Additional members of the SMART study group: Wolf-Dieter Illner (Department of Surgery, Zentralklinikum Augsburg, Germany, Karl Fehnle (ALGORA München, Germany), Michael Eder (Department of Surgery, Munich University Hospital, Campus Grosshadern, Munich, Germany), Constanze Nohr-Luczak (Department of Urology, University of Rostock, Rostock, Germany).
Early conversion to a sirolimus-based, calcineurin-inhibitor-free immunosuppression in the SMART trial: observational results at 24 and 36 months after transplantation
Article first published online: 10 FEB 2012
© 2012 The Authors. Transplant International © 2012 European Society for Organ Transplantation
Volume 25, Issue 4, pages 416–423, April 2012
How to Cite
Guba, M., Pratschke, J., Hugo, C., Krämer, B. K., Pascher, A., Pressmar, K., Hakenberg, O., Fischereder, M., Brockmann, J., Andrassy, J., Banas, B., Jauch, K.-W. and for the SMART-Study Group* (2012), Early conversion to a sirolimus-based, calcineurin-inhibitor-free immunosuppression in the SMART trial: observational results at 24 and 36 months after transplantation. Transplant International, 25: 416–423. doi: 10.1111/j.1432-2277.2012.01432.x
Conflicts of interest No conflict of interest to disclose for all authors.
- Issue published online: 14 MAR 2012
- Article first published online: 10 FEB 2012
- Received: 17 September 2011 Revision requested: 14 October 2011 Accepted: 11 January 2012
- calcineurin-inhibitor-free immunosuppression;
- kidney transplantation;
- mammalian target of rapamycin;
Early conversion to a calcineurin-inhibitor (CNI)-free maintenance immunosuppression with sirolimus (SRL), mycophenolate mofetil (MMF) and steroids was associated with an improved 1-year renal function as compared with a cyclosporine (CsA)-based regimen (SMART core-study). This observational follow-up describes 132 patients followed up within the SMART study framework for 36 months. At 36 months, renal function continued to be superior in SRL-treated patients [ITT-eGFR@36m: 60.88 vs. 53.72 (CsA) ml/min/1.73 m2, P = 0.031]. However, significantly more patients discontinued therapy in the SRL group 59.4% vs.42.3% (CsA). Patient [99% (SRL) vs.97% (CsA) and graft 96% (SRL) vs.94% (CsA)] survival at 36 months was excellent in both arms. There was no difference in late rejection episodes. Late infections and adverse events were similar in both arms except of a higher rate of hyperlipidemia in SRL and a higher incidence of malignancy in CsA-treated patients. In a multivariate analysis, donor age >60 years, S-creatinine at conversion >2 mg/dl, CMV naïve(-) recipients and immunosuppression with CsA were predictive of an impaired renal function at 36 months. Early conversion to a CNI-free SRL-based immunosuppression is associated with a sustained improvement of renal function up to 36 months after transplantation. Patient selection will be key to derive long-term benefit and avoid treatment failure using this mTOR-inhibitor-based immunosuppressive regimen.