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 : 000E66 ( Istex/Corpus ); précédent : 000E65; suivant : 000E67Intravenous 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 ; Giulio Mingardi ; Johann Braun ; Pedro Aljama ; Peter G. Kerr ; Francesco Locatelli ; Giuseppe Villa ; Bruno Van Vlem ; Alan W. Mcmahon ; Ccile Kerloguen ; Ulrich BeyerSource :
- 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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<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title>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><mods:affiliation>Service de Nephrologie, Hpital Lapeyronie, Montpellier, France</mods:affiliation></affiliation></author><author><name sortKey="Mingardi, Giulio" sort="Mingardi, Giulio" uniqKey="Mingardi G" first="Giulio" last="Mingardi">Giulio Mingardi</name><affiliation><mods:affiliation>Unita Operativa di Nefrologia e Dialisi, Ospedali Riuniti di Bergamo, Bergamo, Italy</mods:affiliation></affiliation></author><author><name sortKey="Braun, Johann" sort="Braun, Johann" uniqKey="Braun J" first="Johann" last="Braun">Johann Braun</name><affiliation><mods:affiliation>KFH-Dialysezentrums, Nuernberg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Aljama, Pedro" sort="Aljama, Pedro" uniqKey="Aljama P" first="Pedro" last="Aljama">Pedro Aljama</name><affiliation><mods:affiliation>Hospital Reina Sofia, Servicio de Nefrologia, Cordoba, Spain</mods:affiliation></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><mods:affiliation>Department of Nephrology, Monash Medical Centre, Clayton, Australia</mods:affiliation></affiliation></author><author><name sortKey="Locatelli, Francesco" sort="Locatelli, Francesco" uniqKey="Locatelli F" first="Francesco" last="Locatelli">Francesco Locatelli</name><affiliation><mods:affiliation>Divisione di Nefrologia e Dialisi, Azienda Ospedale di Lecco, Lecco, Italy</mods:affiliation></affiliation></author><author><name sortKey="Villa, Giuseppe" sort="Villa, Giuseppe" uniqKey="Villa G" first="Giuseppe" last="Villa">Giuseppe Villa</name><affiliation><mods:affiliation>Divisione di Nefrologia e Dialisi, Fondazione S. Maugeri IRCCS, Pavia, Italy</mods:affiliation></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><mods:affiliation>Department of Nephrology, Dialysis and Hypertension, O.L. Vrouw Ziekenhuis, Aalst, Belgium</mods:affiliation></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><mods:affiliation>University of Alberta Hospital, Edmonton, Canada</mods:affiliation></affiliation></author><author><name sortKey="Kerloguen, Ccile" sort="Kerloguen, Ccile" uniqKey="Kerloguen C" first="Ccile" last="Kerloguen">Ccile Kerloguen</name><affiliation><mods:affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland</mods:affiliation></affiliation></author><author><name sortKey="Beyer, Ulrich" sort="Beyer, Ulrich" uniqKey="Beyer U" first="Ulrich" last="Beyer">Ulrich Beyer</name><affiliation><mods:affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland</mods:affiliation></affiliation></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></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><mods:affiliation>Service de Nephrologie, Hpital Lapeyronie, Montpellier, France</mods:affiliation></affiliation></author><author><name sortKey="Mingardi, Giulio" sort="Mingardi, Giulio" uniqKey="Mingardi G" first="Giulio" last="Mingardi">Giulio Mingardi</name><affiliation><mods:affiliation>Unita Operativa di Nefrologia e Dialisi, Ospedali Riuniti di Bergamo, Bergamo, Italy</mods:affiliation></affiliation></author><author><name sortKey="Braun, Johann" sort="Braun, Johann" uniqKey="Braun J" first="Johann" last="Braun">Johann Braun</name><affiliation><mods:affiliation>KFH-Dialysezentrums, Nuernberg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Aljama, Pedro" sort="Aljama, Pedro" uniqKey="Aljama P" first="Pedro" last="Aljama">Pedro Aljama</name><affiliation><mods:affiliation>Hospital Reina Sofia, Servicio de Nefrologia, Cordoba, Spain</mods:affiliation></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><mods:affiliation>Department of Nephrology, Monash Medical Centre, Clayton, Australia</mods:affiliation></affiliation></author><author><name sortKey="Locatelli, Francesco" sort="Locatelli, Francesco" uniqKey="Locatelli F" first="Francesco" last="Locatelli">Francesco Locatelli</name><affiliation><mods:affiliation>Divisione di Nefrologia e Dialisi, Azienda Ospedale di Lecco, Lecco, Italy</mods:affiliation></affiliation></author><author><name