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Abstract: PO0262

Roxadustat Favorably Modifies Iron Indices in Patients with Non-Dialysis-Dependent CKD-Related Anemia

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Coyne, Daniel W., Washington University in Saint Louis School of Medicine, Saint Louis, Missouri, United States
  • Roger, Simon D., Renal Research, Gosford, New South Wales, Australia
  • Chou, Willis, FibroGen Inc, San Francisco, California, United States
  • Besarab, Anatole, Stanford University School of Medicine Center for Neuroscience in Women's Health, Palo Alto, California, United States
  • Leong, Robert, FibroGen Inc, San Francisco, California, United States
  • Lee, Tyson T., FibroGen Inc, San Francisco, California, United States
  • Szczech, Lynda, FibroGen Inc, San Francisco, California, United States
  • Little, Dustin J., Stanford University School of Medicine Center for Neuroscience in Women's Health, Palo Alto, California, United States
  • Yu, Kin-Hung Peony, FibroGen Inc, San Francisco, California, United States
Background

Roxadustat is an oral hypoxia–inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis by increasing endogenous erythropoietin and improving iron metabolism.

Methods

We analyzed data from a Phase 3, randomized, double-blind study (ANDES) comparing roxadustat to placebo for the treatment of anemia in NDD-CKD patients. 922 patients were randomized (2:1) to receive roxadustat (n=616) or placebo (n=306) thrice weekly with monthly dose titrations. Patients were encouraged to receive oral iron daily unless not tolerated. Change in Hb was compared to changes in key iron and red blood cell (RBC) parameters.

Results

All baseline (BL) parameters were comparable between the study arms. Roxadustat was superior to placebo in increasing mean Hb from BL over weeks (wks) 28-52: +2.00 vs. +0.16 g/dL (p<0.0001), respectively. As expected, Hb, iron and RBC parameters were unchanged over time in the placebo arm. In the roxadustat arm, significant erythropoiesis was noted with mean Hb increases of 1.52 and 1.89 g/dL at wks 4 and 24; mean decrease in hepcidin was –54.6 µg/L at wk 4 and DTIBC was +63.1 µg/dL at wk 8. An initial decline in mean ferritin and TSAT was noted primarily in the higher BL quartiles, with little change in the 2 lower BL quartiles. Serum iron increased by 13.6 µg/dL at wk 20 from baseline. All initial changes in iron parameters plateaued by wks 16-20, and remained unchanged thereafter. Reticulocyte Hb content at wk 20 were at baseline level, and it was maintained at Weeks 28- Week 52. Mean MCV was slightly increased by 1-4 fL at wk 4 before plateauing and stabilizing, while mean MCHC was unchanged.

Conclusion

Roxadustat lowered serum hepcidin, accompanied with initial decline in ferritin and TSAT in patients with high BL levels but little change in ferritin and TSAT in patients with low-normal BL levels despite active erythropoiesis. Maintenance of reticulocyte Hb content level during treatment reassures sufficient iron availability during erythropoiesis with roxadustat. These findings in iron parameters suggest that iron is efficiently absorbed and mobilized for erythropoiesis during anemia correction and Hb maintenance with roxadustat in NDD-CKD patients.

Funding

  • Commercial Support –