Kidney Week

Abstract: INFO10-FR

Three Times Weekly In-Center Vadadustat vs. Standard of Care Erythropoiesis-Stimulating Agent (ESA) for Treatment of CKD-Related Anemia in Patients Undergoing Dialysis (VOCAL)

Session Information

• Informational Posters - 2
  November 07, 2025 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Anemia and Iron Metabolism

• No subcategory defined

Authors

• Borgi, Lea, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States

Lea Borgi, MD, MMSc

• Minga, Todd Eric, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States

Todd Eric Minga, MD

• Luo, Wenli, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States

Wenli Luo, MD, PhD

• Burke, Steven K., Akebia Therapeutics Inc, Cambridge, Massachusetts, United States

Steven K. Burke, MD

• Tentori, Francesca, DaVita Inc, Denver, Colorado, United States

Francesca Tentori, MD, MS

• Brunelli, Steven M., DaVita Inc, Denver, Colorado, United States

Steven M. Brunelli, MD

Description

Background: Vadadustat (VADA) is a HIF-PHI approved by the FDA for once-daily (QD) dosing as treatment for CKD-related anemia in adults receiving dialysis for at least 3 months. Three-times weekly (TIW) dosing, which aligns with the typical schedule for in-center hemodialysis (ICHD), may provide a safe and convenient alternative. This study aims to confirm the efficacy of TIW VADA treatment compared to standard of care (SOC) ESA treatment that was first reported in the FO₂CUS trial (ClinicalTrials.gov Identifier: NCT04707768).

Methods: This phase 3b, randomized, open-label, active controlled study (NCT06901505) will evaluate TIW dosing of VADA compared to SOC ESA in approximately 350 adult patients with CKD-related anemia receiving TIW ICHD and requiring ESA treatment. During the treatment period (study week 0-24), patients will be randomized 1:1 to VADA TIW or to remain on prior ESA. Initial VADA dose will be based on prior Hb levels: 600mg TIW if Hb 11-11.49 g/dL or 900mg TIW if Hb <11 g/dL; thereafter VADA will be titrated every 2-4 weeks per protocol based on hemoglobin level and trend. For controls, ESA will be titrated per SOC protocol. After the treatment period, there will be a 4-week safety follow-up. The primary endpoint will be the difference (VADA - SOC ESA) in mean change in Hb between baseline and weeks 20-24. For efficacy, noninferiority will be established if the lower bound of the 95% CI is ≥ -0.75 g/dL. Secondary endpoints will include serious adverse events, proportion of participants with mean Hb within target range and proportion of patients receiving RBC transfusions. (Figure)

Results: The results will be presented in subsequent publications.

Conclusions: This study will provide additional data on the efficacy of TIW vadadustat compared to SOC ESA for the treatment of anemia in patients receiving TIW ICHD.

Funding

• Akebia Therapeutics, Inc.