ASN's Mission

To create a world without kidney diseases, the ASN Alliance for Kidney Health elevates care by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on X

Kidney Week

Abstract: TH-PO983

Safety and Efficacy of Vadadustat Thrice Weekly in Patients with Anemia due to Dialysis-Dependent CKD

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Toka, Hakan R., Nova Clinical Research, Bradenton, Florida, United States
  • Luo, Wenli, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
  • Ullah, Irfan, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
  • Yang, Zhihui (Sunny), Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
  • Zhang, Zhiqun, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
  • Burke, Steven K., Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
Background

Vadadustat (VADA) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). This study investigated the efficacy and safety of conversion from the long-acting IV erythropoiesis-stimulating agent methoxy polyethylene glycol-epoetin beta (CERA; MIRCERA®) to oral VADA thrice weekly (TIW) for the maintenance treatment of anemia in patients with dialysis-dependent chronic kidney disease (DD-CKD).

Methods

This randomized (1:1:1), open-label, active-controlled, sponsor-blinded trial compared VADA, at starting doses of 600 mg and 900 mg TIW, and CERA treatment in patients with DD-CKD for up to 52 weeks. Primary and secondary endpoints were mean change in hemoglobin (Hb) from baseline to the primary evaluation period (PEP; weeks 20–26) and secondary evaluation period (SEP; weeks 46–52), respectively (noninferiority margin, −0.75 g/dL). Other key endpoints included the proportion of patients requiring red blood cell (RBC) transfusions during the PEP and those with Hb levels >11g/dL and 12g/dL. Treatment-emergent adverse events (TEAEs) and serious TEAEs were reported as primary safety endpoints.

Results

VADA TIW (n=304) was noninferior to CERA (n=152) for mean change in Hb from baseline during the PEP (least-squares mean difference: –0.33 g/dL; 95% CI: –0.53, –0.13) and SEP (–0.33 g/dL; 95% CI: –0.56, –0.09). The percentage of patients receiving RBC transfusions during the PEP was 3% for both groups. The proportion of patients with Hb levels >11g/dL and 12g/dL were lower in the VADA group (61.6% and 20.5%, respectively) vs the CERA group (78.2% and 30.6%, respectively). VADA and CERA had similar incidences of TEAEs and serious TEAEs. The proportion of patients with TEAEs resulting in death was 9% in the VADA group and 11% in the CERA group. The most common TEAEs were COVID-19 and diarrhea in both groups. Incidence of cardiac arrest was more common in the CERA group (7.3%) compared to the VADA group (1.7%). No differences in abnormal liver enzymes were observed between treatment groups.

Conclusion

VADA TIW was noninferior to CERA in Hb efficacy. VADA had a lower proportion of patients with Hb excursions compared to CERA. The incidence of TEAEs and serious TEAEs was similar between VADA and CERA.

Funding

  • Commercial Support – Akebia Therapeutics, Inc.