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Long-term follow-up of five yr shows superior renal function with everolimus plus early calcineurin inhibitor withdrawal in the PROTECT randomized liver transplantation study

Standard

Long-term follow-up of five yr shows superior renal function with everolimus plus early calcineurin inhibitor withdrawal in the PROTECT randomized liver transplantation study. / Sterneck, Martina; Kaiser, Gernot M; Heyne, Nils; Richter, Nicolas; Rauchfuss, Falk; Pascher, Andreas; Schemmer, Peter; Fischer, Lutz; Klein, Christian G; Nadalin, Silvio; Lehner, Frank; Settmacher, Utz; Gotthardt, Daniel; Loss, Martin; Ladenburger, Stephan; Wimmer, Peter; Dworak, Markus; Schlitt, Hans J.

In: CLIN TRANSPLANT, Vol. 30, No. 6, 06.2016, p. 741-8.

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

Harvard

Sterneck, M, Kaiser, GM, Heyne, N, Richter, N, Rauchfuss, F, Pascher, A, Schemmer, P, Fischer, L, Klein, CG, Nadalin, S, Lehner, F, Settmacher, U, Gotthardt, D, Loss, M, Ladenburger, S, Wimmer, P, Dworak, M & Schlitt, HJ 2016, 'Long-term follow-up of five yr shows superior renal function with everolimus plus early calcineurin inhibitor withdrawal in the PROTECT randomized liver transplantation study', CLIN TRANSPLANT, vol. 30, no. 6, pp. 741-8. https://doi.org/10.1111/ctr.12744

APA

Sterneck, M., Kaiser, G. M., Heyne, N., Richter, N., Rauchfuss, F., Pascher, A., Schemmer, P., Fischer, L., Klein, C. G., Nadalin, S., Lehner, F., Settmacher, U., Gotthardt, D., Loss, M., Ladenburger, S., Wimmer, P., Dworak, M., & Schlitt, H. J. (2016). Long-term follow-up of five yr shows superior renal function with everolimus plus early calcineurin inhibitor withdrawal in the PROTECT randomized liver transplantation study. CLIN TRANSPLANT, 30(6), 741-8. https://doi.org/10.1111/ctr.12744

Vancouver

Sterneck M, Kaiser GM, Heyne N, Richter N, Rauchfuss F, Pascher A et al. Long-term follow-up of five yr shows superior renal function with everolimus plus early calcineurin inhibitor withdrawal in the PROTECT randomized liver transplantation study. CLIN TRANSPLANT. 2016 Jun;30(6):741-8. https://doi.org/10.1111/ctr.12744

Bibtex

@article{0737d96337bc4bf0a1dc8f307c492c5e,
title = "Long-term follow-up of five yr shows superior renal function with everolimus plus early calcineurin inhibitor withdrawal in the PROTECT randomized liver transplantation study",
abstract = "BACKGROUND: The 12-month (M) PROTECT study showed that de novo liver transplant recipients (LTxR) who switched from a calcineurin inhibitor (CNI)-based immunosuppression to a CNI-free everolimus (EVR)-based regimen showed numerically better renal function. Here, we present the five-yr follow-up data.METHODS: PROTECT was a randomized controlled study in which LTxR received basiliximab and CNI-based immunosuppression ± corticosteroids. Patients were randomized 1:1 to receive EVR or continue CNI. Patients completing the core study could enter the extension study on their randomized treatment.RESULTS: A total of 81 patients entered the extension study (41, EVR; 40, CNI). At M59 post-randomization, the adjusted mean eGFR was significantly higher in the EVR group, with a benefit of 12.4 mL/min using Cockcroft-Gault (95% CI: 1.2; 23.6; p = 0.0301). Also, there was a significant benefit for adjusted and unadjusted eGFR using the four-variable Modification of Diet in Renal Disease (MDRD4) or Nankivell formula. During the extension period, treatment failure rates were similar. SAEs occurred in 26 (63.4%) and 28 (70.0%) of the patients in EVR and CNI groups, respectively.CONCLUSION: Compared with the CNI-based treatment, EVR-based CNI-free immunosuppression resulted in significantly better renal function and comparable patient and graft outcomes after five-yr follow-up.",
keywords = "Journal Article",
author = "Martina Sterneck and Kaiser, {Gernot M} and Nils Heyne and Nicolas Richter and Falk Rauchfuss and Andreas Pascher and Peter Schemmer and Lutz Fischer and Klein, {Christian G} and Silvio Nadalin and Frank Lehner and Utz Settmacher and Daniel Gotthardt and Martin Loss and Stephan Ladenburger and Peter Wimmer and Markus Dworak and Schlitt, {Hans J}",
note = "{\textcopyright} 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.",
year = "2016",
month = jun,
doi = "10.1111/ctr.12744",
language = "English",
volume = "30",
pages = "741--8",
journal = "CLIN TRANSPLANT",
issn = "0902-0063",
publisher = "Wiley-Blackwell",
number = "6",

