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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<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>
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<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>
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<notesStmt><note>STRIATA is registered at www.clinicaltrials.gov (reference NCT00077766). The list of STRIATA Study Investigators is given in the Appendix.</note>
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<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>
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<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>
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<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>
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<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>
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<name type="personal"><namePart type="given">Bernard</namePart>
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<name type="personal"><namePart type="given">Pedro</namePart>
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<name type="personal"><namePart type="given">Peter G.</namePart>
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<name type="personal"><namePart type="given">Francesco</namePart>
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<name type="personal"><namePart type="given">Giuseppe</namePart>
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<name type="personal"><namePart type="given">Bruno</namePart>
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<name type="personal"><namePart type="given">Alan W.</namePart>
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<role><roleTerm type="text">author</roleTerm>
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<name type="personal"><namePart type="given">Ccile</namePart>
<namePart type="family">Kerloguen</namePart>
<affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland</affiliation>
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<name type="personal"><namePart type="given">Ulrich</namePart>
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<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>
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