Search: onr:"swepub:oai:DiVA.org:uu-397512" >
Everolimus with Red...
Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation.
-
Pascual, Julio (author)
-
Berger, Stefan P (author)
-
Witzke, Oliver (author)
-
show more...
-
Tedesco, Helio (author)
-
Mulgaonkar, Shamkant (author)
-
Qazi, Yasir (author)
-
Chadban, Steven (author)
-
Oppenheimer, Federico (author)
-
Sommerer, Claudia (author)
-
Oberbauer, Rainer (author)
-
Watarai, Yoshihiko (author)
-
Legendre, Christophe (author)
-
Citterio, Franco (author)
-
Henry, Mitchell (author)
-
Srinivas, Titte R (author)
-
Luo, Wen-Lin (author)
-
Marti, AnaMaria (author)
-
Bernhardt, Peter (author)
-
Vincenti, Flavio (author)
-
show less...
- 2018
- 2018
- English.
-
In: Journal of the American Society of Nephrology. - 1046-6673 .- 1533-3450. ; 29:7, s. 1979-1991
- Related links:
-
https://urn.kb.se/re...
-
show more...
-
https://doi.org/10.1...
-
show less...
Abstract
Subject headings
Close
- 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.
Keyword
- calcineurin inhibitor
- efficacy graft
- everolimus
- function
- kidney transplantation
- randomized
Publication and Content Type
- ref (subject category)
- art (subject category)
Find in a library
To the university's database
- By the author/editor
-
Pascual, Julio
-
Berger, Stefan P
-
Witzke, Oliver
-
Tedesco, Helio
-
Mulgaonkar, Sham ...
-
Qazi, Yasir
-
show more...
-
Chadban, Steven
-
Oppenheimer, Fed ...
-
Sommerer, Claudi ...
-
Oberbauer, Raine ...
-
Watarai, Yoshihi ...
-
Legendre, Christ ...
-
Citterio, Franco
-
Henry, Mitchell
-
Srinivas, Titte ...
-
Luo, Wen-Lin
-
Marti, AnaMaria
-
Bernhardt, Peter
-
Vincenti, Flavio
-
show less...
- Articles in the publication
-
Journal of the A ...
- By the university
-
Uppsala University