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Everolimus‐facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2‐year results from the subgroup analysis of the TRANSFORM study

OBJECTIVE: We analyzed the efficacy and safety of an everolimus with reduced‐exposure calcineurin inhibitor (EVR+rCNI) versus mycophenolic acid with standard‐exposure CNI (MPA+sCNI) regimen in Asian patients from the TRANSFORM study. METHODS: In this 24‐month, open‐label study, de novo kidney transp...

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Autores principales: Watarai, Yoshihiko, Danguilan, Romina, Casasola, Concesa, Chang, Shen‐Shin, Ruangkanchanasetr, Prajej, Kee, Terence, Wong, Hin Seng, Kenmochi, Takashi, Amante, Angel Joaquin, Shu, Kuo‐Hsiung, Ingsathit, Atiporn, Bernhardt, Peter, Hernandez‐Gutierrez, Maria Pilar, Han, Duck Jong, Kim, Myoung Soo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9255374/
https://www.ncbi.nlm.nih.gov/pubmed/34216395
http://dx.doi.org/10.1111/ctr.14415
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author Watarai, Yoshihiko
Danguilan, Romina
Casasola, Concesa
Chang, Shen‐Shin
Ruangkanchanasetr, Prajej
Kee, Terence
Wong, Hin Seng
Kenmochi, Takashi
Amante, Angel Joaquin
Shu, Kuo‐Hsiung
Ingsathit, Atiporn
Bernhardt, Peter
Hernandez‐Gutierrez, Maria Pilar
Han, Duck Jong
Kim, Myoung Soo
author_facet Watarai, Yoshihiko
Danguilan, Romina
Casasola, Concesa
Chang, Shen‐Shin
Ruangkanchanasetr, Prajej
Kee, Terence
Wong, Hin Seng
Kenmochi, Takashi
Amante, Angel Joaquin
Shu, Kuo‐Hsiung
Ingsathit, Atiporn
Bernhardt, Peter
Hernandez‐Gutierrez, Maria Pilar
Han, Duck Jong
Kim, Myoung Soo
author_sort Watarai, Yoshihiko
collection PubMed
description OBJECTIVE: We analyzed the efficacy and safety of an everolimus with reduced‐exposure calcineurin inhibitor (EVR+rCNI) versus mycophenolic acid with standard‐exposure CNI (MPA+sCNI) regimen in Asian patients from the TRANSFORM study. METHODS: In this 24‐month, open‐label study, de novo kidney transplant recipients (KTxRs) were randomized (1:1) to receive EVR+rCNI or MPA+sCNI, along with induction therapy and corticosteroids. RESULTS: Of the 2037 patients randomized in the TRANSFORM study, 293 were Asian (EVR+rCNI, N = 136; MPA+sCNI, N = 157). At month 24, EVR+rCNI was noninferior to MPA+sCNI for the binary endpoint of estimated glomerular filtration rate (eGFR) < 50 ml/min/1.73 m(2) or treated biopsy‐proven acute rejection (27.0% vs. 29.2%, P = .011 for a noninferiority margin of 10%). Graft loss and death were reported for one patient each in both arms. Mean eGFR was higher in EVR+rCNI versus MPA+sCNI (72.2 vs. 66.3 ml/min/1.73 m(2), P = .0414) even after adjusting for donor type and donor age (64.3 vs. 59.3 ml/min/1.73 m(2), P = .0582). Overall incidence of adverse events was comparable. BK virus (4.4% vs. 12.1%) and cytomegalovirus (4.4% vs. 13.4%) infections were significantly lower in the EVR+rCNI arm. CONCLUSION: This subgroup analysis in Asian de novo KTxRs demonstrated that the EVR+rCNI versus MPA+sCNI regimen provides comparable antirejection efficacy, better renal function, and reduced viral infections (NCT01950819).
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spelling pubmed-92553742022-07-08 Everolimus‐facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2‐year results from the subgroup analysis of the TRANSFORM study Watarai, Yoshihiko Danguilan, Romina Casasola, Concesa Chang, Shen‐Shin Ruangkanchanasetr, Prajej Kee, Terence Wong, Hin Seng Kenmochi, Takashi Amante, Angel Joaquin Shu, Kuo‐Hsiung Ingsathit, Atiporn Bernhardt, Peter Hernandez‐Gutierrez, Maria Pilar Han, Duck Jong Kim, Myoung Soo Clin Transplant Original Articles OBJECTIVE: We analyzed the efficacy and safety of an everolimus with reduced‐exposure calcineurin inhibitor (EVR+rCNI) versus mycophenolic acid with standard‐exposure CNI (MPA+sCNI) regimen in Asian patients from the TRANSFORM study. METHODS: In this 24‐month, open‐label study, de novo kidney transplant recipients (KTxRs) were randomized (1:1) to receive EVR+rCNI or MPA+sCNI, along with induction therapy and corticosteroids. RESULTS: Of the 2037 patients randomized in the TRANSFORM study, 293 were Asian (EVR+rCNI, N = 136; MPA+sCNI, N = 157). At month 24, EVR+rCNI was noninferior to MPA+sCNI for the binary endpoint of estimated glomerular filtration rate (eGFR) < 50 ml/min/1.73 m(2) or treated biopsy‐proven acute rejection (27.0% vs. 29.2%, P = .011 for a noninferiority margin of 10%). Graft loss and death were reported for one patient each in both arms. Mean eGFR was higher in EVR+rCNI versus MPA+sCNI (72.2 vs. 66.3 ml/min/1.73 m(2), P = .0414) even after adjusting for donor type and donor age (64.3 vs. 59.3 ml/min/1.73 m(2), P = .0582). Overall incidence of adverse events was comparable. BK virus (4.4% vs. 12.1%) and cytomegalovirus (4.4% vs. 13.4%) infections were significantly lower in the EVR+rCNI arm. CONCLUSION: This subgroup analysis in Asian de novo KTxRs demonstrated that the EVR+rCNI versus MPA+sCNI regimen provides comparable antirejection efficacy, better renal function, and reduced viral infections (NCT01950819). John Wiley and Sons Inc. 2021-09-23 2021-10 /pmc/articles/PMC9255374/ /pubmed/34216395 http://dx.doi.org/10.1111/ctr.14415 Text en © 2021 Novartis Pharma AG. Clinical Transplantation published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Original Articles
Watarai, Yoshihiko
Danguilan, Romina
Casasola, Concesa
Chang, Shen‐Shin
Ruangkanchanasetr, Prajej
Kee, Terence
Wong, Hin Seng
Kenmochi, Takashi
Amante, Angel Joaquin
Shu, Kuo‐Hsiung
Ingsathit, Atiporn
Bernhardt, Peter
Hernandez‐Gutierrez, Maria Pilar
Han, Duck Jong
Kim, Myoung Soo
Everolimus‐facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2‐year results from the subgroup analysis of the TRANSFORM study
title Everolimus‐facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2‐year results from the subgroup analysis of the TRANSFORM study
title_full Everolimus‐facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2‐year results from the subgroup analysis of the TRANSFORM study
title_fullStr Everolimus‐facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2‐year results from the subgroup analysis of the TRANSFORM study
title_full_unstemmed Everolimus‐facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2‐year results from the subgroup analysis of the TRANSFORM study
title_short Everolimus‐facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2‐year results from the subgroup analysis of the TRANSFORM study
title_sort everolimus‐facilitated calcineurin inhibitor reduction in asian de novo kidney transplant recipients: 2‐year results from the subgroup analysis of the transform study
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9255374/
https://www.ncbi.nlm.nih.gov/pubmed/34216395
http://dx.doi.org/10.1111/ctr.14415
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