PURPOSE: To compare the clinical outcomes of mizoribine (MZR; 12 mg/kg/day) and mycophenolate mofetil (MMF; 2000 mg/day) in combination with tacrolimus (FK), basiliximab (SIM), and corticosteroids. We performed a prospective multi-center randomized comparative study of MZR (n = 41) and MMF (n = 42) in combination with FK, SIM, and MP for living donor renal transplantation.

PATIENTS: A total of 83 recipients who had undergone living donor renal transplantation between 2008 and 2013 were enrolled in this study. This prospective multi-institutional randomized comparative study compared MZR (n = 41) and MMF (n = 42) in combination with FK, SIM, and corticosteroids for living donor renal transplantation. We compared the AR and graft survival rates and adverse event rates within 1 year of renal transplantation between the two groups by using the intention-to-treat analysis.

RESULTS: During the 1-year observation period, the patient and graft survival rates were 100%. The AR rate was 17.1% in the MZR group and 19% in the MMF group. The incidence rate of cytomegalovirus infection (CMV) seropositivity (recipients/donor with CMV Ab status +/+) was higher in the MMF group than in the MZR group, although the difference in these rates was not statistically significant. The incidence of leucopenia was higher in the MZR group than in the MMF group. There was no significant difference in FK trough level at any post-transplantation point. No significant differences in dosages of MP were seen during the observation period. There were no significant differences in eGFR and BUN levels at any of the post-transplantation points. However, uric acid level was significant higher in the MZR group than in the MMF group immediately after transplantation. After transplantation, this gap between the two groups disappeared, probably due to the medications administered at each institution.

CONCLUSIONS: High-dose MZR 12 mg/kg/day was a safe and efficacious immunosuppressive alternative to MMF in living donor renal transplantation.

CITATION INFORMATION: Ishida H, Tanabe K, Takahara S, Amada N, Takahashi K, Toma H. A Prospective Randomized, Comparative Trial of High-Dose Mizoribine versus Mycophenolate Mofetil in Combination with Tacrolimus and Basiliximab for Living Donor Renal Transplantation: A Multi-Center Trial. Am J Transplant. 2016;16 (suppl 3).

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