Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials
Identifieur interne : 001A20 ( Main/Exploration ); précédent : 001A19; suivant : 001A21Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials
Auteurs : Francesco Locatelli [Italie] ; Gabriel Choukroun [France] ; Matt Truman [Australie] ; Alfons Wiggenhauser [Allemagne] ; Danilo Fliser [Allemagne]Source :
- Advances in Therapy [ 0741-238X ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen, Antianémiques (pharmacologie), Anémie (diagnostic), Anémie (traitement médicamenteux), Anémie (étiologie), Dialyse rénale (), Dialyse rénale (effets indésirables), Essais cliniques de phase III comme sujet, Essais contrôlés randomisés comme sujet, Femelle, Humains, Hémoglobines (analyse), Insuffisance rénale chronique (), Mâle, Polyéthylène glycols (pharmacologie), Relation dose-effet des médicaments, Statistiques comme sujet, Sujet âgé, Érythropoïétine (pharmacologie), Évaluation des résultats et des processus en soins de santé.
- MESH :
- analyse : Hémoglobines.
- diagnostic : Anémie.
- effets indésirables : Dialyse rénale.
- pharmacologie : Antianémiques, Polyéthylène glycols, Érythropoïétine.
- traitement médicamenteux : Anémie.
- étiologie : Anémie.
- Adulte d'âge moyen, Dialyse rénale, Essais cliniques de phase III comme sujet, Essais contrôlés randomisés comme sujet, Femelle, Humains, Insuffisance rénale chronique, Mâle, Relation dose-effet des médicaments, Statistiques comme sujet, Sujet âgé, Évaluation des résultats et des processus en soins de santé.
English descriptors
- KwdEn :
- Aged, Anemia (diagnosis), Anemia (drug therapy), Anemia (etiology), Clinical Trials, Phase III as Topic, Dose-Response Relationship, Drug, Erythropoietin (pharmacology), Female, Hematinics (pharmacology), Hemoglobins (analysis), Humans, Male, Middle Aged, Outcome and Process Assessment (Health Care), Polyethylene Glycols (pharmacology), Randomized Controlled Trials as Topic, Renal Dialysis (adverse effects), Renal Dialysis (methods), Renal Insufficiency, Chronic (complications), Renal Insufficiency, Chronic (therapy), Statistics as Topic.
- MESH :
- chemical , analysis : Hemoglobins.
- chemical , pharmacology : Erythropoietin, Hematinics, Polyethylene Glycols.
- adverse effects : Renal Dialysis.
- complications : Renal Insufficiency, Chronic.
- diagnosis : Anemia.
- drug therapy : Anemia.
- etiology : Anemia.
- methods : Renal Dialysis.
- therapy : Renal Insufficiency, Chronic.
- Aged, Clinical Trials, Phase III as Topic, Dose-Response Relationship, Drug, Female, Humans, Male, Middle Aged, Outcome and Process Assessment (Health Care), Randomized Controlled Trials as Topic, Statistics as Topic.
Abstract
Erythropoiesis-stimulating agents and iron are commonly used in patients with chronic kidney disease with the aim of correcting anemia and maintaining stable hemoglobin levels. We analyzed pooled data from 13 studies with similar designs included in the Umbrella Continuous Erythropoietin Receptor Activator (C.E.R.A.) program to investigate the effects of continuous erythropoiesis receptor activator in clinically relevant subgroups of patients with chronic kidney disease and to determine whether the efficacy and safety outcomes demonstrated in the overall chronic kidney disease population are maintained in specific subgroups.
Data from 13 Phase III trials set up with similar design were retrospectively pooled for this analysis. Patients with chronic kidney disease who had previously been receiving epoetin or darbepoetin were switched to continuous erythropoiesis receptor activator once-monthly after a 4- to 8-week screening period. Patients entered a 16-week continuous erythropoiesis receptor activator dose-titration period followed by an 8-week evaluation period. In total, 2060 patients were included in the analysis. Subgroups were defined based on: hemoglobin target range [lower (10.0–12.0 g/dL)/upper (10.5–13.0 g/dL)], gender (female/male), age (<65/≥65), baseline N-terminal pro-B-type natriuretic peptide levels (<5000/≥5000), cardiovascular risk factors (diabetes/cardiac/vascular/none).
