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A Phase 3 study of vadadustat for the treatment of anemia in late-stage CKD patients

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Trial Profile

A Phase 3 study of vadadustat for the treatment of anemia in late-stage CKD patients

Status: Withdrawn prior to enrolment
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2025

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At a glance

  • Drugs Vadadustat (Primary)
  • Indications Anaemia
  • Focus Therapeutic Use
  • Acronyms VALOR

Most Recent Events

  • 29 Oct 2025 Status changed from planning to withdrawn prior to enrolment.
  • 29 Oct 2025 According to a Akebia Therapeutics media release, from the face-to-face Type C meeting, based on the FDA feedback, Akebia believes regulatory alignment for such a trial would require a significantly larger number of patients than proposed, and accordingly would require meaningfully more time and cost to complete.
  • 29 Oct 2025 According to a Akebia Therapeutics media release, company announced that after meeting with the U.S. Food and Drug Administration (FDA) it has not come to alignment on a path forward for the design of the VALOR clinical trial for the use of vadadustat to treat anemia in patients with late-stage chronic kidney disease (CKD) not on dialysis. As a result, Akebia does not plan to initiate VALOR and therefore does not expect to pursue a broad label for Vafseo for CKD non-dialysis dependent patients.

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