Randomized comparative trial of mizoribine versus mycophenolate mofetil in combination with tacrolimus for living donor renal transplantation.
Takahara S, Takahashi K, et al.Clinical and Experimental Nephrology [record in progress].
Aims
To compare whether an increased mizoribine (MZR) dosage has similar efficacy of mycophenolate mofetil (MMF) in renal transplant patients.
Interventions
Patients were administered with MZR or MMF. MZR and MMF, doses started at 12mg/kg/day and 2g/day respectively. MZR was divided into morning and afternoon doses and gradually reduced from 2 months onward, with a mean dose of 350mg/day after one year. MMF was also administered as morning and afternoon doses and gradually reduced from two weeks. Tacrolimus and steroids (excluding basiliximab) were administered according to the protocol of each institution. Tacrolimus dosage in the early stage after transplantation was 0.08-0.12mg/kg/day.
Participants
: 35 living donor renal transplant recipients.
Outcomes
The primary endpoint was the rejection-free rate at one year after transplantation. Secondary endpoints included patient survival, graft survival rate and incidence of adverse events during the first year after transplantation.
Follow-up
12 months.
CET Conclusions
In this small multicentre trial Mizoribine(MZR) was used with tacrolimus and steroids in a high dose, namely 6mg twice a day, and compared with mycophenolate, again used with tacrolimus and steroids. The trial was really underpowered but in the 37 patients randomised there was no difference in rejection rate, patient survival or graft survival and obviously this warrants further study. We noted that a multicentre randomised trial, but with basiliximab induction, is in progress.
Data analysis
Per protocol analysis
Trial registration
Not reported.