High‐dose mizoribine combined with calcineurin inhibitor (cyclosporine or tacrolimus), basiliximab and corticosteroids for renal transplantation: A Japanese multicenter study

OBJECTIVE:To evaluate the utility and safety of high-dose mizoribinecombination therapy using cyclosporineand tacrolimusas calcineurininhibitors in patients undergoing kidney transplant. METHODS:The present study enrolled 156 patients who received kidney transplantsin 18 institutions between 2009 and 2013. ABO-incompatibleand/or pre-sensitized recipients were excluded. Immunosuppression used cyclosporine(88) or tacrolimus(68) as a calcineurininhibitor, and the dosage was adjusted based on blood concentrations. Mizoribinewas started at 6 mg/kg/day, and the target trough levelwas 1-2 ng/mL. Primary efficacy end-points of this study were 2-year patient survival, 2-year graft survival and the acute rejection ratewithin 2 years after transplantation. RESULTS:The 2-year patient and graft survival rates in the cyclosporinegroup were 98.9% and 94.3%, respectively, whereas those in the tacrolimusgroup were 100% and 98.5%, respectively, with no significant difference between groups. Rates of onset of rejection during the observation period were also equivalent, at 22.7% in the cyclosporinegroup and 17.6% in the tacrolimusgroup. Furthermore, groups showed no significant differences in transplanted renal function. No notable differences in adverse events were observed between groups. CONCLUSIONS:A regimen of high-dose mizoribinein combination with calcineurininhibitors basiliximab, and corticosteroids can provide effective immunosuppression while lowering the rate of cytomegalovirus infectionin kidney transplantpatients.