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

Standard

Five-year outcomes in kidney transplant patients randomized to everolimus with cyclosporine withdrawal or low-exposure cyclosporine versus standard therapy. / Sommerer, Claudia; Duerr, Michael; Witzke, Oliver; Lehner, Frank; Arns, Wolfgang; Kliem, Volker; Ackermann, Daniel; Guba, Markus; Jacobi, Johannes; Hauser, Ingeborg A; Stahl, Rolf; Reinke, Petra; Rath, Thomas; Veit, Justyna; Mehrabi, Arianeb; Porstner, Martina; Budde, Klemens; HERAKLES Study Group.

In: AM J TRANSPLANT, Vol. 18, No. 12, 12.2018, p. 2965-2976.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Sommerer, C, Duerr, M, Witzke, O, Lehner, F, Arns, W, Kliem, V, Ackermann, D, Guba, M, Jacobi, J, Hauser, IA, Stahl, R, Reinke, P, Rath, T, Veit, J, Mehrabi, A, Porstner, M, Budde, K & HERAKLES Study Group 2018, 'Five-year outcomes in kidney transplant patients randomized to everolimus with cyclosporine withdrawal or low-exposure cyclosporine versus standard therapy', AM J TRANSPLANT, vol. 18, no. 12, pp. 2965-2976. https://doi.org/10.1111/ajt.14897

APA

Sommerer, C., Duerr, M., Witzke, O., Lehner, F., Arns, W., Kliem, V., Ackermann, D., Guba, M., Jacobi, J., Hauser, I. A., Stahl, R., Reinke, P., Rath, T., Veit, J., Mehrabi, A., Porstner, M., Budde, K., & HERAKLES Study Group (2018). Five-year outcomes in kidney transplant patients randomized to everolimus with cyclosporine withdrawal or low-exposure cyclosporine versus standard therapy. AM J TRANSPLANT, 18(12), 2965-2976. https://doi.org/10.1111/ajt.14897

Vancouver

Sommerer C, Duerr M, Witzke O, Lehner F, Arns W, Kliem V et al. Five-year outcomes in kidney transplant patients randomized to everolimus with cyclosporine withdrawal or low-exposure cyclosporine versus standard therapy. AM J TRANSPLANT. 2018 Dec;18(12):2965-2976. https://doi.org/10.1111/ajt.14897

Bibtex

@article{22121a1da3bf4d2e9f6d6d7cf241f03e,
title = "Five-year outcomes in kidney transplant patients randomized to everolimus with cyclosporine withdrawal or low-exposure cyclosporine versus standard therapy",
abstract = "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.",
keywords = "Journal Article",
author = "Claudia Sommerer and Michael Duerr and Oliver Witzke and Frank Lehner and Wolfgang Arns and Volker Kliem and Daniel Ackermann and Markus Guba and Johannes Jacobi and Hauser, {Ingeborg A} and Rolf Stahl and Petra Reinke and Thomas Rath and Justyna Veit and Arianeb Mehrabi and Martina Porstner and Klemens Budde and {HERAKLES Study Group}",
note = "{\textcopyright} 2018 The American Society of Transplantation and the American Society of Transplant Surgeons.",
year = "2018",
month = dec,
doi = "10.1111/ajt.14897",
language = "English",
volume = "18",
pages = "2965--2976",
journal = "AM J TRANSPLANT",
issn = "1600-6135",
publisher = "Wiley-Blackwell",
number = "12",

}

RIS

TY - JOUR

T1 - Five-year outcomes in kidney transplant patients randomized to everolimus with cyclosporine withdrawal or low-exposure cyclosporine versus standard therapy

AU - Sommerer, Claudia

AU - Duerr, Michael

AU - Witzke, Oliver

AU - Lehner, Frank

AU - Arns, Wolfgang

AU - Kliem, Volker

AU - Ackermann, Daniel

AU - Guba, Markus

AU - Jacobi, Johannes

AU - Hauser, Ingeborg A

AU - Stahl, Rolf

AU - Reinke, Petra

AU - Rath, Thomas

AU - Veit, Justyna

AU - Mehrabi, Arianeb

AU - Porstner, Martina

AU - Budde, Klemens

AU - HERAKLES Study Group

N1 - © 2018 The American Society of Transplantation and the American Society of Transplant Surgeons.

PY - 2018/12

Y1 - 2018/12

N2 - 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.

AB - 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.

KW - Journal Article

U2 - 10.1111/ajt.14897

DO - 10.1111/ajt.14897

M3 - SCORING: Journal article

C2 - 29722128

VL - 18

SP - 2965

EP - 2976

JO - AM J TRANSPLANT

JF - AM J TRANSPLANT

SN - 1600-6135

IS - 12

ER -