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An open-label, randomized trial indicates that everolimus with tacrolimus or cyclosporine is comparable to standard immunosuppression in de novo kidney transplant patients

Standard

An open-label, randomized trial indicates that everolimus with tacrolimus or cyclosporine is comparable to standard immunosuppression in de novo kidney transplant patients. / Sommerer, Claudia; Suwelack, Barbara; Dragun, Duska; Schenker, Peter; Hauser, Ingeborg A; Witzke, Oliver; Hugo, Christian; Kamar, Nassim; Merville, Pierre; Junge, Martina; Thaiss, Friedrich; Nashan, Björn; Athena Study Group.

In: KIDNEY INT, Vol. 96, No. 1, 07.2019, p. 231-244.

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

Harvard

Sommerer, C, Suwelack, B, Dragun, D, Schenker, P, Hauser, IA, Witzke, O, Hugo, C, Kamar, N, Merville, P, Junge, M, Thaiss, F, Nashan, B & Athena Study Group 2019, 'An open-label, randomized trial indicates that everolimus with tacrolimus or cyclosporine is comparable to standard immunosuppression in de novo kidney transplant patients', KIDNEY INT, vol. 96, no. 1, pp. 231-244. https://doi.org/10.1016/j.kint.2019.01.041

APA

Sommerer, C., Suwelack, B., Dragun, D., Schenker, P., Hauser, I. A., Witzke, O., Hugo, C., Kamar, N., Merville, P., Junge, M., Thaiss, F., Nashan, B., & Athena Study Group (2019). An open-label, randomized trial indicates that everolimus with tacrolimus or cyclosporine is comparable to standard immunosuppression in de novo kidney transplant patients. KIDNEY INT, 96(1), 231-244. https://doi.org/10.1016/j.kint.2019.01.041

Vancouver

Sommerer C, Suwelack B, Dragun D, Schenker P, Hauser IA, Witzke O et al. An open-label, randomized trial indicates that everolimus with tacrolimus or cyclosporine is comparable to standard immunosuppression in de novo kidney transplant patients. KIDNEY INT. 2019 Jul;96(1):231-244. https://doi.org/10.1016/j.kint.2019.01.041

Bibtex

@article{eeb03c214e9f4258bfd6bc3d1edb814b,
title = "An open-label, randomized trial indicates that everolimus with tacrolimus or cyclosporine is comparable to standard immunosuppression in de novo kidney transplant patients",
abstract = "This is a randomized trial (ATHENA study) in de novo kidney transplant patients to compare everolimus versus mycophenolic acid (MPA) with similar tacrolimus exposure in both groups, or everolimus with concomitant tacrolimus or cyclosporine (CsA), in an unselected population. In this 12-month, multicenter, open-label study, de novo kidney transplant recipients were randomized to everolimus with tacrolimus (EVR/TAC), everolimus with CsA (EVR/CsA) or MPA with tacrolimus (MPA/TAC), with similar tacrolimus exposure in both groups. Non-inferiority of the primary end point (estimated glomerular filtration rate [eGFR] at month 12), assessed in the per-protocol population of 338 patients, was not shown for EVR/TAC or EVR/CsA versus MPA/TAC. In 123 patients with TAC levels within the protocol-specified range, eGFR outcomes were comparable between groups. The mean increase in eGFR during months 1 to 12 post-transplant, analyzed post hoc, was similar with EVR/TAC or EVR/CsA versus MPA/TAC. The incidence of treatment failure (biopsy proven acute rejection, graft loss or death) was not significant for EVR/TAC but significant for EVR/CsA versus MPA/TAC. Most biopsy-proven acute rejection events in this study were graded mild (BANFF IA). There were no differences in proteinuria between groups. Cytomegalovirus and BK virus infection were significantly more frequent with MPA/TAC. Thus, everolimus with TAC or CsA showed comparable efficacy to MPA/TAC in de novo kidney transplant patients. Non-inferiority of renal function, when pre-specified, was not shown, but the mean increase in eGFR from month 1 to 12 was comparable to MPA/TAC.",
author = "Claudia Sommerer and Barbara Suwelack and Duska Dragun and Peter Schenker and Hauser, {Ingeborg A} and Oliver Witzke and Christian Hugo and Nassim Kamar and Pierre Merville and Martina Junge and Friedrich Thaiss and Bj{\"o}rn Nashan and {Athena Study Group}",
note = "Copyright {\textcopyright} 2019 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.",
year = "2019",
month = jul,
doi = "10.1016/j.kint.2019.01.041",
language = "English",
volume = "96",
pages = "231--244",
journal = "KIDNEY INT",
issn = "0085-2538",
publisher = "NATURE PUBLISHING GROUP",
number = "1",

