Introduction: There is no standard of care immunosuppressive regimen for recipients of kidneys recovered from expanded criteria donors. Several centers use r-ATG induction due to the higher risk of delayed graft function and acute rejection, increasing the risk of CMV infection.

Objectives: This study compares the efficacy and safety of EVR or MPS in ECD kidney transplant recipients. Methods: This is a prospective, randomized, single center study designed to enroll 200 patients (1:1) to receive r-ATG induction (4 doses of 1.5 mg/kg every other day), prednisone, EVR or MPS and delayed introduction of TAC (day 7) to maintaim trough blood concentrations around 5 ng/ml. This preliminary analysis was performed with 127 randomized patients (EVR n=68 and MPS n=59) who completed 6 months of follow up. Preemptive strategy using pp65 antigenemia test was use to manage CMV infection. Results: There were no differences in mean kidney donor profile index (KDPI, 89±9 vs. 89±8%) and mean kidney donor risk index (KDRI, 1.7±0.4 vs. 1.7±0.3) comparing EVR and MPS groups, respectively. There were no differences in main demographic characteristics except for the incidence of diabetes mellitus (EVR, 38% vs. MPS, 15%). There was no difference in incidence of delayed graft function (54 vs. 64%, p=0.253) but duration was lower in MPS group (11.1 ±11.9 vs. 5.0±4.6 days, p= 0.004). The incidence of first CMV infection was lower in EVR group (12 vs. 76%, p=0,000). Furthermore, 36% of patients in MPS (n=21) developed at least one recurrent event of CMV infection. Higher incidence of treated acute rejection (36 vs. 23%, p=0.165) or treated biopsy confirmed acute rejection (18 vs. 10%, p=0.197) was observed in the EVR group. At 6 months mean estimated glomerular filtration rate was higher in the MPS group (MRDR, 38.1±16.2 vs. 48.1±14.8 mL/min, p=0.003). Treatment discontinuation was higher in the MPS group (18% vs. 32%), primarily due to recurrent CMV infections. Conclusions: This preliminary analysis indicates that patients receiving EVR show lower incidence of CMV infection but higher incidence of acute rejection and lower renal function compared to patients receiving MPS.

CITATION INFORMATION: Tedesco-Silva H, Felipe C, Brigido A, Bessa A, Paula M, Ruppel P, Cristelli M, Viana L, Basso G, Franco M, Aguiar W, Medina-Pestana J. Everolimus (EVR) versus Mycophenolate Sodium (MPS) for Recipients of Kidney Transplants from Expanded Criteria Donors (ECD) Receiving Anti-Thymocyte Globulin (r-ATG) and Tacrolimus (TAC). Am J Transplant. 2016;16 (suppl 3).

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