- Enarodustat was effective for correcting and maintaining Hb levels in patients with anemia due to non-dialysis-dependent chronic kidney disease (NDD-CKD).
Why this matters
- Enarodustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor warrants further study in phase 3 trials.
- Phase 2b double-blind study of 94 erythropoiesis-stimulating agent (ESA)-naive patients (correction group) and 103 ESA-stable patients (conversion group) with NDD-CKD, randomly assigned to receive 2, 4, or 6 mg enarodustat or placebo daily for 6 weeks.
- 167 patients continued into the 24-week open-label enarodustat extension study.
- Funding: Japan Tobacco, Inc.
- 6-week data in the correction group showed that Hb rose weekly in a dose-dependent manner (P<.001 and the rate was higher enarodustat vs placebo mg p=".0015;">
- Long-term extension:
- At 24 weeks, 71.4% patients in the correction group and 78.9% of those in the conversion group maintained Hb levels within target range (10.0-12.0 g/dL).
- Among patients initially receiving placebo, Hb maintenance rates at week 4 rose to 77.3% and 73.9% in the correction and conversion groups, respectively, remaining ≥70% thereafter.
- Mean daily dose was 3.58 and 3.74 mg, respectively.
- No active comparator.