}

RIS

TY - JOUR

T1 - An open-label, randomized trial indicates that everolimus with tacrolimus or cyclosporine is comparable to standard immunosuppression in de novo kidney transplant patients

AU - Sommerer, Claudia

AU - Suwelack, Barbara

AU - Dragun, Duska

AU - Schenker, Peter

AU - Hauser, Ingeborg A

AU - Witzke, Oliver

AU - Hugo, Christian

AU - Kamar, Nassim

AU - Merville, Pierre

AU - Junge, Martina

AU - Thaiss, Friedrich

AU - Nashan, Björn

AU - Athena Study Group

N1 - Copyright © 2019 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.

PY - 2019/7

Y1 - 2019/7

N2 - This is a randomized trial (ATHENA study) in de novo kidney transplant patients to compare everolimus versus mycophenolic acid (MPA) with similar tacrolimus exposure in both groups, or everolimus with concomitant tacrolimus or cyclosporine (CsA), in an unselected population. In this 12-month, multicenter, open-label study, de novo kidney transplant recipients were randomized to everolimus with tacrolimus (EVR/TAC), everolimus with CsA (EVR/CsA) or MPA with tacrolimus (MPA/TAC), with similar tacrolimus exposure in both groups. Non-inferiority of the primary end point (estimated glomerular filtration rate [eGFR] at month 12), assessed in the per-protocol population of 338 patients, was not shown for EVR/TAC or EVR/CsA versus MPA/TAC. In 123 patients with TAC levels within the protocol-specified range, eGFR outcomes were comparable between groups. The mean increase in eGFR during months 1 to 12 post-transplant, analyzed post hoc, was similar with EVR/TAC or EVR/CsA versus MPA/TAC. The incidence of treatment failure (biopsy proven acute rejection, graft loss or death) was not significant for EVR/TAC but significant for EVR/CsA versus MPA/TAC. Most biopsy-proven acute rejection events in this study were graded mild (BANFF IA). There were no differences in proteinuria between groups. Cytomegalovirus and BK virus infection were significantly more frequent with MPA/TAC. Thus, everolimus with TAC or CsA showed comparable efficacy to MPA/TAC in de novo kidney transplant patients. Non-inferiority of renal function, when pre-specified, was not shown, but the mean increase in eGFR from month 1 to 12 was comparable to MPA/TAC.

AB - This is a randomized trial (ATHENA study) in de novo kidney transplant patients to compare everolimus versus mycophenolic acid (MPA) with similar tacrolimus exposure in both groups, or everolimus with concomitant tacrolimus or cyclosporine (CsA), in an unselected population. In this 12-month, multicenter, open-label study, de novo kidney transplant recipients were randomized to everolimus with tacrolimus (EVR/TAC), everolimus with CsA (EVR/CsA) or MPA with tacrolimus (MPA/TAC), with similar tacrolimus exposure in both groups. Non-inferiority of the primary end point (estimated glomerular filtration rate [eGFR] at month 12), assessed in the per-protocol population of 338 patients, was not shown for EVR/TAC or EVR/CsA versus MPA/TAC. In 123 patients with TAC levels within the protocol-specified range, eGFR outcomes were comparable between groups. The mean increase in eGFR during months 1 to 12 post-transplant, analyzed post hoc, was similar with EVR/TAC or EVR/CsA versus MPA/TAC. The incidence of treatment failure (biopsy proven acute rejection, graft loss or death) was not significant for EVR/TAC but significant for EVR/CsA versus MPA/TAC. Most biopsy-proven acute rejection events in this study were graded mild (BANFF IA). There were no differences in proteinuria between groups. Cytomegalovirus and BK virus infection were significantly more frequent with MPA/TAC. Thus, everolimus with TAC or CsA showed comparable efficacy to MPA/TAC in de novo kidney transplant patients. Non-inferiority of renal function, when pre-specified, was not shown, but the mean increase in eGFR from month 1 to 12 was comparable to MPA/TAC.

U2 - 10.1016/j.kint.2019.01.041

DO - 10.1016/j.kint.2019.01.041

M3 - SCORING: Journal article

C2 - 31027892

VL - 96

SP - 231

EP - 244

JO - KIDNEY INT

JF - KIDNEY INT

SN - 0085-2538

IS - 1

ER -