BACKGROUND: CMV infection is associated with inferior long-term kidney transplant outcomes. This study compared the incidence of CMV infection/disease in de novo kidney transplant recipients receiving three immunosuppressive regimens and no CMV pharmacological prophylaxis.

METHODS: We randomized and treated (1:1:1) 288 low/moderate kidney transplant recipients to receive a single 3 mg/kg dose of rabbit antithymocyte globulin, tacrolimus, everolimus and prednisone (r-ATG/EVR, n=85), basiliximab, tacrolimus, everolimus and prednisone (BAS/EVR, n=102) or basiliximab, tacrolimus, mycophenolate and prednisone (BAS/MPS, n=101). The primary end-point was the cumulative incidence of first CMV infection/disease in the intention to treat population. Secondary end-points included biopsy confirmed acute rejection, graft loss, death, renal function and safety.

RESULTS: Patients receiving EVR showed lower incidence of CMV infection/disease compared to those receiving MPS (4.7 vs. 10.8 vs. 37.6%, p<0.001). There were no differences in the incidence of first treated biopsy confirmed acute rejection (9.4 vs. 18.6 vs. 15.8%, p=0.403), patient (96.5 vs. 95.1 vs. 96%, p=0.893) and graft (95.3 vs. 93.1 vs. 89.1%, p=0.267) survivals. There were no differences in the incidence of wound-healing complications (23.5 vs. 34.3 vs. 22.8%, p=0.123) and delayed graft function (47 vs. 48.5 vs. 41.5%, p=0.701). Mean estimated glomerular filtration rate was lower in BAS/EVR (65.7±21.8 vs. 60.6±20.9 vs. 69.5±21.5 ml/min, p=0.021) respectively, but no differences in proteinuria was observed.

CONCLUSION: In de novo kidney transplant recipients receiving TAC-based immunosuppressive regimen and no pharmacological CMV prophylaxis, the use of everolimus was associated with a significant reduction in the incidence of CMV infection/disease compared to mycophenolate.

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