Long-Term Safety and Efficacy of JR-131, a Biosimilar of Darbepoetin Alfa, in Japanese Patients With Renal Anemia Undergoing Hemodialysis: Phase 3 Prospective Study

• 西, 愼一

• Yamada, Masayuki

• Tsuruya, Kazuhiko

• Masakane, Ikuto

• Nakamoto, Hidetomo

抄録

The objective of this study was to evaluate the safety and efficacy of JR-131, a biosimilar of darbepoetin alfa, for long-term treatment of renal anemia patients undergoing hemodialysis. In this multicenter, single-arm, phase 3 study, 159 patients with renal anemia who had been receiving darbepoetin alfa or recombinant human erythropoietins were treated with intravenous JR-131 for 52 weeks. In patients receiving darbepoetin alfa, JR-131 was administered at the same dose, while in patients receiving recombinant human erythropoietin the dose was determined based on the 1:200 conversion ratio following the Japanese darbepoetin alfa package insert. No notable adverse drug reactions were reported, and no anti-JR-131 antibodies were detected. The hemoglobin levels were maintained in the range of 10.0-12.0 g/dL throughout the study. JR-131 proved to be a useful and lower-cost alternative to darbepoetin alfa in the management of renal anemia in patients undergoing hemodialysis.

収録刊行物

• Therapeutic Apheresis and Dialysis

  Therapeutic Apheresis and Dialysis 24 (2), 136-145, 2020-04

  Wiley

キーワード

• Biosimilar
• Darbepoetin alfa
• Erythropoiesis-stimulating agent
• JR-131
• Long-term study

詳細情報

• CRID: 1050856995322566656
• NII論文ID: 120006811109
• ISSN: 17449987
• ISSN: 17449979
• HANDLE: 20.500.14094/90006840
• Web Site: https://search.jamas.or.jp/link/ui/2021312596
• 本文言語コード: en
• 資料種別: journal article
• データソース種別:
  • IRDB
  • CiNii Articles