sortKey="Villa, Giuseppe" sort="Villa, Giuseppe" uniqKey="Villa G" first="Giuseppe" last="Villa">Giuseppe Villa</name><affiliation><mods:affiliation>Divisione di Nefrologia e Dialisi, Fondazione S. Maugeri IRCCS, Pavia, Italy</mods:affiliation></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><mods:affiliation>Department of Nephrology, Dialysis and Hypertension, O.L. Vrouw Ziekenhuis, Aalst, Belgium</mods:affiliation></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><mods:affiliation>University of Alberta Hospital, Edmonton, Canada</mods:affiliation></affiliation></author><author><name sortKey="Kerloguen, Ccile" sort="Kerloguen, Ccile" uniqKey="Kerloguen C" first="Ccile" last="Kerloguen">Ccile Kerloguen</name><affiliation><mods:affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland</mods:affiliation></affiliation></author><author><name sortKey="Beyer, Ulrich" sort="Beyer, Ulrich" uniqKey="Beyer U" first="Ulrich" last="Beyer">Ulrich Beyer</name><affiliation><mods:affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland</mods:affiliation></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><istex><corpusName>oup</corpusName><author><json:item><name>Bernard Canaud</name><affiliations><json:string>Service de Nephrologie, Hpital Lapeyronie, Montpellier, France</json:string></affiliations></json:item><json:item><name>Giulio Mingardi</name><affiliations><json:string>Unita Operativa di Nefrologia e Dialisi, Ospedali Riuniti di Bergamo, Bergamo, Italy</json:string></affiliations></json:item><json:item><name>Johann Braun</name><affiliations><json:string>KFH-Dialysezentrums, Nuernberg, Germany</json:string></affiliations></json:item><json:item><name>Pedro Aljama</name><affiliations><json:string>Hospital Reina Sofia, Servicio de Nefrologia, Cordoba, Spain</json:string></affiliations></json:item><json:item><name>Peter G. Kerr</name><affiliations><json:string>Department of Nephrology, Monash Medical Centre, Clayton, Australia</json:string></affiliations></json:item><json:item><name>Francesco Locatelli</name><affiliations><json:string>Divisione di Nefrologia e Dialisi, Azienda Ospedale di Lecco, Lecco, Italy</json:string></affiliations></json:item><json:item><name>Giuseppe Villa</name><affiliations><json:string>Divisione di Nefrologia e Dialisi, Fondazione S. Maugeri IRCCS, Pavia, Italy</json:string></affiliations></json:item><json:item><name>Bruno Van Vlem</name><affiliations><json:string>Department of Nephrology, Dialysis and Hypertension, O.L. Vrouw Ziekenhuis, Aalst, Belgium</json:string></affiliations></json:item><json:item><name>Alan W. McMahon</name><affiliations><json:string>University of Alberta Hospital, Edmonton, Canada</json:string></affiliations></json:item><json:item><name>Ccile Kerloguen</name><affiliations><json:string>F. Hoffmann-La Roche Ltd, Basel, Switzerland</json:string></affiliations></json:item><json:item><name>Ulrich Beyer</name><affiliations><json:string>F. Hoffmann-La Roche Ltd, Basel, Switzerland</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>anaemia</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>C.E.R.A.</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>darbepoetin alfa</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>dialysis</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>haemoglobin</value></json:item></subject><articleId><json:string>gfn320</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>research-article</json:string></originalGenre><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.</abstract><qualityIndicators><score>8</score><pdfVersion>1.2</pdfVersion><pdfPageSize>612 x 792 pts (letter)</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>5</keywordCount><abstractCharCount>1897</abstractCharCount><pdfWordCount>5467</pdfWordCount><pdfCharCount>35835</pdfCharCount><pdfPageCount>8</pdfPageCount><abstractWordCount>271</abstractWordCount></qualityIndicators><title>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><corporate><json:item><name>on behalf of the STRIATA Study Investigators</name></json:item></corporate><genre><json:string>research-article</json:string></genre><host><volume>23</volume><publisherId><json:string>ndt</json:string></publisherId><pages><last>3661</last><first>3654</first></pages><issn><json:string>0931-0509</json:string></issn><issue>11</issue><genre><json:string>journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1460-2385</json:string></eissn><title>Nephrology