(Aims) Mizoribine (MZR) has been developed as an immunosuppressive agent, but has a less potent immunosuppressive effect up to 3 mg/kg/day. The widespread use of a 4-drug immunosuppressive therapy (Basiliximab, calcineurin inhibitor, steroid and MMF) has markedly lowered the rate of acute rejection,but infections, particularly those involving cytomegalovirus (CMV), have become an issue. Therefore, we investigated and reported high-dose MZR, at 6 mg/kg/day, was effective and safe for kidney transplant patients in conjunction with cyclosporine (CsA), Bas and corticosteroid by a japanese multicenter study for 2 years.

(Methods) A total of 90 patients were treated with MZR (6 mg/kg), CsA, Bas and corticosteroid. CsA was started at a dose of 7 mg/kg to maintain blood levels in the target therapeutic range: 200 ng/ml (CO), l,200 ng/ml (C2) and 6,000 ng•hr/ml (AUC_0-9). MZR was adjusted to maintain a target CO level of 1-2 Μg/ml. CMV antigenemia (C7-HRP) was measured every two week for 6 mo.

(Results) Patients and grafts survival rate for 2 years was 98.9%. The acute rejection rate for 2 years was 22.2%. The mean serum creatinine level was 1.52±0.61 mg/dl at 1 year and 1.51±0.59 mg/dl at 2 years. The incidence of CMV disease was 0%, the positive rate of CMV antigenemia 28.9% and the rate of ganciclovir treatment 5.6%. The mean serum uric acid level was 6.79±1.39 mg/dl at 1 year and 6.45±1.24 mg/dl at 2 years. The number of patients treated with allopurinol was 25( 27.8%) of 90 patients. Bone marrow suppression was never seen and liver dysfunction was developed in 3(3.3%) of patients.

(Conclusion) A regimen of high-dose MZR in combination with CsA, Bas, and steroid can establish not only satisfactory immunosuppression but also low rate of CMV infection in vivo.

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