Across all subgroups analyzed, switching from shorter-acting erythropoiesis-stimulating agents to continuous erythropoiesis receptor activator once-monthly maintained stable hemoglobin concentrations in a high proportion of patients (78%), with only moderate hemoglobin fluctuations and a low number of dose changes. The safety profile across subgroups was as expected based on pre-existing risk factors; observed increases in adverse events were attributable to underlying risk factors rather than study drug.
This retrospective analysis of 13 trials showed that continuous erythropoiesis receptor activator once-monthly maintained stable hemoglobin levels across a number of clinically relevant patient subgroups, including those with higher inherent cardiovascular risk. The safety profile was consistent with that previously established in the chronic kidney disease population.
NCT00413894/NCT00545571/NCT00517413/NCT00560404/NCT00882713/NCT00550680/NCT00576303/NCT00660023/NCT00717821/NCT00642850/NCT00605293/NCT00661505/NCT00699348.
F. Hoffmann-La Roche Ltd, Basel, Switzerland.
The online version of this article (doi:10.1007/s12325-016-0309-6) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1007/s12325-016-0309-6
PubMed: 26965694
PubMed Central: 4846713
Affiliations:
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Le document en format XML
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with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials</title><author><name sortKey="Locatelli, Francesco" sort="Locatelli, Francesco" uniqKey="Locatelli F" first="Francesco" last="Locatelli">Francesco Locatelli</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Nephrology, Dialysis and Transplantation Department, Alessandro Manzoni Hospital, Lecco, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Nephrology, Dialysis and Transplantation Department, Alessandro Manzoni Hospital, Lecco</wicri:regionArea><wicri:noRegion>Lecco</wicri:noRegion></affiliation></author><author><name sortKey="Choukroun, Gabriel" sort="Choukroun, Gabriel" uniqKey="Choukroun G" first="Gabriel" last="Choukroun">Gabriel Choukroun</name><affiliation wicri:level="3"><nlm:aff id="Aff2">Nephrology, Dialysis and Transplantation Department, CHU Amiens and University of Picardie Jules Verne, Amiens, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Nephrology, Dialysis and Transplantation Department, CHU Amiens and University of Picardie Jules Verne, Amiens</wicri:regionArea><placeName><region type="region">Hauts-de-France</region><region type="old region">Picardie</region><settlement type="city">Amiens</settlement></placeName></affiliation></author><author><name sortKey="Truman, Matt" sort="Truman, Matt" uniqKey="Truman M" first="Matt" last="Truman">Matt Truman</name><affiliation wicri:level="1"><nlm:aff id="Aff3">Roche Australia, Dee Why, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Roche Australia, Dee Why</wicri:regionArea><wicri:noRegion>Dee Why</wicri:noRegion></affiliation></author><author><name sortKey="Wiggenhauser, Alfons" sort="Wiggenhauser, Alfons" uniqKey="Wiggenhauser A" first="Alfons" last="Wiggenhauser">Alfons Wiggenhauser</name><affiliation wicri:level="1"><nlm:aff id="Aff4">Roche Pharma AG, Medical Affairs, Grenzach-Wyhlen, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Roche Pharma AG, Medical Affairs, Grenzach-Wyhlen</wicri:regionArea><wicri:noRegion>Grenzach-Wyhlen</wicri:noRegion><wicri:noRegion>Grenzach-Wyhlen</wicri:noRegion><wicri:noRegion>Grenzach-Wyhlen</wicri:noRegion></affiliation></author><author><name sortKey="Fliser, Danilo" sort="Fliser, Danilo" uniqKey="Fliser D" first="Danilo" last="Fliser">Danilo Fliser</name><affiliation wicri:level="1"><nlm:aff id="Aff5">Department of Internal Medicine IV, Saarland University Medical Centre, Homburg/Saar, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Internal Medicine IV, Saarland University Medical Centre, Homburg/Saar</wicri:regionArea><wicri:noRegion>Homburg/Saar</wicri:noRegion><wicri:noRegion>Homburg/Saar</wicri:noRegion><wicri:noRegion>Homburg/Saar</wicri:noRegion></affiliation></author></analytic><series><title level="j">Advances in Therapy</title><idno type="ISSN">0741-238X</idno><idno