| Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis. | |
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MedLine Citation:
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PMID: 19863881 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: The recombinant human epoetin-a HX575 (Sandoz Pharmaceuticals GmbH/Hexal AG, Holzkirchen, Germany) is the first biosimilar erythropoiesis-stimulating agent (ESA) with marketing authorization in Europe. The primary objective of the study was the evaluation of therapeutic equivalence in terms of hemoglobin (Hb) response of HX575 compared with the comparator product (EPREX/ ERYPO, Janssen-Cilag/Ortho Biotech, Neuss, Germany) in the long-term intravenous (i.v.) treatment of anemia in chronic renal failure patients on hemodialysis following a 1 : 1 dose conversion from the comparator product to HX575. METHODS: Hemodialysis patients with Hb levels of 10.0 - 13.0 g/dl were randomized to either continue their current i.v. epoetin-a treatment or switch to HX575. During treatment, epoetin dosages were titrated to maintain Hb values. The primary endpoint was the difference between treatment groups in the mean absolute change of Hb levels between baseline and evaluation period (Weeks 25 - 28). RESULTS: Therapeutic equivalence of HX575 and the comparator epoetin-alpha, assessed during the evaluation period, was statistically confirmed: mean changes in Hb levels were 0.15 +/- 0.09 g/dl in the HX575 and 0.06 +/- 0.12 g/dl in the comparator epoetin-a group, with a difference between groups of 0.08 g/dl (95% confidence interval: -0.17; 0.34). Hb levels and epoetin dosages remained stable throughout the entire study period of 56 weeks. The long-term safety profile of HX575 was similar to that of the comparator epoetin-alpha. No antibody formation was detected. CONCLUSIONS: The study demonstrated therapeutic equivalence of biosimilar HX575 to the comparator epoetin-a, together with a comparable safety profile. |
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Authors:
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M Haag-Weber; A Vetter; U Thyroff-Friesinger; |
Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Clinical nephrology Volume: 72 ISSN: 0301-0430 ISO Abbreviation: Clin. Nephrol. Publication Date: 2009 Nov |
Date Detail:
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Created Date: 2009-10-29 Completed Date: 2010-01-13 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0364441 Medline TA: Clin Nephrol Country: Germany |
Other Details:
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Languages: eng Pagination: 380-90 Citation Subset: IM |
Affiliation:
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Kuratorium f??r Dialyse und Nierentransplantation e.V., Straubing, Germany. marianne.haag-weber@kfh-dialyse.de |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Aged, 80 and over Anemia / blood, drug therapy*, etiology Double-Blind Method Epoetin Alfa / adverse effects, therapeutic use* Female Hematinics / adverse effects, therapeutic use* Hemoglobins / analysis Humans Kidney Failure, Chronic / complications*, therapy Male Middle Aged Renal Dialysis* Therapeutic Equivalency Young Adult |
| Chemical | |
Reg. No./Substance:
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0/HX575; 0/Hematinics; 0/Hemoglobins; 113427-24-0/Epoetin Alfa |
| Investigator | |
Investigator/Affiliation:
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Peter Balcke / ; Helmut Graf / ; Josef Kovarik / ; Leo M Marosi / ; Gert M Mayer / ; Ulrich Neyer / ; Hans Krister Stummvoll / ; Herwig Holzer / ; Peter Kotanko / ; Marianne Haag-Weber / ; Harald Achenbach / ; Kirsten Anding-Rost / ; Hans-Gernot Asmus / ; Patrick Biggar / ; Christof Blaser / ; Norbert Bockreiss / ; Gert-Peter Dragoun / ; Volkmar Gl??ser / ; Grit Glombig / ; Maximilian Goller / ; Hermann Haller / ; Marc Heydenreich / ; Frank Heyder / ; G??nther Kraatz / ; R??diger Krallinger / ; Rolfdieter Krause / ; Friedrich Lazarus / ; Sabine Ludewig / ; Klaus-J??rgen Lukowski / ; Thomas Meyer / ; Bernhard Riedl / ; Uwe Rothenpieler / ; Andreas Schmitt / ; Bernhard Schober / ; Heide Sperschneider / ; Walter Schulz / ; Petra Schulz / ; Bruno Spohn / ; Thomas Strack / ; Thomas Wichelhaus / ; Holger Franke / ; Bernhard Frye / ; Angelika Kirpal / ; Helmut Kr??mer / ; Gunnar Schaeffer / ; Dirk Schaumann / ; Michael T??pfer / ; G??nter Hartmann / ; J??rg Schiele / ; Michael Riedasch / ; Stefan Holzmann / ; Johann Knee / ; Matthias Anders / ; Hans-Dieter Hoffmann / ; Gerd Perschon / ; Peter Maria Rob / ; Stefan Holzmann / ; Detlev Adler / ; Martin Troeltsch / ; Norbert Heni / |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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