Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study
Identifieur interne : 000142 ( France/Analysis ); précédent : 000141; suivant : 000143Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study
Auteurs : Bernard Canaud [France] ; Giulio Mingardi [Italie] ; Johann Braun [Allemagne] ; Pedro Aljama [Espagne] ; Peter G. Kerr [Australie] ; Francesco Locatelli [Italie] ; Giuseppe Villa [Italie] ; Bruno Van Vlem [Belgique] ; Alan W. Mcmahon [Canada] ; Ccile Kerloguen [Suisse] ; Ulrich Beyer [Suisse]Source :
- Nephrology Dialysis Transplantation [ 0931-0509 ] ; 2008-11.
Abstract
Background. Extending the administration interval of erythropoiesis-stimulating agents (ESAs) represents an opportunity to improve the efficiency of anaemia management in patients with chronic kidney disease (CKD). However, effective haemoglobin (Hb) maintenance can be challenging with epoetin alfa and epoetin beta administered at extended intervals. C.E.R.A., a continuous erythropoietin receptor activator, has a unique pharmacologic profile and long half-life (130 h), allowing administration at extended intervals. Phase III results have demonstrated that C.E.R.A. administered once every 4 weeks effectively maintains stable Hb levels in patients with CKD on dialysis. Methods. STRIATA (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. Treatment for Anaemia) was a multicentre, open-label randomized phase III study to evaluate the efficacy and safety of intravenous C.E.R.A. administered once every 2 weeks (Q2W) for Hb maintenance following direct conversion from darbepoetin alfa (DA). Adult patients on dialysis receiving stable intravenous DA once weekly (QW) or Q2W were randomized (1:1) to continue their current DA regimen (n 156) or receive intravenous C.E.R.A. Q2W (n 157) for 52 weeks. Doses were adjusted to maintain Hb levels within 1.0 gdl of baseline and between 10.0 and 13.5 gdl. The primary endpoint was the mean Hb change between baseline and the evaluation period (weeks 2936). Results. Most patients (>80) received DA QW before randomization. The mean (95 CI) difference between C.E.R.A. and DA in the primary endpoint was 0.18 gdl (0.05, 0.41), within a pre-defined non-inferiority limit. C.E.R.A. was clinically non-inferior to DA (P < 0.0001) in maintaining Hb levels. Both treatments were well tolerated. Conclusions. Stable Hb levels were successfully maintained in patients on haemodialysis directly converted to Q2W intravenous C.E.R.A. from DA.
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DOI: 10.1093/ndt/gfn320
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Kerr</name></author><author><name sortKey="Locatelli, Francesco" sort="Locatelli, Francesco" uniqKey="Locatelli F" first="Francesco" last="Locatelli">Francesco Locatelli</name></author><author><name sortKey="Villa, Giuseppe" sort="Villa, Giuseppe" uniqKey="Villa G" first="Giuseppe" last="Villa">Giuseppe Villa</name></author><author><name sortKey="Van Vlem, Bruno" sort="Van Vlem, Bruno" uniqKey="Van Vlem B" first="Bruno" last="Van Vlem">Bruno Van Vlem</name></author><author><name sortKey="Mcmahon, Alan W" sort="Mcmahon, Alan W" uniqKey="Mcmahon A" first="Alan W." last="Mcmahon">Alan W. Mcmahon</name></author><author><name sortKey="Kerloguen, Ccile" sort="Kerloguen, Ccile" uniqKey="Kerloguen C" first="Ccile" last="Kerloguen">Ccile Kerloguen</name></author><author><name sortKey="Beyer, Ulrich" sort="Beyer, Ulrich" uniqKey="Beyer U" first="Ulrich" last="Beyer">Ulrich Beyer</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:7AA7D35129A89E6118705AE72CD910431C8EB272</idno><date when="2008" year="2008">2008</date><idno type="doi">10.1093/ndt/gfn320</idno><idno type="url">https://api.istex.fr/document/7AA7D35129A89E6118705AE72CD910431C8EB272/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000E66</idno><idno type="wicri:Area/Istex/Curation">000E57</idno><idno type="wicri:Area/Istex/Checkpoint">000E03</idno><idno type="wicri:doubleKey">0931-0509:2008:Canaud B:intravenous:c:e</idno><idno type="wicri:Area/Main/Merge">001320</idno><idno type="wicri:Area/Main/Curation">001317</idno><idno type="wicri:Area/Main/Exploration">001317</idno><idno