PMID- 22732334 OWN - NLM STAT- MEDLINE DCOM- 20120807 LR - 20190608 IS - 0301-0430 (Print) IS - 0301-0430 (Linking) VI - 78 IP - 1 DP - 2012 Jul TI - Prospective multicenter study of HX575 (biosimilar epoetin-alpha) in patients with chronic kidney disease applying a target hemoglobin of 10--12 g/dl. PG - 24-32 AB - HX575 was approved in the European Union in August 2007 as the first-ever biosimilar epoetin-alpha product. The present study extended the safety database on HX575 by monitoring adverse events (AEs) in clinical practice. Hemoglobin (Hb) levels and HX575 doses were recorded for the assessment of efficacy. This open, 6-month single-arm study was conducted in 10 European countries with a target enrollment of 1,500 patients with anemia due to chronic kidney disease (CKD). HX575 was intravenously (i.v.) administered aiming at an Hb target of 10 - 12 g/dl. Most patients (92.3%) had already received erythropoiesis stimulating agents (ESAs) treatment before enrolment into this study; the recorded treatments mainly comprised i.v. or subcutaneous (s.c.) administration of epoetin-alpha, epoetin-beta or darbepoetin. The study period covered 770 patient years. The observed AE profile was in line with expectations for this patient population. Thrombotic vascular events (TVEs) were reported in 11.9% of patients (0.2612 per patient year). Tumor incidence was 1.4% (0.0299 per patient year). No subject developed anti-epoetin antibodies. Mean Hb levels were effectively maintained between 11.2 and 11.3 g/dl following the conversion from a broad spectrum of pre-study ESA treatments with stable overall mean i.v. HX575 doses. The proportion of patients within the Hb target range increased from 57.5% at baseline to 66.8% at study end. FAU - Horl, Walter H AU - Horl WH AD - Division of Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria. FAU - Locatelli, Francesco AU - Locatelli F FAU - Haag-Weber, Marianne AU - Haag-Weber M FAU - Ode, Marite AU - Ode M FAU - Roth, Karsten AU - Roth K CN - Epo-PASS study group LA - eng SI - ClinicalTrials.gov/NCT00632125 PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - Germany TA - Clin Nephrol JT - Clinical nephrology JID - 0364441 RN - 0 (Biomarkers) RN - 0 (Biosimilar Pharmaceuticals) RN - 0 (Hematinics) RN - 0 (Hemoglobins) RN - 0 (Recombinant Proteins) RN - 11096-26-7 (Erythropoietin) RN - 64FS3BFH5W (Epoetin Alfa) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Anemia/blood/*drug therapy MH - Biomarkers/blood MH - Biosimilar Pharmaceuticals/adverse effects/*therapeutic use MH - Chronic Disease MH - Epoetin Alfa MH - Erythropoietin/adverse effects/immunology/*therapeutic use MH - Europe MH - Female MH - Hematinics/adverse effects/immunology/*therapeutic use MH - Hemoglobins/*metabolism MH - Humans MH - Injections, Intravenous MH - Kidney Diseases/blood/*drug therapy MH - Male MH - Middle Aged MH - Neoplasms/chemically induced MH - Prospective Studies MH - Recombinant Proteins/adverse effects/immunology/therapeutic use MH - Thrombosis/chemically induced MH - Time Factors MH - Treatment Outcome MH - Young Adult FIR - Horl, Walter IR - Horl W FIR - Lhotta, Karl IR - Lhotta K FIR - Loipl, Johann IR - Loipl J FIR - Huspek, Michael IR - Huspek M FIR - Gstottenbauer, Klaus IR - Gstottenbauer K FIR - Karagyozova, Radka IR - Karagyozova R FIR - Monova, Daniela IR - Monova D FIR - Shikov, Petar IR - Shikov P FIR - Yovchev, Totyo IR - Yovchev T FIR - Bazeva, Petya IR - Bazeva P FIR - Nenchev, Nencho IR - Nenchev N FIR - Charasse, Christophe IR - Charasse C FIR - Haag-Weber, Marianne IR - Haag-Weber M FIR - Bockreiss, Norbert IR - Bockreiss N FIR - Buhl, Martin IR - Buhl M FIR - Dellanna, Frank IR - Dellanna F FIR - Dragoun, Gert-Peter IR - Dragoun GP FIR - Goller, Maximilian IR - Goller M FIR - Klingbeil, Arnfried IR - Klingbeil A FIR - Knee, Johann IR - Knee J FIR - Krallinger, Rudiger IR - Krallinger R FIR - Menzer, Thilo IR - Menzer T FIR - Perschon, Gerd IR - Perschon G FIR - Toussaint, Kai IR - Toussaint K FIR - Wichelhaus, Thomas IR - Wichelhaus T FIR - Kreuzer, Knut IR - Kreuzer K FIR - Bruckner, Dieter IR - Bruckner D FIR - Leistikow, Frank IR - Leistikow F FIR - Marsen, Tobias IR - Marsen T FIR - Sacherer, Kay IR - Sacherer K FIR - Zimmermann, Ulrich IR - Zimmermann U FIR - Kohnle, Matthias IR - Kohnle M FIR - Riedasch, Michael IR - Riedasch M FIR - Brehm, Klaus IR - Brehm K FIR - Vogt, Jurgen IR - Vogt J FIR - Morgenroth, Andreas IR - Morgenroth A FIR - Herrnberger, Sven IR - Herrnberger S FIR - Zeh, Matthias IR - Zeh M FIR - Dammerboer, Christoph IR - Dammerboer C FIR - Hofmann, Torsten IR - Hofmann T FIR - Kraemer-Guth, Annette IR - Kraemer-Guth A FIR - Wilpert, Jochen IR - Wilpert J FIR - Proschild, Frank IR - Proschild F FIR - Kramer, Bernhard IR - Kramer B FIR - Lang, Rainer IR - Lang R FIR - Zanker, Bernd IR - Zanker B FIR - Lubrich-Birkner, Iris IR - Lubrich-Birkner I FIR - Hemstege, Markus IR - Hemstege M FIR - Jakel, Dagmar IR - Jakel D FIR - Perino, Sabine IR - Perino S FIR - Riedl, Bernhard IR - Riedl B FIR - Assenmacher, Achim IR - Assenmacher A FIR - Locatelli, Francesco IR - Locatelli F FIR - Albertazzi, Alberto IR - Albertazzi A FIR - Colussi, Giacomo IR - Colussi G FIR - Garibotto, Giacomo IR - Garibotto G FIR - Villa, Giuseppe IR - Villa G FIR - Gesualdo, Loreto IR - Gesualdo L FIR - Triolo, Giorgio IR - Triolo G FIR - Cusi, Daniele IR - Cusi D FIR - Gallieni, Maurizio IR - Gallieni M FIR - Quarello, Francesco IR - Quarello F FIR - Malberti, Fabio IR - Malberti F FIR - Stefoni, Sergio IR - Stefoni S FIR - Tarchini, Renzo IR - Tarchini R FIR - Di Iorio, Biagio Raffaele IR - Di Iorio BR FIR - Di Luca, Marina IR - Di Luca M FIR - Bordoni, Enrico IR - Bordoni E FIR - Brunori, Giuliano IR - Brunori G FIR - Della Grotta, Franco IR - Della Grotta F FIR - Fracasso, Agostino IR - Fracasso A FIR - Guerrini, Eleonora IR - Guerrini E FIR - Ragaiolo, Mauro IR - Ragaiolo M FIR - Costanzo, Riccardo IR - Costanzo R FIR - Teatini, Ugo IR - Teatini U FIR - Dimitrov, Slave IR - Dimitrov S FIR - Sikole, Aleksandar IR - Sikole A FIR - Zabzun, Mustafa IR - Zabzun M FIR - Janakievska, Pavlina IR - Janakievska P FIR - Petrovska, Tonkica IR - Petrovska T FIR - Rzanikoski, Trajce IR - Rzanikoski T FIR - Alceva, Margarita IR - Alceva M FIR - Panova, Borka IR - Panova B FIR - Daniewska, Dorota IR - Daniewska D FIR - Klatko, Wieslaw IR - Klatko W FIR - Stryjewski, Dariusz IR - Stryjewski D FIR - Ksiazek, Andrzej IR - Ksiazek A FIR - Kopecka-Mechlinska, Lucyna IR - Kopecka-Mechlinska L FIR - Kedzierski, Piotr IR - Kedzierski P FIR - Nowicki, Michal IR - Nowicki M FIR - Szurkowski, Michal IR - Szurkowski M FIR - Paplinski, Marek IR - Paplinski M FIR - Trafny, Ryszard IR - Trafny R FIR - Kuczera, Marian IR - Kuczera M FIR - Sokalski, Antoni IR - Sokalski A FIR - Rydzewski, Andrzej IR - Rydzewski A FIR - Liberek, Tomasz IR - Liberek T FIR - Uzar, Jerzy IR - Uzar J FIR - Bako, Gabriel-Cristian IR - Bako GC FIR - Ionescu, Dorin IR - Ionescu D FIR - Voiculescu, Mihai IR - Voiculescu M FIR - Ardelean, Luminita-Catalina IR - Ardelean LC FIR - Pitea, Iancu-Viorel IR - Pitea IV FIR - Demina, Larisa IR - Demina L FIR - Borsukov, Alexey IR - Borsukov A FIR - Marasaev, Vyacheslav IR - Marasaev V FIR - Fedosseev, Anatoly IR - Fedosseev A FIR - Dudar, Iryna IR - Dudar I FIR - Kolesnyk, Mykola IR - Kolesnyk M FIR - Kostynenko, Tetiana IR - Kostynenko T FIR - Kuchma, Igor IR - Kuchma I FIR - Kuriata, Oleksandr IR - Kuriata O FIR - Lesovoy, Vladimir IR - Lesovoy V FIR - Martynyuk, Liliya IR - Martynyuk L FIR - Nikonenko, Oleksandr IR - Nikonenko O EDAT- 2012/06/27 06:00 MHDA- 2012/08/08 06:00 CRDT- 2012/06/27 06:00 PHST- 2012/06/27 06:00 [entrez] PHST- 2012/06/27 06:00 [pubmed] PHST- 2012/08/08 06:00 [medline] AID - 9782 [pii] AID - 10.5414/cn107440 [doi] PST - ppublish SO - Clin Nephrol. 2012 Jul;78(1):24-32. doi: 10.5414/cn107440.