Mizoribine versus mycophenolate mofetil in combination therapy with tacrolimus for de novo kidney transplantation: evaluation of efficacy and safety.
Ju MK, Huh KH, et al.Transplantation Proceedings 2013; 45(4): 1481-1486.
Aims
To compare the efficacy and safety of mizoribine (MZR) versus mycophenolate mofetil (MMF) in de novo kidney transplant patients.
Interventions
The MZR group received generic tacrolimus plus MZR and corticosteroids after induction therapy with basiliximab. The MMF group were administered with the same treatment except MMF was administered instead of MZR.
Participants
219 end stage renal failure participants undergoing de novo living or deceased donor kidney transplantation.
Outcomes
The primary outcome of the study was the incidence of BPAR ≥ grade 2 according to the Banff 07 criteria. The secondary outcomes included the incidence of efficacy failure defined as BPAR, graft loss, follow-up loss and patient death. In addition gastrointestinal symptom rating scale score and the gastrointestinal related quality of life index before and after transplantation were also included.
Follow-up
24 weeks.
CET Conclusions
In this randomised controlled trial comparing MZR with MMF in patients receiving deceased donor or living donor kidneys together with a generic form of tacrolimus there was no difference in either the efficacy or safety of mizoribine compared to MMF.
Data analysis
Strict intention-to-treat analysis
Trial registration
Not reported.