}

RIS

TY - JOUR

T1 - Long-term follow-up of five yr shows superior renal function with everolimus plus early calcineurin inhibitor withdrawal in the PROTECT randomized liver transplantation study

AU - Sterneck, Martina

AU - Kaiser, Gernot M

AU - Heyne, Nils

AU - Richter, Nicolas

AU - Rauchfuss, Falk

AU - Pascher, Andreas

AU - Schemmer, Peter

AU - Fischer, Lutz

AU - Klein, Christian G

AU - Nadalin, Silvio

AU - Lehner, Frank

AU - Settmacher, Utz

AU - Gotthardt, Daniel

AU - Loss, Martin

AU - Ladenburger, Stephan

AU - Wimmer, Peter

AU - Dworak, Markus

AU - Schlitt, Hans J

N1 - © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

PY - 2016/6

Y1 - 2016/6

N2 - BACKGROUND: The 12-month (M) PROTECT study showed that de novo liver transplant recipients (LTxR) who switched from a calcineurin inhibitor (CNI)-based immunosuppression to a CNI-free everolimus (EVR)-based regimen showed numerically better renal function. Here, we present the five-yr follow-up data.METHODS: PROTECT was a randomized controlled study in which LTxR received basiliximab and CNI-based immunosuppression ± corticosteroids. Patients were randomized 1:1 to receive EVR or continue CNI. Patients completing the core study could enter the extension study on their randomized treatment.RESULTS: A total of 81 patients entered the extension study (41, EVR; 40, CNI). At M59 post-randomization, the adjusted mean eGFR was significantly higher in the EVR group, with a benefit of 12.4 mL/min using Cockcroft-Gault (95% CI: 1.2; 23.6; p = 0.0301). Also, there was a significant benefit for adjusted and unadjusted eGFR using the four-variable Modification of Diet in Renal Disease (MDRD4) or Nankivell formula. During the extension period, treatment failure rates were similar. SAEs occurred in 26 (63.4%) and 28 (70.0%) of the patients in EVR and CNI groups, respectively.CONCLUSION: Compared with the CNI-based treatment, EVR-based CNI-free immunosuppression resulted in significantly better renal function and comparable patient and graft outcomes after five-yr follow-up.

AB - BACKGROUND: The 12-month (M) PROTECT study showed that de novo liver transplant recipients (LTxR) who switched from a calcineurin inhibitor (CNI)-based immunosuppression to a CNI-free everolimus (EVR)-based regimen showed numerically better renal function. Here, we present the five-yr follow-up data.METHODS: PROTECT was a randomized controlled study in which LTxR received basiliximab and CNI-based immunosuppression ± corticosteroids. Patients were randomized 1:1 to receive EVR or continue CNI. Patients completing the core study could enter the extension study on their randomized treatment.RESULTS: A total of 81 patients entered the extension study (41, EVR; 40, CNI). At M59 post-randomization, the adjusted mean eGFR was significantly higher in the EVR group, with a benefit of 12.4 mL/min using Cockcroft-Gault (95% CI: 1.2; 23.6; p = 0.0301). Also, there was a significant benefit for adjusted and unadjusted eGFR using the four-variable Modification of Diet in Renal Disease (MDRD4) or Nankivell formula. During the extension period, treatment failure rates were similar. SAEs occurred in 26 (63.4%) and 28 (70.0%) of the patients in EVR and CNI groups, respectively.CONCLUSION: Compared with the CNI-based treatment, EVR-based CNI-free immunosuppression resulted in significantly better renal function and comparable patient and graft outcomes after five-yr follow-up.

KW - Journal Article

U2 - 10.1111/ctr.12744

DO - 10.1111/ctr.12744

M3 - SCORING: Journal article

C2 - 27160359

VL - 30

SP - 741

EP - 748

JO - CLIN TRANSPLANT

JF - CLIN TRANSPLANT

SN - 0902-0063

IS - 6

ER -