Dialysis Transplantation</title></host><categories><wos><json:string>TRANSPLANTATION</json:string><json:string>UROLOGY & NEPHROLOGY</json:string></wos></categories><publicationDate>2008</publicationDate><copyrightDate>2008</copyrightDate><doi><json:string>10.1093/ndt/gfn320</json:string></doi><id>7AA7D35129A89E6118705AE72CD910431C8EB272</id><score>0.2492126</score><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/7AA7D35129A89E6118705AE72CD910431C8EB272/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/7AA7D35129A89E6118705AE72CD910431C8EB272/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/7AA7D35129A89E6118705AE72CD910431C8EB272/fulltext/tei"><teiHeader><fileDesc><titleStmt><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></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Oxford University Press</publisher><availability><p>The Author [2008].</p></availability><date>2008-06-27</date></publicationStmt><notesStmt><note>STRIATA is registered at www.clinicaltrials.gov (reference NCT00077766). The list of STRIATA Study Investigators is given in the Appendix.</note></notesStmt><sourceDesc><biblStruct type="inbook"><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><orgName>on behalf of the STRIATA Study Investigators</orgName></author><author xml:id="author-2"><persName><forename type="first">Bernard</forename><surname>Canaud</surname></persName><affiliation>Service de Nephrologie, Hpital Lapeyronie, Montpellier, France</affiliation></author><author xml:id="author-3"><persName><forename type="first">Giulio</forename><surname>Mingardi</surname></persName><affiliation>Unita Operativa di Nefrologia e Dialisi, Ospedali Riuniti di Bergamo, Bergamo, Italy</affiliation></author><author xml:id="author-4"><persName><forename type="first">Johann</forename><surname>Braun</surname></persName><affiliation>KFH-Dialysezentrums, Nuernberg, Germany</affiliation></author><author xml:id="author-5"><persName><forename type="first">Pedro</forename><surname>Aljama</surname></persName><affiliation>Hospital Reina Sofia, Servicio de Nefrologia, Cordoba, Spain</affiliation></author><author xml:id="author-6"><persName><forename type="first">Peter G.</forename><surname>Kerr</surname></persName><affiliation>Department of Nephrology, Monash Medical Centre, Clayton, Australia</affiliation></author><author xml:id="author-7"><persName><forename type="first">Francesco</forename><surname>Locatelli</surname></persName><affiliation>Divisione di Nefrologia e Dialisi, Azienda Ospedale di Lecco, Lecco, Italy</affiliation></author><author xml:id="author-8"><persName><forename type="first">Giuseppe</forename><surname>Villa</surname></persName><affiliation>Divisione di Nefrologia e Dialisi, Fondazione S. Maugeri IRCCS, Pavia, Italy</affiliation></author><author xml:id="author-9"><persName><forename type="first">Bruno</forename><surname>Van Vlem</surname></persName><affiliation>Department of Nephrology, Dialysis and Hypertension, O.L. Vrouw Ziekenhuis, Aalst, Belgium</affiliation></author><author xml:id="author-10"><persName><forename type="first">Alan W.</forename><surname>McMahon</surname></persName><affiliation>University of Alberta Hospital, Edmonton, Canada</affiliation></author><author xml:id="author-11"><persName><forename type="first">Ccile</forename><surname>Kerloguen</surname></persName><affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland</affiliation></author><author xml:id="author-12"><persName><forename type="first">Ulrich</forename><surname>Beyer</surname></persName><affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland</affiliation></author></analytic><monogr><title level="j">Nephrology Dialysis Transplantation</title><title level="j" type="abbrev">Nephrol Dial Transplant</title><idno type="pISSN">0931-0509</idno><idno type="eISSN">1460-2385</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="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></monogr><idno type="istex">7AA7D35129A89E6118705AE72CD910431C8EB272</idno><idno type="DOI">10.1093/ndt/gfn320</idno><idno type="ArticleID">gfn320</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2008-06-27</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>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.</p></abstract><textClass><keywords scheme="keyword"><list><head>Keywords</head><item><term>anaemia</term></item><item><term>C.E.R.A.