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Abstract: TH-OR03

Roxadustat Treatment of Anemia in Non-Dialysis-Dependent CKD Is Not Influenced by Iron Status

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Provenzano, Robert, Wayne State University, Detroit, Michigan, United States
  • Fishbane, Steven, Northwell Health, Great Neck, New York, United States
  • Coyne, Daniel W., Washington University in Saint Louis, Saint Louis, Missouri, United States
  • Pollock, Carol A., Royal North Shore Hospital, St Leonards, New South Wales, Australia
  • Pola, Maksym, AstraZeneca, Warsaw, Poland
  • Chou, Willis, FibroGen Inc, San Francisco, California, United States
  • Saikali, Khalil Georges, FibroGen Inc, San Francisco, California, United States
  • Yu, Kin-Hung Peony, FibroGen Inc, San Francisco, California, United States
Background

Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor for anemia in CKD, improves iron absorption and bioavailability. This analysis of Phase 3 studies explored the efficacy of roxadustat in pts with non-dialysis-dependent (NDD) CKD with iron repletion or depletion at baseline.

Methods

Data from 3 completed randomized Phase 3 studies in NDD-CKD pts were analyzed individually and in the pooled population by iron status. Pts were randomized to roxadustat or placebo for up to 4 years. Baseline (BL) hemoglobin (Hb) and change from BL (CFB) were summarized overall and in pts with iron repletion or iron depletion. Iron repletion was defined as ferritin ≥100 μg/L and transferrin saturation (TSAT) ≥20%; the remainder were defined as iron depleted. Oral iron was allowed on study and IV iron was allowed as rescue.

Results

Across studies, 2391 and 1886 pts with NDD-CKD were treated with roxadustat and placebo, respectively. Mean (SD) BL Hb was 9.10 (0.74) g/dL (roxadustat) and 9.10 (0.73) g/dL (placebo). At BL, 1433 (60%) pts were iron replete for roxadustat and 1127 (60%) pts were iron replete for placebo. Mean CFB in Hb with roxadustat was summarized by study and iron status (Table 1). Hb CFB was similar in iron-replete and -depleted patients receiving roxadustat. Roxadustat dose and iron use in subgroups will be explored.

Conclusion

Roxadustat corrected and maintained Hb in patients with NDD-CKD and anemia regardless of iron status at baseline.

Change from baseline in Hb overall and by iron status with roxadustat treatment across NDD studies over Weeks 28 to 52 regardless of rescue therapy
StudyN in analysisMean (SD) baseline Hb for study (g/dL)Adjusted LS mean Change from baseline in Hb
001
(OLYMPUS)
Overall = 13849.11 (0.73)1.75 (0.03)†
Iron-replete = 7821.71 (0.04)†
Iron-depleted = 5521.76 (0.05)†
060
(ANDES)
Overall = 6169.10 (0.75)2.02 (0.04)†
Iron-replete = 3661.98 (0.05)†
Iron-depleted = 2412.10 (0.07)†
608
(ALPS)
Overall = 3919.08 (0.76)1.99 (1.82, 2.16)§
Iron-replete = 2041.97 (1.74, 2.20)§
Iron-depleted = 1871.99 (1.69, 2.29)§
PooledOverall = 23919.10 (0.74)1.94 (0.02)†
Iron-replete = 14331.94 (0.03)†
Iron-depleted = 9561.94 (0.03)†
†Least squares mean change from baseline to average during Weeks 28–52 (± standard error) in the intention to treat population for overall results; least squares mean change from baseline to average during Weeks 28–36 (± standard error) in the FAS population for baseline iron subgroup results.
§Least squares mean change from baseline to average Hb during Weeks 28-52 (95% confidence interval) in the all randomized population.
Least squares mean was derived using the multiple imputation strategy by combining the results of the ANCOVA model with other covariates.
For 001, iron replete was defined as ferritin >100 μg/L and transferrin saturation >20%.
For 001, iron depleted was defined as ferritin <100 μg/L and <20%.
Hb, hemoglobin; LS, least squares; NDD, non-dialysis dependent; standard deviation, SD.

Funding

  • Commercial Support