type="eISSN">1865-8652</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Anemia (diagnosis)</term><term>Anemia (drug therapy)</term><term>Anemia (etiology)</term><term>Clinical Trials, Phase III as Topic</term><term>Dose-Response Relationship, Drug</term><term>Erythropoietin (pharmacology)</term><term>Female</term><term>Hematinics (pharmacology)</term><term>Hemoglobins (analysis)</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Outcome and Process Assessment (Health Care)</term><term>Polyethylene Glycols (pharmacology)</term><term>Randomized Controlled Trials as Topic</term><term>Renal Dialysis (adverse effects)</term><term>Renal Dialysis (methods)</term><term>Renal Insufficiency, Chronic (complications)</term><term>Renal Insufficiency, Chronic (therapy)</term><term>Statistics as Topic</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Antianémiques (pharmacologie)</term><term>Anémie (diagnostic)</term><term>Anémie (traitement médicamenteux)</term><term>Anémie (étiologie)</term><term>Dialyse rénale ()</term><term>Dialyse rénale (effets indésirables)</term><term>Essais cliniques de phase III comme sujet</term><term>Essais contrôlés randomisés comme sujet</term><term>Femelle</term><term>Humains</term><term>Hémoglobines (analyse)</term><term>Insuffisance rénale chronique ()</term><term>Mâle</term><term>Polyéthylène glycols (pharmacologie)</term><term>Relation dose-effet des médicaments</term><term>Statistiques comme sujet</term><term>Sujet âgé</term><term>Érythropoïétine (pharmacologie)</term><term>Évaluation des résultats et des processus en soins de santé</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analysis" xml:lang="en"><term>Hemoglobins</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en"><term>Erythropoietin</term><term>Hematinics</term><term>Polyethylene Glycols</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Renal Dialysis</term></keywords><keywords scheme="MESH" qualifier="analyse" xml:lang="fr"><term>Hémoglobines</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Renal Insufficiency, Chronic</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Anemia</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Anémie</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Anemia</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Dialyse rénale</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Anemia</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Renal Dialysis</term></keywords><keywords scheme="MESH" qualifier="pharmacologie" xml:lang="fr"><term>Antianémiques</term><term>Polyéthylène glycols</term><term>Érythropoïétine</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Renal Insufficiency, Chronic</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Anémie</term></keywords><keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Anémie</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Clinical Trials, Phase III as Topic</term><term>Dose-Response Relationship, Drug</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Outcome and Process Assessment (Health Care)</term><term>Randomized Controlled Trials as Topic</term><term>Statistics as Topic</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Dialyse rénale</term><term>Essais cliniques de phase III comme sujet</term><term>Essais contrôlés randomisés comme sujet</term><term>Femelle</term><term>Humains</term><term>Insuffisance rénale chronique</term><term>Mâle</term><term>Relation dose-effet des médicaments</term><term>Statistiques comme sujet</term><term>Sujet âgé</term><term>Évaluation des résultats et des processus en soins de santé</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Introduction</title><p>Erythropoiesis-stimulating agents and iron are commonly used in patients with chronic kidney disease with the aim of correcting anemia and maintaining stable hemoglobin levels. We analyzed pooled data from 13 studies with similar designs included in the Umbrella Continuous Erythropoietin Receptor Activator (C.E.R.A.) program to investigate the effects of continuous erythropoiesis receptor activator in clinically relevant subgroups of patients with chronic kidney disease and to determine whether the efficacy and safety outcomes demonstrated in the overall chronic kidney disease population are maintained in specific subgroups.