</term></item><item><term>darbepoetin alfa</term></item><item><term>dialysis</term></item><item><term>haemoglobin</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2008-06-27">Created</change><change when="2008-11">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/7AA7D35129A89E6118705AE72CD910431C8EB272/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus oup" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="utf-8"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Publishing DTD v2.3 20070202//EN" URI="journalpublishing.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="research-article"><front><journal-meta><journal-id journal-id-type="publisher-id">ndt</journal-id><journal-id journal-id-type="hwp">ndt</journal-id><journal-title>Nephrology Dialysis Transplantation</journal-title><abbrev-journal-title abbrev-type="pubmed">Nephrol Dial Transplant</abbrev-journal-title><issn pub-type="ppub">0931-0509</issn><issn pub-type="epub">1460-2385</issn><publisher><publisher-name>Oxford University Press</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.1093/ndt/gfn320</article-id><article-id pub-id-type="publisher-id">gfn320</article-id><article-categories><subj-group subj-group-type="heading"><subject>Dialysis</subject></subj-group></article-categories><title-group><article-title>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</article-title><alt-title alt-title-type="left-running">B. Canaud <italic>et al</italic>.</alt-title><alt-title alt-title-type="right-running">STRIATA haemoglobin maintenance in patients on dialysis</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Canaud</surname><given-names>Bernard</given-names></name><xref ref-type="aff" rid="af1">1</xref></contrib><contrib contrib-type="author"><name><surname>Mingardi</surname><given-names>Giulio</given-names></name><xref ref-type="aff" rid="af2">2</xref></contrib><contrib contrib-type="author"><name><surname>Braun</surname><given-names>Johann</given-names></name><xref ref-type="aff" rid="af3">3</xref></contrib><contrib contrib-type="author"><name><surname>Aljama</surname><given-names>Pedro</given-names></name><xref ref-type="aff" rid="af4">4</xref></contrib><contrib contrib-type="author"><name><surname>Kerr</surname><given-names>Peter G.</given-names></name><xref ref-type="aff" rid="af5">5</xref></contrib><contrib contrib-type="author"><name><surname>Locatelli</surname><given-names>Francesco</given-names></name><xref ref-type="aff" rid="af6">6</xref></contrib><contrib contrib-type="author"><name><surname>Villa</surname><given-names>Giuseppe</given-names></name><xref ref-type="aff" rid="af7">7</xref></contrib><contrib contrib-type="author"><name><surname>Van Vlem</surname><given-names>Bruno</given-names></name><xref ref-type="aff" rid="af8">8</xref></contrib><contrib contrib-type="author"><name><surname>McMahon</surname><given-names>Alan W.</given-names></name><xref ref-type="aff" rid="af9">9</xref></contrib><contrib contrib-type="author"><name><surname>Kerloëguen</surname><given-names>Cécile</given-names></name><xref ref-type="aff" rid="af10">10</xref></contrib><contrib contrib-type="author"><name><surname>Beyer</surname><given-names>Ulrich</given-names></name><xref ref-type="aff" rid="af10">10</xref></contrib><contrib contrib-type="author"><collab>on behalf of the STRIATA Study Investigators</collab><xref ref-type="author-notes" rid="AFN1">*</xref></contrib></contrib-group><aff id="af1"><label>1</label><addr-line>Service de Nephrologie</addr-line>, <institution>Hôpital Lapeyronie</institution>, <addr-line>Montpellier</addr-line>, <country>France</country></aff><aff id="af2"><label>2</label><addr-line>Unita’ Operativa di Nefrologia e Dialisi</addr-line>, <institution>Ospedali Riuniti di Bergamo</institution>, <addr-line>Bergamo</addr-line>, <country>Italy</country></aff><aff id="af3"><label>3</label><addr-line>KFH-Dialysezentrums, Nuernberg</addr-line>, <country>Germany</country></aff><aff id="af4"><label>4</label><addr-line>Hospital Reina Sofia</addr-line>, <institution>Servicio de Nefrologia</institution>, <addr-line>Cordoba</addr-line>, <country>Spain</country></aff><aff id="af5"><label>5</label><addr-line>Department of Nephrology</addr-line>, <institution>Monash Medical Centre</institution>, <addr-line>Clayton</addr-line>, <country>Australia</country></aff><aff id="af6"><label>6</label><addr-line>Divisione di Nefrologia e Dialisi</addr-line>, <institution>Azienda Ospedale di Lecco</institution>, <addr-line>Lecco</addr-line>, <country>Italy</country></aff><aff id="af7"><label>7</label><addr-line>Divisione