type="wicri:Area/France/Extraction">000142</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a">Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study</title><author><name sortKey="Canaud, Bernard" sort="Canaud, Bernard" uniqKey="Canaud B" first="Bernard" last="Canaud">Bernard Canaud</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Service de Nephrologie, Hpital Lapeyronie, Montpellier</wicri:regionArea><placeName><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Mingardi, Giulio" sort="Mingardi, Giulio" uniqKey="Mingardi G" first="Giulio" last="Mingardi">Giulio Mingardi</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>Unita Operativa di Nefrologia e Dialisi, Ospedali Riuniti di Bergamo, Bergamo</wicri:regionArea><wicri:noRegion>Bergamo</wicri:noRegion></affiliation></author><author><name sortKey="Braun, Johann" sort="Braun, Johann" uniqKey="Braun J" first="Johann" last="Braun">Johann Braun</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>KFH-Dialysezentrums, Nuernberg</wicri:regionArea><wicri:noRegion>Nuernberg</wicri:noRegion><wicri:noRegion>Nuernberg</wicri:noRegion></affiliation></author><author><name sortKey="Aljama, Pedro" sort="Aljama, Pedro" uniqKey="Aljama P" first="Pedro" last="Aljama">Pedro Aljama</name><affiliation wicri:level="1"><country xml:lang="fr">Espagne</country><wicri:regionArea>Hospital Reina Sofia, Servicio de Nefrologia, Cordoba</wicri:regionArea><wicri:noRegion>Cordoba</wicri:noRegion></affiliation></author><author><name sortKey="Kerr, Peter G" sort="Kerr, Peter G" uniqKey="Kerr P" first="Peter G." last="Kerr">Peter G. Kerr</name><affiliation wicri:level="1"><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Nephrology, Monash Medical Centre, Clayton</wicri:regionArea><wicri:noRegion>Clayton</wicri:noRegion></affiliation></author><author><name sortKey="Locatelli, Francesco" sort="Locatelli, Francesco" uniqKey="Locatelli F" first="Francesco" last="Locatelli">Francesco Locatelli</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>Divisione di Nefrologia e Dialisi, Azienda Ospedale di Lecco, Lecco</wicri:regionArea><wicri:noRegion>Lecco</wicri:noRegion></affiliation></author><author><name sortKey="Villa, Giuseppe" sort="Villa, Giuseppe" uniqKey="Villa G" first="Giuseppe" last="Villa">Giuseppe Villa</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>Divisione di Nefrologia e Dialisi, Fondazione S. Maugeri IRCCS, Pavia</wicri:regionArea><wicri:noRegion>Pavia</wicri:noRegion></affiliation></author><author><name sortKey="Van Vlem, Bruno" sort="Van Vlem, Bruno" uniqKey="Van Vlem B" first="Bruno" last="Van Vlem">Bruno Van Vlem</name><affiliation wicri:level="1"><country xml:lang="fr">Belgique</country><wicri:regionArea>Department of Nephrology, Dialysis and Hypertension, O.L. Vrouw Ziekenhuis, Aalst</wicri:regionArea><wicri:noRegion>Aalst</wicri:noRegion></affiliation></author><author><name sortKey="Mcmahon, Alan W" sort="Mcmahon, Alan W" uniqKey="Mcmahon A" first="Alan W." last="Mcmahon">Alan W. Mcmahon</name><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>University of Alberta Hospital, Edmonton</wicri:regionArea><wicri:noRegion>Edmonton</wicri:noRegion></affiliation></author><author><name sortKey="Kerloguen, Ccile" sort="Kerloguen, Ccile" uniqKey="Kerloguen C" first="Ccile" last="Kerloguen">Ccile Kerloguen</name><affiliation wicri:level="1"><country xml:lang="fr">Suisse</country><wicri:regionArea>F. Hoffmann-La Roche Ltd, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation></author><author><name sortKey="Beyer, Ulrich" sort="Beyer, Ulrich" uniqKey="Beyer U" first="Ulrich" last="Beyer">Ulrich Beyer</name><affiliation wicri:level="1"><country xml:lang="fr">Suisse</country><wicri:regionArea>F. Hoffmann-La Roche Ltd, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j">Nephrology Dialysis Transplantation</title><title level="j" type="abbrev">Nephrol Dial Transplant</title><idno type="ISSN">0931-0509</idno><idno type="eISSN">1460-2385</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2008-11">2008-11</date><biblScope unit="volume">23</biblScope><biblScope unit="issue">11</biblScope><biblScope unit="page" from="3654">3654</biblScope><biblScope unit="page" to="3661">3661</biblScope></imprint><idno type="ISSN">0931-0509</idno></series><idno