</p></sec><sec><title>Methods</title><p>Data from 13 Phase III trials set up with similar design were retrospectively pooled for this analysis. Patients with chronic kidney disease who had previously been receiving epoetin or darbepoetin were switched to continuous erythropoiesis receptor activator once-monthly after a 4- to 8-week screening period. Patients entered a 16-week continuous erythropoiesis receptor activator dose-titration period followed by an 8-week evaluation period. In total, 2060 patients were included in the analysis. Subgroups were defined based on: hemoglobin target range [lower (10.0–12.0 g/dL)/upper (10.5–13.0 g/dL)], gender (female/male), age (<65/≥65), baseline N-terminal pro-B-type natriuretic peptide levels (<5000/≥5000), cardiovascular risk factors (diabetes/cardiac/vascular/none).</p></sec><sec><title>Results</title><p>Across all subgroups analyzed, switching from shorter-acting erythropoiesis-stimulating agents to continuous erythropoiesis receptor activator once-monthly maintained stable hemoglobin concentrations in a high proportion of patients (78%), with only moderate hemoglobin fluctuations and a low number of dose changes. The safety profile across subgroups was as expected based on pre-existing risk factors; observed increases in adverse events were attributable to underlying risk factors rather than study drug.</p></sec><sec><title>Conclusions</title><p>This retrospective analysis of 13 trials showed that continuous erythropoiesis receptor activator once-monthly maintained stable hemoglobin levels across a number of clinically relevant patient subgroups, including those with higher inherent cardiovascular risk. The safety profile was consistent with that previously established in the chronic kidney disease population.</p></sec><sec><title>ClinicalTrials.gov identifiers</title><p>NCT00413894/NCT00545571/NCT00517413/NCT00560404/NCT00882713/NCT00550680/NCT00576303/NCT00660023/NCT00717821/NCT00642850/NCT00605293/NCT00661505/NCT00699348.</p></sec><sec><title>Funding</title><p>F. Hoffmann-La Roche Ltd, Basel, Switzerland.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1007/s12325-016-0309-6) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Portoles, J" uniqKey="Portoles J">J Portoles</name></author><author><name sortKey="Gorriz, Jl" uniqKey="Gorriz J">JL Gorriz</name></author><author><name sortKey="Rubio, E" uniqKey="Rubio E">E Rubio</name></author><author><name sortKey="De Alvaro, F" uniqKey="De Alvaro F">F de Alvaro</name></author><author><name sortKey="Garcia, F" uniqKey="Garcia F">F Garcia</name></author><author><name sortKey="Alvarez Chivas, V" uniqKey="Alvarez Chivas V">V Alvarez-Chivas</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Kovesdy, Cp" uniqKey="Kovesdy C">CP Kovesdy</name></author><author><name sortKey="Trivedi, Bk" uniqKey="Trivedi B">BK Trivedi</name></author><author><name sortKey="Kalantar Zadeh, K" uniqKey="Kalantar Zadeh K">K Kalantar-Zadeh</name></author><author><name sortKey="Anderson, Je" uniqKey="Anderson J">JE Anderson</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Locatelli, F" uniqKey="Locatelli F">F Locatelli</name></author><author><name sortKey="Covic, A" uniqKey="Covic A">A Covic</name></author><author><name sortKey="Eckardt, Ku" uniqKey="Eckardt K">KU Eckardt</name></author><author><name sortKey="Wiecek, A" uniqKey="Wiecek A">A Wiecek</name></author><author><name sortKey="Vanholder, R" uniqKey="Vanholder R">R Vanholder</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Locatelli, F" uniqKey="Locatelli F">F Locatelli</name></author><author><name sortKey="Del Vecchio, L" uniqKey="Del Vecchio L">L Del Vecchio</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Palmer, Sc" uniqKey="Palmer S">SC Palmer</name></author><author><name sortKey="Saglimbene, V" uniqKey="Saglimbene V">V Saglimbene</name></author><author><name sortKey="Mavridis, D" uniqKey="Mavridis D">D Mavridis</name></author><author><name sortKey="Salanti, G" uniqKey="Salanti G">G Salanti</name></author><author><name sortKey="Craig, Jc" uniqKey="Craig J">JC Craig</name></author><author><name sortKey="Tonelli, M" uniqKey="Tonelli