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Kidney Week

Abstract: PO0456

Roxadustat Effectively Treats Anemia in Dialysis-Dependent CKD (DD-CKD) Patients with Ferritin ≥500 ng/mL

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Pergola, Pablo E., Renal Associates, San Antonio, Texas, United States
  • Fishbane, Steven, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York, United States
  • Charytan, Chaim, NewYork-Presbyterian/Queens, Flushing, New York, United States
  • Tham, Stefan, Clinical Research, AstraZeneca, Gothenburg, Sweden
  • Roger, Simon D., Renal Research, Gosford, New South Wales, Australia
  • Nemeth, Elizabeta, University of California Los Angeles David Geffen School of Medicine, Los Angeles, California, United States
Background

Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, increases hemoglobin (Hb) by increasing erythropoietin and improving iron bioavailability. This pooled post hoc analysis evaluated roxadustat vs ESA in DD-CKD patients (pts) with high ferritin.

Methods

Pts were randomized to roxadustat (n=1943) or epoetin alfa (EPO; n=1947) in 3 Phase 3 DD-CKD trials (ROCKIES, SIERRAS, HIMALAYAS). Ferritin was ≥100 ng/mL at entry. EPO and intravenous (IV) iron were given per usual care for EPO; for roxadustat, dose was titrated to Hb 11±1 g/dL and IV iron limited to keep ferritin ≥100 ng/mL and transferrin saturation (TSAT) ≥20%. Pooled subgroup analyses were performed by baseline (BL) ferritin ≥500 ng/mL. P values are exploratory.

Results

At BL, 963 roxadustat and 937 EPO pts had ferritin ≥500 ng/mL: median (min-max) 838 (502-5186) vs 855 (501-4577) ng/mL. Roxadustat vs EPO BL values were balanced for mean age (56 vs 57 years), mean Hb (9.9 g/dL), and median hepcidin (305 vs 301 µg/L), serum iron (68 vs 66 µg/dL) and TSAT (34% vs 33%). Through Week (wk) 52, roxadustat maintained Hb ~11 g/dL with minimal weekly dose change; EPO maintained Hb ~10.5 g/dL with dose increases (Figure). Ferritin reduction from BL was greater with roxadustat vs EPO at wk 20 (-249 vs -202 ng/mL; P=0.01) and to wk 52 (Figure). For roxadustat vs EPO, serum iron (1.6 vs -10.7 µg/dL) and transferrin (0.35 vs 0.01 µg/dL) increased at wk 20 and hepcidin (-88 vs -51 µg/L) reduced at wk 24 (all P<0.01). IV iron use was less with roxadustat vs EPO (29% vs 37% pts).

Conclusion

In DD-CKD pts with high ferritin, EPO pts had lower Hb and impaired iron mobilization despite increased IV iron use and EPO dose. Roxadustat drove ferritin reductions and increased serum iron and transferrin, with minimal dose change, and is an alternative to ESA for DD-CKD pts with high ferritin.

Funding

  • Commercial Support