Renal anemia: enarodustat does well in phase 2b trial

  • Akizawa T & al.
  • Am J Nephrol
  • 30 Jan 2019

  • curated by Yael Waknine
  • Clinical Essentials
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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.

Limitations

  • No active comparator.