Incidence of cytomegalovirus infection in seropositive kidney transplant recipients treated with everolimus: A randomized, open‐label, multicenter phase 4 trial

摘要

Cytomegalovirus (CMV) persists as the most frequent opportunistic infection among solid organ transplant recipients. This multicenter trial aimed to test whether treatment with everolimus (EVR) could decrease the incidence of CMV DNAemia and disease. We randomized 186 CMV seropositive kidney transplant recipients in a 1:1 ratio to receive EVR or mycophenolic acid (MPA) in association with basiliximab, cyclosporin, and steroids and 87 in each group were analyzed. No universal prophylaxis was administered to either group. The composite primary endpoint was the presence of CMV DNAemia, CMV treatment, graft loss, death, and discontinuation of the study at 6?months posttransplant. In the modified intent‐to‐treat analysis, 42 (48.3) and 70 (80.5) patients in the EVR and MPA groups reached the primary endpoint (OR?=?0.21, 95 CI: 0.11–0.43, p?