di Nefrologia e Dialisi</addr-line>, <institution>Fondazione ‘S. Maugeri’ IRCCS</institution>, <addr-line>Pavia</addr-line>, <country>Italy</country></aff><aff id="af8"><label>8</label><addr-line>Department of Nephrology</addr-line>, <institution>Dialysis and Hypertension</institution>, <addr-line>O.L. Vrouw Ziekenhuis, Aalst</addr-line>, <country>Belgium</country></aff><aff id="af9"><label>9</label><institution>University of Alberta Hospital</institution>, <addr-line>Edmonton</addr-line>, <country>Canada</country></aff><aff id="af10"><label>10</label><institution>F. Hoffmann-La Roche Ltd</institution>, <addr-line>Basel</addr-line>, <country>Switzerland</country></aff><author-notes><corresp><italic>Correspondence and offprint requests to</italic>: Bernard Canaud, Hôpital Lapeyronie, Service de Nephrologie, 317 av. Du Doyen Gaston Giraud, F-34295, Montpellier, France. Tel: <phone>+33-4-6733-8479</phone>; Fax: <fax>+33-4-6760-3783</fax>; E-mail: <email>b-canaud@chu-montpellier.fr</email></corresp><fn id="AFN1"><label>*</label><p>STRIATA is registered at www.clinicaltrials.gov (reference NCT00077766). The list of STRIATA Study Investigators is given in the Appendix.</p></fn></author-notes><pub-date pub-type="ppub"><month>11</month><year>2008</year></pub-date><pub-date pub-type="epub"><day>27</day><month>6</month><year>2008</year></pub-date><volume>23</volume><issue>11</issue><fpage>3654</fpage><lpage>3661</lpage><history><date date-type="received"><day>19</day><month>9</month><year>2007</year></date><date date-type="accepted"><day>19</day><month>5</month><year>2008</year></date></history><permissions><copyright-statement>© The Author [2008].</copyright-statement><copyright-year>2008</copyright-year><copyright-holder>Oxford University Press</copyright-holder><license license-type="creative-commons" xlink:href="http://creativecommons.org/licenses/by-nc/2.0/uk/"><p>The online version of this article has been published under an open access model. Users are entitled to use, reproduce, disseminate, or display the open access version of this article for non-commercial purposes provided that: the original authorship is properly and fully attributed; the Journal and Oxford University Press are attributed as the original place of publication with the correct citation details given; if an article is subsequently reproduced or disseminated not in its entirety but only in part or as a derivative work this must be clearly indicated. For commercial re-use, please contact journals.permissions@oxfordjournals.org</p></license></permissions><abstract><p><bold>Background.</bold> 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.</p><p><bold>Methods.</bold> 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 (<italic>n</italic> = 156) or receive intravenous C.E.R.A. Q2W (<italic>n</italic> = 157) for 52 weeks. Doses were adjusted to maintain Hb levels within ± 1.0 g/dl of baseline and between 10.0 and 13.5 g/dl. The primary endpoint was the mean Hb change between baseline and the evaluation period (weeks 29–36).</p><p><bold>Results.</bold> 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 g/dl (−0.05, 0.41), within a pre-defined non-inferiority limit. C.E.R.A. was clinically non-inferior to DA (<italic>P</italic> < 0.0001) in maintaining Hb levels. Both treatments were well tolerated.</p><p><bold>Conclusions.</bold> Stable Hb levels were successfully maintained in patients on haemodialysis directly converted to Q2W intravenous C.E.R.A. from DA.</p></abstract><kwd-group><title>Keywords</title><kwd>anaemia</kwd><kwd>C.E.R.A.</kwd><kwd>darbepoetin alfa</kwd><kwd>dialysis</kwd><kwd>haemoglobin</kwd></kwd-group></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo><title>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></titleInfo><titleInfo type="alternative" contentType="CDATA"><title>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></titleInfo><name type="corporate"><namePart>on behalf of the STRIATA Study Investigators</namePart></name><name type="personal"><namePart type="given">Bernard</namePart><namePart type="family">Canaud</namePart><affiliation>Service de Nephrologie, Hpital Lapeyronie, Montpellier, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Giulio</namePart><namePart type="family">Mingardi</namePart><affiliation>Unita Operativa di Nefrologia e Dialisi, Ospedali Riuniti di Bergamo, Bergamo, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Johann</namePart><namePart type="family">Braun</namePart><affiliation>KFH-Dialysezentrums, Nuernberg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Pedro</namePart><namePart type="family">Aljama</namePart><affiliation>Hospital Reina Sofia, Servicio de Nefrologia, Cordoba, Spain</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Peter G.