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Abstract: TH-PO1186

Phase 3 Study to Compare the Efficacy and Safety of Enarodustat (JTZ-951), an Oral HIF-PH Inhibitor, with Darbepoetin Alfa in Anemic Patients with CKD Receiving Maintenance Hemodialysis

Session Information

Category: Anemia and Iron Metabolism

Authors

  • Akizawa, Tadao, Showa University School of Medicine, Tokyo, Japan
  • Maeda, Kazuo, Japan Tobacco Inc., Tokyo, Japan
  • Miyazawa, Yuya, Japan Tobacco Inc., Tokyo, Japan
  • Koretomo, Ryosuke, Japan Tobacco Inc., Tokyo, Japan
Background

This phase 3 study was conducted to verify the efficacy (non-inferiority to darbepoetin alfa (DA)) and safety of enarodustat in Japanese anemic patients with CKD receiving maintenance hemodialysis in randomized, double-blind, parallel-arm comparison manner for 24 weeks.

Methods

Patients, who have been receiving a stable dose of ESAs and have protocol specified Hb criteria (Hb level of 9.5≥ g/dL and <12.0 g/dL), were randomized in 1:1 ratio to receive either enarodustat orally once daily or DA intravenously every week after switching from ESAs. The doses were adjusted every 4 weeks to maintain Hb levels within a target range (10-12 g/dL). Intravenous iron preparations were prohibited during the screening period and the initial treatment period (Week 0-4). The primary endpoint was difference in mean Hb level between arms during the evaluation period defined as Week 20-24 (non-inferiority margin: -1.0 g/dL). Other assessments included proportion of patients whose Hb level was within the target range and iron-related parameters.

Results

173 patients were randomized to receive either enarodustat (n=87) or DA (n=86). The mean Hb level of each arm during the evaluation period was 10.73 g/dL (95% CI: 10.56, 10.91) with enarodustat arm and 10.85 g/dL (95% CI: 10.72, 10.98) with DA arm. The difference between arms in the mean Hb level was -0.12 g/dL (95% CI: -0.33, 0.10), confirming the non-inferiority to DA. Proportions of patients whose Hb level was within the target range during the evaluation period were 78.2% (95% CI: 67.4, 86.8) in enarodustat arm and 88.8% (95% CI: 79.7, 94.7) in DA arm. Increase of TIBC and decrease of hepcidin were observed through Week 4 in enarodustat arm albeit after switching from ESAs. Proportions of patients who experienced any AEs or SAEs were 87.4% and 14.9% in enarodustat arm and 83.7% and 14.0% in DA arm, respectively.

Conclusion

Enarodustat was proved to be non-inferior to DA in the treatment of anemia in Japanese CKD patients receiving maintenance hemodialysis, and was generally well-tolerated.

Funding

  • Commercial Support