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Kidney Week

Abstract: TH-PO226

Enarodustat (JTZ-951), an Oral HIF-PH Inhibitor, Maintains Hemoglobin Levels Switching from ESAs over 30 Weeks in Japanese Anemic Patients with CKD Receiving Maintenance Hemodialysis

Session Information

Category: Anemia and Iron Metabolism

  • 202 Anemia and Iron Metabolism: Clinical

Authors

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

The dose response in Hb and safety of enarodustat administered for 6 weeks was assessed in anemic patients with CKD receiving maintenance hemodialysis (HD-CKD) in a placebo-controlled, randomized, double-blind manner (period I). In addition, the maintenance dosage and safety of long-term treatment with enarodustat was assessed in an open-label manner for 24 weeks (period II).

Methods

Subjects, who have been receiving a stable dose of ESAs and have protocol specified Hb criteria, were randomized in 1:1:1:1 ratio to receive either enarodustat doses of 2, 4, 6 mg or placebo once daily and switched from ESAs. Subjects, who completed the period I and were eligible for the period II, received long-term treatment with enarodustat that was adjusted in the range of 2 to 8 mg to maintain Hb in a target range of 10.0-12.0. Use of IV iron was prohibited by the end of period I.

Results

In period I, the changes in Hb from baseline at endpoint were increased with dose. In period II, the proportion of subjects who maintained Hb level within the target range on Ext Week 24 and end of treatment were 70.9% and 65.1%, respectively. Beside Hb levels were within a target range, approximately 80% subjects experienced ≤ 2 dose adjustments during period II. Mean prescribed dose was 4.30 mg/day. Median hepcidin and ferritin levels were decreased across all the enarodustat arms during period I in contrast with increase in TIBC levels. These parameters remained stable during period II. Enarodustat was generally well tolerated.

Conclusion

Enarodustat maintained Hb levels in anemic patients with HD-CKD switching from ESAs with minimum dose adjustment requirement. Furthermore, iron availability and utilization by enarodustat are suggested to be contributed to erythropoietic responses, which is expected to provide alternative and more physiologic treatment option to ESA for anemic patients with CKD. The efficacy and safety compared with ESA and long-term studies are being examined in phase 3 studies.

Funding

  • Commercial Support