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Everolimus with Red...
Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation.
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Pascual, Julio (författare)
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Berger, Stefan P (författare)
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Witzke, Oliver (författare)
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Tedesco, Helio (författare)
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Mulgaonkar, Shamkant (författare)
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Qazi, Yasir (författare)
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Chadban, Steven (författare)
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Oppenheimer, Federico (författare)
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Sommerer, Claudia (författare)
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Oberbauer, Rainer (författare)
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Watarai, Yoshihiko (författare)
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Legendre, Christophe (författare)
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Citterio, Franco (författare)
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Henry, Mitchell (författare)
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Srinivas, Titte R (författare)
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Luo, Wen-Lin (författare)
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Marti, AnaMaria (författare)
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Bernhardt, Peter (författare)
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Vincenti, Flavio (författare)
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- 2018
- 2018
- Engelska.
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Ingår i: Journal of the American Society of Nephrology. - 1046-6673 .- 1533-3450. ; 29:7, s. 1979-1991
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- Background Everolimus permits reduced calcineurin inhibitor (CNI) exposure, but the efficacy and safety outcomes of this treatment after kidney transplant require confirmation.Methods In a multicenter noninferiority trial, we randomized 2037 de novo kidney transplant recipients to receive, in combination with induction therapy and corticosteroids, everolimus with reduced-exposure CNI (everolimus arm) or mycophenolic acid (MPA) with standard-exposure CNI (MPA arm). The primary end point was treated biopsy-proven acute rejection or eGFR<50 ml/min per 1.73 m2 at post-transplant month 12 using a 10% noninferiority margin.Results In the intent-to-treat population (everolimus n=1022, MPA n=1015), the primary end point incidence was 48.2% (493) with everolimus and 45.1% (457) with MPA (difference 3.2%; 95% confidence interval, -1.3% to 7.6%). Similar between-treatment differences in incidence were observed in the subgroups of patients who received tacrolimus or cyclosporine. Treated biopsy-proven acute rejection, graft loss, or death at post-transplant month 12 occurred in 14.9% and 12.5% of patients treated with everolimus and MPA, respectively (difference 2.3%; 95% confidence interval, -1.7% to 6.4%). De novo donor-specific antibody incidence at 12 months and antibody-mediated rejection rate did not differ between arms. Cytomegalovirus (3.6% versus 13.3%) and BK virus infections (4.3% versus 8.0%) were less frequent in the everolimus arm than in the MPA arm. Overall, 23.0% and 11.9% of patients treated with everolimus and MPA, respectively, discontinued the study drug because of adverse events.Conclusions In kidney transplant recipients at mild-to-moderate immunologic risk, everolimus was noninferior to MPA for a binary composite end point assessing immunosuppressive efficacy and preservation of graft function.
Nyckelord
- calcineurin inhibitor
- efficacy graft
- everolimus
- function
- kidney transplantation
- randomized
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Pascual, Julio
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Berger, Stefan P
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Witzke, Oliver
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Tedesco, Helio
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Mulgaonkar, Sham ...
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Qazi, Yasir
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visa fler...
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Chadban, Steven
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Oppenheimer, Fed ...
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Sommerer, Claudi ...
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Oberbauer, Raine ...
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Watarai, Yoshihi ...
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Legendre, Christ ...
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Citterio, Franco
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Henry, Mitchell
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Srinivas, Titte ...
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Luo, Wen-Lin
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Marti, AnaMaria
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Bernhardt, Peter
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Vincenti, Flavio
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visa färre...
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Journal of the A ...
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Uppsala universitet