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

• Published in: International journal of urology Vol. 25; no. 2; pp. 141 - 145
• Main Authors: Nishioka, Tsukasa, Yoshimura, Norio, Ushigome, Hidetaka, Watarai, Yoshihiko, Nishimura, Kenji, Akioka, Kiyokazu, Nakamura, Nobuyuki, Kawakita, Mutsushi, Yuzawa, Kenji, Nakatani, Tatsuya
• Format: Journal Article
• Language: English
• Published: Australia Wiley Subscription Services, Inc 01.02.2018
• Subjects: ABO system; Adult; Basiliximab - administration & dosage; Basiliximab - adverse effects; Blood groups; Calcineurin; Calcineurin inhibitors; Calcineurin Inhibitors - administration & dosage; Calcineurin Inhibitors - adverse effects; combination therapy; Corticosteroids; Cyclosporine - administration & dosage; Cyclosporine - adverse effects; Cyclosporins; Cytomegalovirus; Drug Therapy, Combination - adverse effects; Drug Therapy, Combination - methods; Female; Glucocorticoids - administration & dosage; Graft rejection; Graft Rejection - epidemiology; Graft Rejection - immunology; Graft Rejection - prevention & control; Graft Survival - drug effects; Graft Survival - immunology; Humans; Immunosuppression; Immunosuppressive Agents - administration & dosage; Immunosuppressive Agents - adverse effects; Immunotherapy; Kidney Failure, Chronic - mortality; Kidney Failure, Chronic - surgery; Kidney transplantation; Kidney Transplantation - adverse effects; Male; Middle Aged; mizoribine; Monoclonal antibodies; Patients; Renal function; renal transplantation; Ribonucleosides - administration & dosage; Ribonucleosides - adverse effects; Survival; Survival Rate; Tacrolimus; Tacrolimus - administration & dosage; Tacrolimus - adverse effects; Transplants & implants; Treatment Outcome; combination therapy; cytomegalovirus; renal transplantation; mizoribine; calcineurin inhibitors
• ISSN: 0919-8172; 1442-2042
• DOI: 10.1111/iju.13476

Objective To evaluate the utility and safety of high‐dose mizoribine combination therapy using cyclosporine and tacrolimus as calcineurin inhibitors in patients undergoing kidney transplant. Methods The present study enrolled 156 patients who received kidney transplants in 18 institutions between 2009 and 2013. ABO‐incompatible and/or pre‐sensitized recipients were excluded. Immunosuppression used cyclosporine (88) or tacrolimus (68) as a calcineurin inhibitor, and the dosage was adjusted based on blood concentrations. Mizoribine was started at 6 mg/kg/day, and the target trough level was 1–2 ng/mL. Primary efficacy end‐points of this study were 2‐year patient survival, 2‐year graft survival and the acute rejection rate within 2 years after transplantation. Results The 2‐year patient and graft survival rates in the cyclosporine group were 98.9% and 94.3%, respectively, whereas those in the tacrolimus group 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 cyclosporine group and 17.6% in the tacrolimus group. 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 mizoribine in combination with calcineurin inhibitors basiliximab, and corticosteroids can provide effective immunosuppression while lowering the rate of cytomegalovirus infection in kidney transplant patients.