Introduction: CMV infection is a frequent complication following organ transplantation, and is associated with inferior long-term patient and graft survival. Here we report the results from a 1-year, prospective, single centre, open-label study designed to compare the effects of 2 immunosuppressive regimens on the incidence of CMV infection in renal transplant recipients (RTxR).

Methods: 120 low immunological risk (PRA <50%) de novo RTxR were randomized (1:1) within 24h post-transplantation to either one of the two reduced tacrolimus (Tac) exposure regimens: (G1) everolimus (EVR, 1.5 mg bid, C0 3–8ng/mL) with very low dose Tac or (G2) sodium mycophenolate (MPA) with low dose Tac. All patients received Thymoglobulin (6mg/kg/day) ± steroids. For the first 3 months (M) all patients received Tac (0.1 mg/kg/day, C0 4–7 ng/mL). After that, G1 Tac was targeted to C0 2–4ng/mL whereas G2 continued the initial regimen unchanged. The primary outcome in this study was the incidence of CMV infection or disease during the first year of transplantation. None of the patients received CMV prophylaxis. CMV infection was monitored fortnightly using a commercial quantitative CMV PCR assay (DNAemia expressed in IU /mL) for the first 3 M, then monthly until M6.

Results: Intention to treat population of 120 RTxR (G1=60; G2=60) showed comparable baseline characteristics, with a mean age of 43.5±14 (18-76) years with 77 % male and 97% recipients from deceased donor (DD). Mean donor age was 32.5±13 (9-62) years and for DD transplants, the mean cold ischemia time was 24 ± 9 (9.5-58) hours. CMV serum status D⁺/ R^– was observed in 7 patients in G1 and 3 patients in G2. CMV infection occurred in 9 (15%) patients in G1, 8 asymptomatic DNAemia and 1 syndrome, versus 31 (52%) in G2, 27 asymptomatic DNAemia and 4 syndrome (p<0.001). There was no case of invasive CMV disease. Overall graft survival was 98%, with 1 graft loss in each group. Biopsy proven acute rejection was seen in 6 (5%), 4 (6.6%) in G1 and 2 (3.3%) in G2. Conclusions: Two-Year analysis indicates that patients receiving everolimus are at lower risk to develop CMV infection [RR=0.29 (95% CI: 0.152 a 0.556); p <0.001]. These regimens also appear to provide comparable efficacy for the prevention of acute rejection and similar renal function.

CITATION INFORMATION: Esmeraldo R, Oliveira M, Pinheiro P, Girao C, Freitas T. Prospective Randomized OPEN Trial Designed to Reduce the Incidence of Cytomegalovirus (CMV) Infection in DE NOVO Kidney Transplant Recipients Two-Year Results. Am J Transplant. 2016;16 (suppl 3).

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