dc.contributor.author
Sommerer, Claudia
dc.contributor.author
Suwelack, Barbara
dc.contributor.author
Dragun, Duska
dc.contributor.author
Schenker, Peter
dc.contributor.author
Hauser, Ingeborg A.
dc.contributor.author
Nashan, Björn
dc.contributor.author
Thaiss, Friedrich
dc.date.accessioned
2018-06-08T02:59:01Z
dc.date.available
2016-03-23T13:08:40.551Z
dc.identifier.uri
https://refubium.fu-berlin.de/handle/fub188/14262
dc.identifier.uri
http://dx.doi.org/10.17169/refubium-18457
dc.description.abstract
Background Immunosuppression with calcineurin inhibitors remains the mainstay
of treatment after kidney transplantation; however, long-term use of these
drugs may be associated with nephrotoxicity. In this regard, the current
approach is to optimise available immunosuppressive regimens to reduce the
calcineurin inhibitor dose while protecting renal function without affecting
the efficacy. The ATHENA study is designed to evaluate renal function in two
regimens: an everolimus and reduced calcineurin inhibitor-based regimen versus
a standard treatment protocol with mycophenolic acid and tacrolimus in de novo
kidney transplant recipients. Method/Design ATHENA is a 12-month, multicentre,
open-label, prospective, randomised, parallel-group study in de novo kidney
transplant recipients (aged 18 years or older) receiving renal allografts from
deceased or living donors. Eligible patients are randomised (1:1:1) prior to
transplantation to one of the following three treatment arms: everolimus
(starting dose 1.5 mg/day; C0 3–8 ng/mL) with cyclosporine or everolimus
(starting dose 3 mg/day; C0 3–8 ng/mL) with tacrolimus or mycophenolic acid
(enteric-coated mycophenolate sodium at 1.44 g/day or mycophenolate mofetil at
2 g/day) with tacrolimus; in combination with corticosteroids. All patients
receive induction therapy with basiliximab. The primary objective is to
demonstrate non-inferiority of renal function (eGFR by the Nankivell formula)
in one of the everolimus arms compared with the standard group at month 12
post transplantation. The key secondary objective is to assess the incidence
of treatment failure, defined as biopsy-proven acute rejection, graft loss, or
death, among the treatment groups. Other objectives include assessment of the
individual components of treatment failure, incidence and severity of viral
infections, incidence and duration of delayed graft function, incidence of
indication biopsies, slow graft function and wound healing complications, and
overall safety and tolerability. Exploratory objectives include evaluation of
left ventricular hypertrophy assessed by the left ventricular mass index,
evolution of human leukocyte antigen and non-human leukocyte antigen
antibodies, and a cytomegalovirus substudy. Discussion As one of the largest
European multicentre kidney transplant studies, ATHENA will determine whether
a de novo everolimus-based regimen can preserve renal function versus the
standard of care. This study further assesses a number of clinical issues
which impact long-term outcomes post transplantation; hence, its results will
have a major clinical impact.
en
dc.rights.uri
http://creativecommons.org/licenses/by/4.0/
dc.subject
Renal function
dc.subject
Kidney transplantation
dc.subject.ddc
600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit
dc.title
Design and rationale of the ATHENA study – A 12-month, multicentre,
prospective study evaluating the outcomes of a de novo everolimus-based
regimen in combination with reduced cyclosporine or tacrolimus versus a
standard regimen in kidney transplant patients
dc.type
Wissenschaftlicher Artikel
dcterms.bibliographicCitation
Trials. - 17 (2016), Artikel Nr. 92
dc.title.subtitle
study protocol for a randomised controlled trial
dcterms.bibliographicCitation.doi
10.1186/s13063-016-1220-9
dcterms.bibliographicCitation.url
http://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1220-9
refubium.affiliation
Charité - Universitätsmedizin Berlin
de
refubium.mycore.fudocsId
FUDOCS_document_000000024228
refubium.note.author
Der Artikel wurde in einer Open-Access-Zeitschrift publiziert.
refubium.resourceType.isindependentpub
no
refubium.mycore.derivateId
FUDOCS_derivate_000000006179
dcterms.accessRights.openaire
open access