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Kidney Week

Abstract: PO0482

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

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Koury, Mark, Vanderbilt University Medical Center, Nashville, Tennessee, United States
  • Pergola, Pablo E., Renal Associates PA, San Antonio, Texas, United States
  • Roy-Chaudhury, Prabir, UNC School of Medicine - W. G. (Bill) Hefner VA Medical Center, Salisbury, North Carolina, United States
  • Farag, Youssef MK, Akebia Therapeutics Inc, Akebia Therapeutics Inc, Cambridge, MA, US, corporate/pharma, Cambridge, Massachusetts, United States
  • Luo, Wenli, Akebia Therapeutics Inc, Akebia Therapeutics Inc, Cambridge, MA, US, corporate/pharma, Cambridge, Massachusetts, United States
  • Anders, Robert, Akebia Therapeutics Inc, Akebia Therapeutics Inc, Cambridge, MA, US, corporate/pharma, Cambridge, Massachusetts, United States
  • Solinsky, Christine, Akebia Therapeutics Inc, Akebia Therapeutics Inc, Cambridge, MA, US, corporate/pharma, Cambridge, Massachusetts, United States
  • Vargo, Dennis, Akebia Therapeutics Inc, Akebia Therapeutics Inc, Cambridge, MA, US, corporate/pharma, Cambridge, Massachusetts, United States
  • Winkelmayer, Wolfgang C., Baylor College of Medicine, Houston, Texas, 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, sponsor-blind, active-controlled, noninferiority trials (PRO2TECT) comparing once-daily oral dosing VADA with the erythropoiesis-stimulating agent (ESA) darbepoetin alfa (DA) in 1751 patients with non–dialysis-dependent CKD (NDD-CKD) not previously ESA treated and in 1725 NDD-CKD patients previously ESA treated. Inclusion criteria included serum ferritin ≥100 ng/mL and transferrin saturation (TSAT) ≥20%. Safety and efficacy results 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 (PEP and SEP).

Results

A total of 1741 patients received VADA and 1735 received DA. VADA treatment was associated with greater decreases in mean hepcidin, ferritin, and TSAT, and increases in TIBC from baseline at PEP and SEP (Table). A small increase in serum iron was seen in the VADA group as was a decrease in the DA group from baseline to PEP and SEP. Oral and IV iron use was similar in the 2 treatment groups throughout both studies.

Conclusion

Treatment with VADA resulted in relative decreases in hepcidin and ferritin and increases in TIBC and serum iron. Decreases in TSAT should be interpreted in light of a greater increase in TIBC than that of serum iron. These changes are consistent with a VADA-induced increase in iron mobilization from extracellular stores that support erythropoiesis.

Funding

  • Commercial Support