</namePart><namePart type="family">Kerr</namePart><affiliation>Department of Nephrology, Monash Medical Centre, Clayton, Australia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Francesco</namePart><namePart type="family">Locatelli</namePart><affiliation>Divisione di Nefrologia e Dialisi, Azienda Ospedale di Lecco, Lecco, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Giuseppe</namePart><namePart type="family">Villa</namePart><affiliation>Divisione di Nefrologia e Dialisi, Fondazione S. Maugeri IRCCS, Pavia, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Bruno</namePart><namePart type="family">Van Vlem</namePart><affiliation>Department of Nephrology, Dialysis and Hypertension, O.L. Vrouw Ziekenhuis, Aalst, Belgium</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Alan W.</namePart><namePart type="family">McMahon</namePart><affiliation>University of Alberta Hospital, Edmonton, Canada</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Ccile</namePart><namePart type="family">Kerloguen</namePart><affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Ulrich</namePart><namePart type="family">Beyer</namePart><affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article"></genre><originInfo><publisher>Oxford University Press</publisher><dateIssued encoding="w3cdtf">2008-11</dateIssued><dateCreated encoding="w3cdtf">2008-06-27</dateCreated><copyrightDate encoding="w3cdtf">2008</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><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.</abstract><note type="footnotes">STRIATA is registered at www.clinicaltrials.gov (reference NCT00077766). The list of STRIATA Study Investigators is given in the Appendix.</note><subject><genre>Keywords</genre><topic>anaemia</topic><topic>C.E.R.A.</topic><topic>darbepoetin alfa</topic><topic>dialysis</topic><topic>haemoglobin</topic></subject><relatedItem type="host"><titleInfo><title>Nephrology Dialysis Transplantation</title></titleInfo><titleInfo type="abbreviated"><title>Nephrol Dial Transplant</title></titleInfo><genre type="journal">journal</genre><identifier type="ISSN">0931-0509</identifier><identifier type="eISSN">1460-2385</identifier><identifier type="PublisherID">ndt</identifier><identifier type="PublisherID-hwp">ndt</identifier><part><date>2008</date><detail type="volume"><caption>vol.</caption><number>23</number></detail><detail type="issue"><caption>no.</caption><number>11</number></detail><extent unit="pages"><start>3654</start><end>3661</end></extent></part></relatedItem><identifier type="istex">7AA7D35129A89E6118705AE72CD910431C8EB272</identifier><identifier type="DOI">10.1093/ndt/gfn320</identifier><identifier type="ArticleID">gfn320</identifier><accessCondition type="use and reproduction" contentType="copyright">The Author [2008].</accessCondition><recordInfo><recordContentSource>OUP</recordContentSource><recordOrigin>Oxford University Press</recordOrigin></recordInfo></mods></metadata><covers><json:item><original>true</original><mimetype>image/tiff</mimetype><extension>tiff</extension><uri>https://api.istex.fr/document/7AA7D35129A89E6118705AE72CD910431C8EB272/covers/tiff</uri></json:item></covers><annexes><json:item><original>true</original><mimetype>image/jpeg</mimetype><extension>jpeg</extension><uri>https://api.istex.fr/document/7AA7D35129A89E6118705AE72CD910431C8EB272/annexes/jpeg</uri></json:item><json:item><original>true</original><mimetype>image/gif</mimetype><extension>gif</extension><uri>https://api.istex.fr/document/7AA7D35129A89E6118705AE72CD910431C8EB272/annexes/gif</uri></json:item><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/7AA7D35129A89E6118705AE72CD910431C8EB272/annexes/pdf</uri></json:item></annexes><enrichments><istex:catWosTEI uri="https://api.istex.fr/document/7AA7D35129A89E6118705AE72CD910431C8EB272/enrichments/catWos"><teiHeader><profileDesc><textClass><classCode scheme="WOS">TRANSPLANTATION</classCode><classCode scheme="WOS">UROLOGY & NEPHROLOGY</classCode></textClass></profileDesc></teiHeader></istex:catWosTEI></enrichments><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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