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  • Title: High rejection rate during calcineurin inhibitor-free and early steroid withdrawal immunosuppression in renal transplantation.
    Author: Gelens MA, Christiaans MH, van Heurn EL, van den Berg-Loonen EP, Peutz-Kootstra CJ, van Hooff JP.
    Journal: Transplantation; 2006 Nov 15; 82(9):1221-3. PubMed ID: 17102775.
    Abstract:
    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.
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