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Clinical Trial
. 2020 Dec;24(6):628-641.
doi: 10.1111/1744-9987.13468. Epub 2020 Feb 5.

Oral roxadustat three times weekly in ESA-naïve and ESA-converted patients with anemia of chronic kidney disease on hemodialysis: Results from two phase 3 studies

Tadao Akizawa  1 , Mai Ueno  2 , Takanori Shiga  2 , Michael Reusch  3
Affiliations
Clinical Trial

Oral roxadustat three times weekly in ESA-naïve and ESA-converted patients with anemia of chronic kidney disease on hemodialysis: Results from two phase 3 studies

Tadao Akizawa et al. Ther Apher Dial. 2020 Dec.

Abstract

Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor approved in China for anemia of dialysis-dependent chronic kidney disease (CKD). Japanese hemodialysis patients with anemia of CKD previously naïve to, or converted from, erythropoiesis-stimulating agents (ESAs) were enrolled in two open-label, noncomparative studies of titrated oral roxadustat administered three times weekly. ESA-naïve patients (n = 75) were randomized to roxadustat (initial dose, 50 or 70 mg) for 24 weeks; ESA-converted patients (n = 164) were assigned to roxadustat (initial dose, 70 or 100 mg based on prior ESA dose) for 52 weeks. Efficacy outcomes included average hemoglobin (Hb, weeks 18-24 or 46-52), change of Hb from baseline to weeks 18 to 24 (ΔHb18-24 ) or weeks 46 to 52 (ΔHb46-52 ), and maintenance rate (proportion of patients who achieved average Hb of 10.0-12.0 g/dL for weeks 18-24 or weeks 46-52). Treatment-emergent adverse events (TEAEs) were monitored. Mean (SD) Hb was 10.93 (0.79) g/dL (weeks 18-24) (ESA-Naïve Study), and 10.93 (0.69; weeks 18-24) g/dL and 11.11 (0.67; weeks 46-52) g/dL (ESA-Converted Study). Mean (SD) ΔHb18-24 was 2.26 (1.02) g/dL (ESA-Naïve Study) and -0.03 (0.90) g/dL (ESA-Converted Study); mean (SD) ΔHb46-52 was 0.12 (0.83) g/dL (ESA-Converted Study). The overall maintenance rate was 73.0% (54/74) (ESA-Naïve Study) (weeks 18-24), and 79.1% (129/163; weeks 18-24) and 71.2% (116/163; weeks 46-52) (ESA-Converted Study). Nasopharyngitis was the most common TEAE. Two deaths, considered unrelated to roxadustat, occurred in the ESA-Converted Study. Roxadustat effectively corrected and maintained Hb, regardless of previous ESA treatment, in Japanese anemic CKD patients on hemodialysis.

Keywords: anemia; chronic kidney disease; erythropoiesis-stimulating agent; hemodialysis; roxadustat.

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Conflict of interest statement

Tadao Akizawa reports personal fees from Astellas during the conduct of the study, and personal fees from: Bayer Yakuhin, Ltd.; Japan Tobacco, Inc.; GlaxoSmithKline; Kissei Pharmaceutical Co., Ltd.; Chugai Pharmaceutical Co. Ltd; Ono Pharmaceutical Co. Ltd.; Fuso Pharmaceutical Industries, Ltd.; Nipro Corporation; Kyowa Kirin; Otsuka; Sanwa; and Torii Pharmaceutical Co., Ltd. outside of the submitted work. Michael Reusch is an employee of Astellas Pharma Europe B.V. Mai Ueno and Takanori Shiga own stock in Astellas Pharma, Inc. and are employees of Astellas Pharma, Inc.

Figures

FIGURE 1
FIGURE 1
Flow diagram of the ESA‐Naïve (A) and ESA‐Converted (B) Studies. ESA, erythropoiesis‐stimulating agent; FAS, full analysis set; SAF, safety analysis set
FIGURE 2
FIGURE 2
Mean (SD) hemoglobin levels in the ESA‐Naïve Study (A) and ESA‐Converted Study (B) (full analysis set). EoT, end of treatment; ESA, erythropoiesis‐stimulating agent; PSC, prescreening; SC, screening; w, week [Correction added on 29 June 2020, after first online publication: figure 2a has been amended to correct the data points.]
See this image and copyright information in PMC

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