M">M Tonelli</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Macdougall, Ic" uniqKey="Macdougall I">IC Macdougall</name></author><author><name sortKey="Robson, R" uniqKey="Robson R">R Robson</name></author><author><name sortKey="Opatrna, S" uniqKey="Opatrna S">S Opatrna</name></author><author><name sortKey="Liogier, X" uniqKey="Liogier X">X Liogier</name></author><author><name sortKey="Pannier, A" uniqKey="Pannier A">A Pannier</name></author><author><name sortKey="Jordan, P" uniqKey="Jordan P">P 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Francisco, A" uniqKey="De Francisco A">A de Francisco</name></author><author><name sortKey="Deray, G" uniqKey="Deray G">G Deray</name></author><author><name sortKey="Fliser, D" uniqKey="Fliser D">D Fliser</name></author><author><name sortKey="Armstrong, G" uniqKey="Armstrong G">G Armstrong</name></author><author><name sortKey="Dougherty, Fc" uniqKey="Dougherty F">FC Dougherty</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Locatelli, F" uniqKey="Locatelli F">F Locatelli</name></author><author><name sortKey="Altieri, P" uniqKey="Altieri P">P Altieri</name></author><author><name sortKey="Andrulli, S" uniqKey="Andrulli S">S Andrulli</name></author><author><name sortKey="Sau, G" uniqKey="Sau G">G Sau</name></author><author><name sortKey="Bolasco, P" uniqKey="Bolasco P">P Bolasco</name></author><author><name sortKey="Pedrini, La" uniqKey="Pedrini L">LA Pedrini</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Locatelli, F" uniqKey="Locatelli F">F Locatelli</name></author><author><name sortKey="Hannedouche, T" uniqKey="Hannedouche T">T Hannedouche</name></author><author><name sortKey="Martin Malo, A" uniqKey="Martin Malo A">A Martin-Malo</name></author><author><name sortKey="Jacobson, Sh" uniqKey="Jacobson S">SH Jacobson</name></author><author><name sortKey="Vanholder, R" uniqKey="Vanholder R">R Vanholder</name></author><author><name sortKey="Ronco, C" uniqKey="Ronco C">C Ronco</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Locatelli, F" uniqKey="Locatelli F">F Locatelli</name></author><author><name sortKey="Barany, P" uniqKey="Barany P">P Barany</name></author><author><name sortKey="Covic, A" uniqKey="Covic A">A Covic</name></author><author><name sortKey="De Francisco, A" uniqKey="De Francisco A">A De Francisco</name></author><author><name sortKey="Del Vecchio, L" uniqKey="Del Vecchio L">L Del Vecchio</name></author><author><name sortKey="Goldsmith, D" uniqKey="Goldsmith D">D Goldsmith</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lagrand, Wk" uniqKey="Lagrand W">WK Lagrand</name></author><author><name sortKey="Visser, Ca" uniqKey="Visser C">CA Visser</name></author><author><name sortKey="Hermens, Wt" uniqKey="Hermens W">WT Hermens</name></author><author><name sortKey="Niessen, Hw" uniqKey="Niessen H">HW Niessen</name></author><author><name sortKey="Verheugt, Fw" uniqKey="Verheugt F">FW Verheugt</name></author><author><name sortKey="Wolbink, Gj" uniqKey="Wolbink G">GJ Wolbink</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>France</li><li>Italie</li></country><region><li>Hauts-de-France</li><li>Picardie</li></region><settlement><li>Amiens</li></settlement></list><tree><country name="Italie"><noRegion><name sortKey="Locatelli, Francesco" sort="Locatelli, Francesco" uniqKey="Locatelli F" first="Francesco" last="Locatelli">Francesco Locatelli</name></noRegion></country><country name="France"><region name="Hauts-de-France"><name sortKey="Choukroun, Gabriel" sort="Choukroun, Gabriel" uniqKey="Choukroun G" first="Gabriel" last="Choukroun">Gabriel Choukroun</name></region></country><country name="Australie"><noRegion><name sortKey="Truman, Matt" sort="Truman, Matt" uniqKey="Truman M" first="Matt" last="Truman">Matt Truman</name></noRegion></country><country name="Allemagne"><noRegion><name sortKey="Wiggenhauser, Alfons" sort="Wiggenhauser, Alfons" uniqKey="Wiggenhauser A" first="Alfons" last="Wiggenhauser">Alfons Wiggenhauser</name></noRegion><name sortKey="Fliser, Danilo" sort="Fliser, Danilo" uniqKey="Fliser D" first="Danilo" last="Fliser">Danilo Fliser</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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