Introduction: CMV infection has been associated with inferior long-term patient and graft survival. This single center prospective study compares the effect of 3 immunosuppressive regimens on the incidence of CMV infection in KT. Methods: Low immunological risk first KT recipients were randomized to: (G1) single 3 mg/kg dose of antithymocyte globulin, reduced exposure tacrolimus (TAC 4 ng/ml), everolimus (EVR 4-8 ng/mL) and prednisone; (G2) basiliximab, reduced exposure tacrolimus (TAC 6 ng/ml), everolimus (EVR 4-8 ng/mL) and prednisone or (G3) basiliximab, reduced exposure tacrolimus (TAC 8 ng/ml), mycophenolate and prednisone. None of the patients received any CMV prophylaxis. CMV infection is monitored weekly using antigenemia and PCR tests. The primary outcome is the incidence of CMV infection (viremia or disease) during the first year of transplantation. We show preliminary results of the first 170 (G1=45; G2=68; G3=57) out of 300 anticipated patients with mean follow up of 239±104 days. Results: There were no differences in main demographic characteristics including pre-transplant CMV donor/recipient serostatus. The incidence of CMV infection was lower in EVR groups (2 vs. 12 vs. 37%, p=0,000). Furthermore, 17.5% patients in G3 (n=10) developed at least one recurrent event of CMV infection. Nine patients were converted from MPA to EVR and 1 patient still had a further recurrence. Among the high risk donor positive/recipient negative pretransplant CMV serostatus the incidence of CMV infection was 0%, 63% and 100%, respectively.There were no differences in the incidence of biopsy confirmed acute rejection (9 vs. 19 vs. 16%, p= 0.383), overall wound-healing adverse events (18 vs. 28 vs. 23%, p=0.454), respectively. The incidence of delayed graft function was lower in G3 (62.1 vs. 58 vs. 33%, p=0.034) but no differences in mean serum creatinine (1.4±0.5 vs. 1.5±0.4 vs. 1.3±0.4 mg/dL, p= 0.204) and proteinuria (0.3±0.4 vs. 0.4±0.6 vs. 0.2±0.3 mg/dL, p= 0.324) were observed at 6 months. There were 6 deaths (G1=1; G2=3; G3=2) and 5 graft losses (G2=3; G3=2). Conclusions: This preliminary analysis indicates that patients receiving everolimus are at lower risk of developing CMV infection compared to patients receiving MPA with no significant differences in efficacy and other safety parameters.

Tedesco, H.: Grant/Research Support, Everolimus.

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