A randomized trial with steroids and antithymocyte globulins comparing cyclosporine/Azathioprine versus tacrolimus/mycophenolate mofetil (CATM2) in renal transplantation.
Vacher-Coponat H, Moal V, et al.Transplantation 93(4):437-43, 2012.
Aims
To compare the efficacy of tacrolimus/mycophenolate mofetil versus cyclosporine/azathioprine in patients receiving rabbit antithymocyte globulins and steroids.
Interventions
Tacrolimus combined with mycophenolate mofetil versus cyclosporine combined with azathioprine. All patients were treated with antithymocyte globulins together with steroids.
Participants
300 kidney transplant recipients.
Outcomes
Primary outcome was the number of patients with clinically suspected acute rejection at 1 year. Secondary outcomes were the number of patients with biopsy-proven acute rejection, estimated glomerular filtration rate (eGFR), patient and graft survival, and adverse events at 1 and 3 years.
Follow-up
3 years
CET Conclusions
In this quite large, good quality study, there was no difference in clinically suspected acute rejection but there was a reduction in biopsy proven acute rejection in the tacrolimus/MMF arm. The eGFR was higher in the Tac/MMF group. The difference between the two interventions is modest and one would have liked to have seen perhaps a third or fourth group combining Tac with azathioprine and cyclosporine with MMF. Thus the evidence that induction with ATG and maintenance therapy with Tac plus MMF plus steroids is superior to maintenance with cyclosporine plus azathiaprine plus steroids is modest in this study.
Data analysis
Modified intention-to-treat analysis
Trial registration
Not reported