caa a22 4500 445882689 CHVBK 20180317145549.0 cr unu---uuuuu 170323e20111201xx s 000 0 eng 10.1007/s10157-011-0527-9 doi (NATIONALLICENCE)springer-10.1007/s10157-011-0527-9 Darbepoetin alfa (KRN321) is safe and effective when administered subcutaneously once every 2 or 4weeks to patients on peritoneal dialysis in Japan [Elektronische Daten] [Minoru Kubota, Makoto Hiramatsu, Masato Yamakawa, Shunichi Fukuhara, Satoshi Morita, Manabu Iwasaki, Tadao Akizawa] Background: Darbepoetin alfa (KRN321) is a recombinant protein that stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Due to its longer half-life and greater biological activity than recombinant human erythropoietin (rHuEPO), KRN321 maintains an effective hemoglobin (Hb) level at extended dose intervals compared with rHuEPO. The efficacy and safety of KRN321 administered subcutaneously to patients on peritoneal dialysis (PD) were tested. Methods: In a multicenter, open-label, single-arm study, KRN321 was administered subcutaneously to patients on PD for 26-28weeks. Ninety-six patients initially were given a 60μg subcutaneous dose once every 2weeks until a target of Hb (11.0-13.0g/dL) was achieved. Thereafter, their dose was every 2 or 4weeks. Results: After the target of Hb was reached in most subjects (96.9%), it was maintained with KRN321 administered every 2 or 4weeks. On completion of (or withdrawal from) study, 65 subjects (67.7%) maintained the target Hb. Although a number of adverse event related to hypertension occurred, their incidence did not appear to be related to Hb or its rate of increase. These events could be controlled adequately by interrupting or reducing the dose, and/or treatment with antihypertensives. Conclusions: The efficacy and safety of KRN321 when administered subcutaneously for 28weeks to PD patients were confirmed. It was suggested that the quality of life of patients can be improved by treatment with KRN321 due to the reduced frequency of administration. Japanese Society of Nephrology, 2011 Anemia nationallicence Chronic renal failure patients nationallicence Darbepoetin alfa nationallicence Peritoneal dialysis nationallicence Subcutaneous administration nationallicence Kubota Minoru Department of Renal Diseases, Division of Internal Medicine, Oji Hospital, 2-14-13 Oji, Kita-ku, 114-0002, Tokyo, Japan aut Hiramatsu Makoto Okayama Saiseikai General Hospital, Okayama, Japan aut Yamakawa Masato Minato Health Co-operative Association General Hospital, Nagoya, Japan aut Fukuhara Shunichi Department of Epidemiology and Healthcare Research, Graduate School of Medicine, Kyoto University, Kyoto, Japan aut Morita Satoshi Yokohama City University General Medical Center, Yokohama, Japan aut Iwasaki Manabu Department of Computer and Information Science, Faculty of Science and Engineering, Seikei University, Musashino, Japan aut Akizawa Tadao Department of Nephrology, Division of Internal Medicine, Showa University School of Medicine, Tokyo, Japan aut Clinical and Experimental Nephrology Springer Japan 15/6(2011-12-01), 884-892 1342-1751 15:6<884 2011 15 10157 https://doi.org/10.1007/s10157-011-0527-9 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s10157-011-0527-9 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Kubota Minoru Department of Renal Diseases, Division of Internal Medicine, Oji Hospital, 2-14-13 Oji, Kita-ku, 114-0002, Tokyo, Japan aut NATIONALLICENCE 700 1- Hiramatsu Makoto Okayama Saiseikai General Hospital, Okayama, Japan aut NATIONALLICENCE 700 1- Yamakawa Masato Minato Health Co-operative Association General Hospital, Nagoya, Japan aut NATIONALLICENCE 700 1- Fukuhara Shunichi Department of Epidemiology and Healthcare Research, Graduate School of Medicine, Kyoto University, Kyoto, Japan aut NATIONALLICENCE 700 1- Morita Satoshi Yokohama City University General Medical Center, Yokohama, Japan aut NATIONALLICENCE 700 1- Iwasaki Manabu Department of Computer and Information Science, Faculty of Science and Engineering, Seikei University, Musashino, Japan aut NATIONALLICENCE 700 1- Akizawa Tadao Department of Nephrology, Division of Internal Medicine, Showa University School of Medicine, Tokyo, Japan aut NATIONALLICENCE 773 0- Clinical and Experimental Nephrology Springer Japan 15/6(2011-12-01), 884-892 1342-1751 15:6<884 2011 15 10157 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer