive regimen in the majority of transplant centers worldwide. Yet, given the lack of novel drug combinations, the use of mTOR inhibitors remains as the only available option with comparable efficacy but distinct safety profile.

*Methods: This large, single center, prospective randomized trial compares the efficacy, safety, therapeutic drug monitoring and an array of candidate biomarkers of the use of SRL (3 mg QD adjusted to maintain concentrations between 4 to 8 ng/mL), EVR (3 mg BID adjusted to maintain concentrations between 4 to 8ng/mL), or MPA (720 mg BID) in kidney transplant recipients receiving 3 mg/kg r-ATG induction therapy, tacrolimus and faster prednisone taper (Clinicaltrials.govNCT03468478).

*Results: This preliminary analysis includes data from the first 153 kidney transplants recipients receiving SRL (n=51), EVR (n=50), or MPA (n=52). Mean transplant follow up time is 234±139 days. Key efficacy and safety outcomes are shown in Table. While the incidence of CMV infection/disease is higher in the MPA group, there is no similar trend for BKV infection despite higher mean viral load and one patient with polyomavirus nephropathy. There is no difference in the incidence of biopsy proven acute rejection (BPAR) and treatment discontinuation rate. There is also no difference in estimated glomerular filtration rate (eGFR) trajectories from month 1 to 3 months.

*Conclusions: These preliminary data suggest that comparable mTOR inhibitor exposures show similar efficacy compared to MPA and lower incidence of viral infection.

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