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

Transplant Proc. 2019 Jun;51(5):1337-1342. doi: 10.1016/j.transproceed.2019.03.014.

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: MZR with tacrolimus and corticosteroids provides satisfactory immunosuppression and higher safety for Chinese LDKT over a 3-year follow-up.

Publication types

  • Clinical Trial

MeSH terms

  • Adrenal Cortex Hormones / administration & dosage
  • Adult
  • Drug Therapy, Combination
  • Female
  • Graft Rejection / prevention & control
  • Graft Survival
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Kidney Transplantation* / methods
  • Living Donors
  • Male
  • Middle Aged
  • Mycophenolic Acid / therapeutic use
  • Ribonucleosides / therapeutic use*
  • Tacrolimus / therapeutic use

Substances

  • Adrenal Cortex Hormones
  • Immunosuppressive Agents
  • Ribonucleosides
  • mizoribine
  • Mycophenolic Acid
  • Tacrolimus