type="istex">7AA7D35129A89E6118705AE72CD910431C8EB272</idno><idno type="DOI">10.1093/ndt/gfn320</idno><idno type="ArticleID">gfn320</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0931-0509</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Background. Extending the administration interval of erythropoiesis-stimulating agents (ESAs) represents an opportunity to improve the efficiency of anaemia management in patients with chronic kidney disease (CKD). However, effective haemoglobin (Hb) maintenance can be challenging with epoetin alfa and epoetin beta administered at extended intervals. C.E.R.A., a continuous erythropoietin receptor activator, has a unique pharmacologic profile and long half-life (130 h), allowing administration at extended intervals. Phase III results have demonstrated that C.E.R.A. administered once every 4 weeks effectively maintains stable Hb levels in patients with CKD on dialysis. Methods. STRIATA (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. Treatment for Anaemia) was a multicentre, open-label randomized phase III study to evaluate the efficacy and safety of intravenous C.E.R.A. administered once every 2 weeks (Q2W) for Hb maintenance following direct conversion from darbepoetin alfa (DA). Adult patients on dialysis receiving stable intravenous DA once weekly (QW) or Q2W were randomized (1:1) to continue their current DA regimen (n 156) or receive intravenous C.E.R.A. Q2W (n 157) for 52 weeks. Doses were adjusted to maintain Hb levels within 1.0 gdl of baseline and between 10.0 and 13.5 gdl. The primary endpoint was the mean Hb change between baseline and the evaluation period (weeks 2936). Results. Most patients (>80) received DA QW before randomization. The mean (95 CI) difference between C.E.R.A. and DA in the primary endpoint was 0.18 gdl (0.05, 0.41), within a pre-defined non-inferiority limit. C.E.R.A. was clinically non-inferior to DA (P < 0.0001) in maintaining Hb levels. Both treatments were well tolerated. Conclusions. Stable Hb levels were successfully maintained in patients on haemodialysis directly converted to Q2W intravenous C.E.R.A. from DA.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Belgique</li><li>Canada</li><li>Espagne</li><li>France</li><li>Italie</li><li>Suisse</li></country><settlement><li>Montpellier</li></settlement></list><tree><country name="France"><noRegion><name sortKey="Canaud, Bernard" sort="Canaud, Bernard" uniqKey="Canaud B" first="Bernard" last="Canaud">Bernard Canaud</name></noRegion></country><country name="Italie"><noRegion><name sortKey="Mingardi, Giulio" sort="Mingardi, Giulio" uniqKey="Mingardi G" first="Giulio" last="Mingardi">Giulio Mingardi</name></noRegion><name sortKey="Locatelli, Francesco" sort="Locatelli, Francesco" uniqKey="Locatelli F" first="Francesco" last="Locatelli">Francesco Locatelli</name><name sortKey="Villa, Giuseppe" sort="Villa, Giuseppe" uniqKey="Villa G" first="Giuseppe" last="Villa">Giuseppe Villa</name></country><country name="Allemagne"><noRegion><name sortKey="Braun, Johann" sort="Braun, Johann" uniqKey="Braun J" first="Johann" last="Braun">Johann Braun</name></noRegion></country><country name="Espagne"><noRegion><name sortKey="Aljama, Pedro" sort="Aljama, Pedro" uniqKey="Aljama P" first="Pedro" last="Aljama">Pedro Aljama</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Kerr, Peter G" sort="Kerr, Peter G" uniqKey="Kerr P" first="Peter G." last="Kerr">Peter G. Kerr</name></noRegion></country><country name="Belgique"><noRegion><name sortKey="Van Vlem, Bruno" sort="Van Vlem, Bruno" uniqKey="Van Vlem B" first="Bruno" last="Van Vlem">Bruno Van Vlem</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Mcmahon, Alan W" sort="Mcmahon, Alan W" uniqKey="Mcmahon A" first="Alan W." last="Mcmahon">Alan W. Mcmahon</name></noRegion></country><country name="Suisse"><noRegion><name sortKey="Kerloguen, Ccile" sort="Kerloguen, Ccile" uniqKey="Kerloguen C" first="Ccile" last="Kerloguen">Ccile Kerloguen</name></noRegion><name sortKey="Beyer, Ulrich" sort="Beyer, Ulrich" uniqKey="Beyer U" first="Ulrich" last="Beyer">Ulrich Beyer</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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