Morbidity and mortality due to cardiovascular disease are major problems after renal transplantation. The effects of three immunosuppressive protocols on cardiovascular end points were investigated in a single-center, randomized, parallel (1-1-1) group. Acute rejection was a secondary safety endpoint. Groups were as follows: group one, tacrolimus+sirolimus; group two, tacrolimus+mycophenolate mofetil (MMF); group three, sirolimus+MMF+daclizumab. All groups received two days methylprednisolone only. The Ethical Committee demanded an interim analysis when 50% of the patients were included. In this analysis, 54 patients with a median follow-up of 9.2 months were studied. The Kaplan-Meyer analysis showed a difference in rejection free survival between group one (82%) and group three (34%, P=0.03) and between groups one and two (tacrolimus-based, 76%) and group three (calcineurin-free, 34%, P=0.04). Calcineurin-free immunosuppression with two days of steroids only showed an unacceptable high incidence of acute rejection and re-rejection, and the study had to be stopped.
Gelens, M. A., Christiaans, M. H., van Heurn, L. W. E., van de Berg-Loonen, E. P., Peutz-Kootstra, C. J., & van Hooff, J. P. (2006). High rejection rate during calcineurin inhibitor-free and early steroid withdrawal immunosuppression in renal transplantation. Transplantation, 82(9), 1221-1223. https://doi.org/10.1097/01.tp.0000232688.76018.19