Efficacy and Safety of Mizoribine Combined With Tacrolimus in Living Donor Kidney Transplant Recipients: 3-Year Results by a Chinese Single Center Study.

Mizoribine (MZR) was effective and safe for living Chinese donor kidney transplantation (LDKT) on tacrolimus-based treatment 1 year after transplantation. We investigated whether MZR was effective and safe for LDKT on tacrolimus-based treatment with long follow-up periods. We compared 22 LDKT recipients who were administered MZR, tacrolimus, and corticosteroids with a control group (n = 20) treated with mycophenolate mofetil (MMF), tacrolimus, and corticosteroids. Primary efficacy endpoints were 3-year patient survival, 3-year graft survival, and acute rejection (AR) rate within 3 years after transplantation. The 3-year patient and graft survival rates for the MZR and MMF groups were 100%. The AR rate after transplantation was 18.2% for the MZR group and 10.0% for the MMF group; the difference was not significant (P = .665). There was no significant difference in serum creatinine levels, glomerular filtration rates (eGFR), serum urate levels, blood urea nitrogen, and cystatin C levels 12, 24, and 36 months after transplantation. No significant differences in the CD3, CD4, CD8, CD4/CD8, and CD45 were observed between the 2 groups 12, 24, and 36 months after transplantation. There were no significant differences in adverse events among the MZR or the MMF group, whereas the prevalence of gastrointestinal symptoms were significantly lower in the MZR treatment group (P = .003), especially acid reflux (P = .007). Compared with the MMF group, the MZR group should lighten the burden on patients. MZR with tacrolimus and corticosteroids provides satisfactory immunosuppression and higher safety for Chinese LDKT over a 3-year follow-up.

Shi Y ，Liu H ，Chen XG ，Shen ZY ... -  《-》

Comparison of Mizoribine and Mycophenolate Mofetil With a Tacrolimus-Based Immunosuppressive Regimen in Living-Donor Kidney Transplantation Recipients: A Retrospective Study in China.

A retrospective study was conducted to investigate the prevalence of gastrointestinal (GI) symptoms as well as the efficacy and safety of mizoribine (MZR) and mycophenolate mofetil (MMF) in Chinese living-donor kidney transplantation (LDKT). Forty-two recipients enrolled between January 2012 and March 2014 were treated with either MZR (n = 22) or MMF (n = 20). All patients were treated in combination with a tacrolimus-based immunosuppressive regimen, besides the study drugs. GI symptoms were observed in 1 of 22 patients (4.5%) and 10 of 20 patients (50%) in MZR treatment group and MMF treatment group, respectively (P = .001), during the post-transplantation 1 year. No significant differences in the incidence of acid reflux, bloated stomach feeling, and constipation were observed between the two groups. No recipient developed diarrhea in the MZR treatment group, whereas 30% of the MMF treatment group developed diarrhea (P = .007). The averages of GI symptom severity total score and diarrhea score were significantly lower in the MZR treatment group compare with MMF treatment group. There were no inter-group differences in background characteristics. There were no significant differences in acute rejection rate and clinical findings between these two groups, whereas the prevalence of cytomegalovirus infection and leukopenia were significantly lower in the MZR treatment group. There was no significant difference on adverse events such as hyperuricemia or other adverse events. This study demonstrated a significantly lower incidence of GI symptoms for treatment with MZR compared with MMF and good efficacy and safety in Chinese LDKT with MZR.

Shi Y ，Liu H ，Chen XG ，Shen ZY ... -  《-》

Efficacy and Safety of a Quadruple Regimen Compared with Triple Regimens in Patients with Mycophenolic Acid-Related Gastrointestinal Complications After Renal Transplantation: A Short-Term Single-Center Study.

Peng Z ，Xian W ，Sun H ，Li E ，Geng L ，Tian J ... -  《-》

Randomized comparative trial of mizoribine versus mycophenolate mofetil in combination with tacrolimus for living donor renal transplantation.

Takahara S ，Takahashi K ，Akiyama T ，Uchida K ，Tanabe K ，Amada N ，Toma H ... -  《-》

The efficacy and safety of high-dose mizoribine in ABO-incompatible kidney transplantation using anti-CD20 and anti-CD25 antibody without splenectomy treatment.

Mizoribine (MZR) has been developed as an immunosuppressive agent in Japan, but it shows less potent immunosuppressive effects at doses up to 3 mg/kg/d. In this study, we investigated whether high-dose MZR (6 mg/kg/d) was effective for ABO-incompatible (ABO-i) living donor kidney transplantation (LKT) using treatment with anti-CD25 and anti-CD20 monoclonal antibodies without splenectomy. Since 2007, we encountered 24 cases of ABO-i LKT using anti-CD20 and anti-CD25 monoclonal antibody without splenectomy. The pretransplant immunosuppressive regimen consisted of two doses of anti-CD20 antibody, mycophenolate mofetil (MMF), prednisolone, a calcineurin inhibitor (cyclosporine [7 mg/kg] or tacrolimus [0.2 mg/kg] and two doses of anti-CD25 antibody. Antibody removal by plasmapheresis was performed before LKT up to several times according to the antibody titer. The posttransplant regimen consisted of high-dose mizoribine (6 mg/kg/d) instead of MMF (MZR group, n = 12). The 1-year graft survival rates for the MZR and MMF groups were both 100%. The rejection rate in the MZR group (eight %) was not significantly higher than that in the MMF group (seventeen %) Serum creatinine level was not significantly different between the two groups. In the MZR group 6 (50%) patients developed CMV antigenemia-positivity versus 11 (92%) in the MMF group (P < .05). The number of patients who developed CMV disease was 0 in the MZR group and 1 (8%) in the MMF group. The number of patients treated with ganciclovir was 0% and 8%, respectively (not significant). We obtain good clinical results with high-dose MZR in ABO-i LKT using anti-CD20 and anti-CD25 antibody treatment without splenectomy.

Yoshimura N ，Ushigome H ，Matsuyama M ，Nobori S ，Suzuki T ，Sakai K ，Okajima H ，Okamoto M ... -  《-》