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Abstract: TH-PO982

Real-World Clinical Use of Roxadustat in Patients with Anemia of CKD: Interim Results from a Post-Marketing Surveillance Study in Japan

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism


  • Abe, Shusaku, Astellas Pharma Inc, Tokyo, Japan
  • Sugamori, Haruko, Astellas Pharma Inc, Tokyo, Japan
  • Tanaka, Yusuke, Astellas Pharma Inc, Tokyo, Japan
  • Tsuruya, Kazuhiko, Nara Medical University, Nara, Japan

Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved in Japan to treat anemia of non-dialysis-dependent (NDD) or dialysis-dependent (DD) chronic kidney disease (CKD). A post-marketing surveillance study is underway in Japan to examine the safety and effectiveness of roxadustat in real-world clinical use. Here, we report the results of a planned interim analysis from this study.


This open-label, non-comparative, non-interventional observational study had an observation period of 104 weeks. Eligible patients had anemia of CKD and were naive to roxadustat. Enrollment began in June 2020 (DD CKD patients receiving hemodialysis [HD] or peritoneal dialysis [PD]) and January 2021 (NDD CKD), with a planned interim analysis as of December 16, 2022. Incidence of adverse drug reactions (ADRs), including specified safety outcomes, and change in mean hemoglobin (Hb) level were reported descriptively after 12 weeks of roxadustat treatment.


In total, 1468 patients (safety analysis population: NDD: 768; HD: 608; PD: 90; 2 patients received both HD and PD) were analyzed. A total of 839 patients (57.2%) switched from erythropoiesis-stimulating agents (ESA) to roxadustat, 16 patients (1.1%) concomitantly used ESA and roxadustat, 586 patients (39.9%) were ESA-naive, 23 patients switched from a HIF-PHI (1.6%), and 4 (0.3%) were missing data for prior ESA use. ADRs and serious ADRs occurred in 17.03% and 6.54% (overall), 13.02% and 3.52% (NDD CKD), 20.39% and 9.70% (HD), and 25.56% and 10.00% (PD), respectively (Table). Mean Hb level (g/dL) changed from 9.82 at baseline to 11.79 (NDD CKD), 9.83 at baseline to 11.06 (HD), and 10.22 at baseline to 11.21 (PD) after 12 weeks of roxadustat treatment.


The results from this interim analysis of a post-marketing surveillance study in Japan found that the incidence of ADRs was similar to the known roxadustat safety profile and showed the effectiveness of roxadustat in patients with anemia of CKD in clinical practice for up to 12 weeks.

Table. Incidence of ADRs and Serious ADRs


  • Commercial Support – This study was funded by Astellas Pharma, Inc.