- Roxadustat bested placebo for correcting anemia in a phase 3 trial of patients with non-dialysis-dependent chronic kidney disease (NDD-CKD).
Why this matters
- The hypoxia-inducible factor prolyl hydroxylase inhibitor represents a potential first-in-class treatment option.
- Findings may herald a “revolution in the treatment of anemia in chronic kidney disease,” writes Joshua Kaplan, MD, in an accompanying editorial.
- Double-blind, multicenter trial, 154 patients in China with NDD-CKD randomly allocated 2:1 to receive roxadustat or placebo 3x weekly for 8 weeks, followed by an 18-week open-label roxadustat extension period.
- Mean baseline hemoglobin was 7-10 g/dL; 54% had transferrin saturation ≥20%; 38% had ferritin ≥200 μg/L.
- Funding: FibroGen.
- Over weeks 7-9, mean hemoglobin increased 1.9±1.2 g/dL with roxadustat and decreased 0.4±0.8 g/dL with placebo (P<.001 style="list-style-type:circle;">
- 67% achieved mean hemoglobin ≥10.0 g/dL (vs placebo, 6%).
- Long-term safety unknown.
- These results accompany another set of trial findings reporting roxadustat vs placebo for dialysis-dependent CKD.