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Kidney Week

Abstract: PO0457

Iron-Related Outcomes in Patients with Dialysis-Dependent CKD Randomized to Vadadustat vs. Darbepoetin Alfa

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Winkelmayer, Wolfgang C., Baylor College of Medicine, Houston, Texas, United States
  • Fishbane, Steven, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, United States
  • Tumlin, James A., Emory University School of Medicine, Atlanta, Georgia, United States
  • Farag, Youssef MK, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
  • Luo, Wenli, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
  • Anders, Robert, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
  • Solinsky, Christine, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
  • Vargo, Dennis, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
  • Koury, Mark, Vanderbilt University Medical Center, Nashville, Tennessee, United States
Background

Vadadustat (VADA) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor being investigated for treatment of anemia due to chronic kidney disease (CKD).

Methods

We conducted 2 global phase 3, randomized, open-label, active-controlled, noninferiority trials (INNO2VATE) comparing once-daily oral dosing of VADA with the erythropoiesis-stimulating agent darbepoetin alfa (DA) in patients with anemia and incident (N=369) or prevalent (N=3554) dialysis-dependent (DD) CKD. Inclusion criteria: serum ferritin ≥100 ng/mL and transferrin saturation (TSAT) ≥20%. Safety and efficacy results of the INNO2VATE trials were previously reported. Here we report iron-related outcomes, including the changes in mean serum hepcidin, ferritin, total iron-binding capacity (TIBC), iron, and TSAT from baseline to the primary (wk 24–36) and secondary (wk 40–52) evaluation periods.

Results

A total of 1958 patients received VADA and 1965 received DA. VADA treatment was associated with greater decreases in mean hepcidin and ferritin, and increases in TIBC from baseline to the primary and secondary evaluation periods (Table). Mean serum iron decreased more in the DA than the VADA group from baseline to wk 24–36 and 40–52. Oral and intravenous iron use was similar in the 2 treatment groups throughout both studies. Similar results were seen in the non–DD-CKD populations (PRO2TECT studies).

Conclusion

The observed relative decreases in hepcidin and ferritin and the increase in TIBC are consistent with a VADA-induced facilitation of iron mobilization from intracellular stores that support erythropoiesis.

Funding

  • Commercial Support