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Five-year outcomes in kidney transplant patients randomized to everolimus with cyclosporine withdrawal or low-exposure cyclosporine versus standard therapy

HERAKLES was a 1-year randomized, multicenter trial. Patients were randomized at 3 months after kidney transplantation to remain on cyclosporine-based therapy, switch to everolimus without a calcineurin inhibitor (CNI), or switch to everolimus with low-exposure cyclosporine. Overall, 417 of 497 (83....

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Main Authors: Sommerer, Claudia (Author) , Duerr, Michael (Author) , Witzke, Oliver (Author) , Lehner, Frank (Author) , Arns, Wolfgang (Author) , Kliem, Volker (Author) , Ackermann, Daniel (Author) , Guba, Markus (Author) , Jacobi, Johannes (Author) , Hauser, Ingeborg A. (Author) , Stahl, Rolf (Author) , Reinke, Petra (Author) , Rath, Thomas (Author) , Veit, Justyna (Author) , Mehrabi, Arianeb (Author) , Porstner, Martina (Author) , Budde, Klemens (Author)
Format: Article (Journal)
Language:English
Published: 02 May 2018
In: American journal of transplantation
Year: 2018, Volume: 18, Issue: 12, Pages: 2965-2976
ISSN:1600-6143
DOI:10.1111/ajt.14897
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1111/ajt.14897
Verlag, kostenfrei, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/ajt.14897
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Author Notes:Claudia Sommerer, Michael Duerr, Oliver Witzke, Frank Lehner, Wolfgang Arns, Volker Kliem, Daniel Ackermann, Markus Guba, Johannes Jacobi, Ingeborg A. Hauser, Rolf Stahl, Petra Reinke, Thomas Rath, Justyna Veit, Arianeb Mehrabi, Martina Porstner, Klemens Budde on behalf of the HERAKLES Study Group
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Summary:HERAKLES was a 1-year randomized, multicenter trial. Patients were randomized at 3 months after kidney transplantation to remain on cyclosporine-based therapy, switch to everolimus without a calcineurin inhibitor (CNI), or switch to everolimus with low-exposure cyclosporine. Overall, 417 of 497 (83.9%) patients from the core study entered a 4-year extension study. The randomized regimen was continued to year 5 in 75.9%, 41.9% and 24.6% of patients in the standard-CNI, CNI-free and low-CNI groups, respectively. Adjusted estimated GFR at year 5 was significantly higher in the CNI-free group versus standard CNI (difference 7.2 mL/min/1.73 m2, P < .001) or low CNI (difference 7.6 mL/min/1.73 m2, P < .001). For patients who continued randomized therapy for 5 years, differences were 14.4 mL/min/1.73 m2 and 10.1 mL/min/1.73 m2, respectively. Biopsy-proven acute rejection occurred during the 4-year extension study in 7.6%, 8.6%, and 9.0% of patients in the standard-CNI, CNI-free and low-CNI groups, respectively (P = .927). In conclusion, conversion to a CNI-free everolimus regimen 3 months after kidney transplantation improved long-term graft function, particularly in patients who continued the CNI-free regimen. Low CNI with everolimus did not improve renal function. Efficacy was comparable between groups but frequent immunosuppression changes should be taken into account.
Item Description:Gesehen am 27.03.2020
Physical Description:Online Resource
ISSN:1600-6143
DOI:10.1111/ajt.14897

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