Reduced Incidence of Cytomegalovirus Infection in Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses.
Tedesco-Silva H, Felipe C, et al.American Journal of Transplantation 2015 Oct;15(10):2655-64.
Aims
To compare the incidence of CMV infection/disease in de novo kidney transplant recipients receiving tacrolimus (TAC)-based immunosuppressive regimens combined with everolimus (EVR) or mycophenolate sodium (MPS).
Interventions
Eligible patients were randomized to one of three immunosuppressive regimes. Group 1 received a single 3mg/kg dose of antithymocyte globulin, tacrolimus, everolimus, and prednisone. Group 2 received basiliximab, tacrolimus, everolimus, and prednisone, and Group 3 received basiliximab, tacrolimus, mycophenolate, and prednisone.
Participants
288 low to moderate immunological risk adult recipients of their first ABO-compatible renal transplants from living or deceased donors
Outcomes
The primary outcome was the cumulative incidence of CMV infection/disease during the first year after transplantation. Secondary outcomes included treatment failure, acute rejection, incidence and duration of DGF, renal and spot urine protein/creatinine ratio, incidence of adverse events, malignancies, and laboratorial abnormalities.
Follow-up
12 months
CET Conclusions
This is a well conducted and reported study that was adequately randomised and was analysed by intention-to-treat. It is made a little difficult to interpret due to the fact that there were three arms assessed. A Basiliximab/Everolimus/reduced-dose-Tacrolimus regimen resulted in less CMV infection or disease than a Basiliximab/Mycophenolate/Tacrolimus regimen. Even less CMV infection or disease was seen with ATG/Everolimus/reduced-dose-Tacrolimus regimen. The trial was conducted in patients receiving no CMV prophylaxis however. Also, and most importantly, there were very few patients in the high risk category of donor positive to recipient negative. In order to counter claims of confounding variables in these complex regimens, the authors conducted a multivariate analysis to establish that the induction antibody was not an independent predictor of CMV infection/disease. Nor was higher average Tacrolimus blood concentration.
Data analysis
Modified intention-to-treat analysis
Trial registration
Clinicialtrials.gov - NCT01354301