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Everolimus in de novo kidney transplant recipients participating in the Eurotransplant senior program: results of a prospective randomized multicenter study (SENATOR)

Early conversion to everolimus was assessed in kidney transplant recipients participating in the Eurotransplant Senior Program (ESP), a population in whom data are lacking. The SENATOR multicenter study enrolled 207 kidney transplant recipients undergoing steroid withdrawal at week 2 post-transplant...

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Main Authors: Brakemeier, Susanne (Author) , Arns, Wolfgang (Author) , Lehner, Frank (Author) , Witzke, Oliver (Author) , Vonend, Oliver (Author) , Sommerer, Claudia (Author) , Mühlfeld, Anja (Author) , Rath, Thomas (Author) , Schuhmann, Robert (Author) , Zukunft, Bianca (Author) , Kroeger, Irena (Author) , Porstner, Martina (Author) , Budde, Klemens (Author)
Format: Article (Journal)
Language:English
Published: September 19, 2019
In: PLOS ONE
Year: 2019, Volume: 14, Issue: 9
ISSN:1932-6203
DOI:10.1371/journal.pone.0222730
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1371/journal.pone.0222730
Verlag, lizenzpflichtig, Volltext: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0222730
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Author Notes:Susanne Brakemeier, Wolfgang Arns, Frank Lehner, Oliver Witzke, Oliver Vonend, Claudia Sommerer, Anja Mühlfeld, Thomas Rath, Robert Schuhmann, Bianca Zukunft, Irena Kroeger, Martina Porstner, Klemens Budde
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Summary:Early conversion to everolimus was assessed in kidney transplant recipients participating in the Eurotransplant Senior Program (ESP), a population in whom data are lacking. The SENATOR multicenter study enrolled 207 kidney transplant recipients undergoing steroid withdrawal at week 2 post-transplant (ClinicalTrials.gov [NCT00956293]). At week 7, patients were randomized (1:2 ratio) to continue the previous calcineurin inhibitor (CNI)-based regimen with mycophenolic acid (MPA) and cyclosporine or switch to a CNI-free regimen with MPA, everolimus (5-10 ng/mL) and basiliximab at weeks 7 and 12, then followed for 18 weeks to month 6 post-transplant. The primary endpoint was estimated GFR (eGFR). At week 7, 77/207 (37.2%) patients were randomized (53 everolimus, 24 control). At month 6, eGFR was comparable: 36.5±10.8ml/min with everolimus versus 42.0±13.0ml/min in the control group (p = 0.784). Discontinuation due to adverse events occurred in 27.8% of everolimus-treated patients and 0.0% of control patients (p = 0005). Efficacy profiles showed no difference. In conclusion, eGFR, safety and efficacy outcomes at month 6 post-transplant showed no difference between groups. The everolimus group experienced a higher rate of discontinuation due to adverse events. However, the high rate of non-randomization is highly relevant, indicating this to be a somewhat unstable patient population regardless of treatment.
Item Description:Gesehen am 14.04.2020
Physical Description:Online Resource
ISSN:1932-6203
DOI:10.1371/journal.pone.0222730

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