Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06520826

Vafseo Outcomes In-Center Experience

This trial is an investigator-initiated, multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the safety of vadadustat administered three times per week for the treatment of anemia in in-center hemodialysis patients with End Stage Kidney Disease (ESKD). This study will obtain long-term safety data in a large sample of subjects receiving in-center hemodialysis to support adoption of three times per week vadadustat dosing.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Anemia of Chronic Kidney Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

USRC Kidney Research, Lone Tree, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients greater than or equal to 18 years of age.
  • Receiving outpatient in-center hemodialysis at least three times per week for end-stage kidney disease.
  • Currently prescribed or eligible for erythropoiesis-stimulating agent based on approved facility policy
  • Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.

Exclusion criteria

  • Contraindication to receive vadadustat or any of its known constituents per USPI.
  • Cirrhosis or active, acute liver disease. Concomitant use of any hypoxia-inducible factor prolyl-hydroxylases or OAT1/OAT3 inhibitors (probenacid, rifampicin, gemfibrozil, or teriflunomide).
  • Unable to comply with study requirements or in the opinion of a healthcare provider or a member of the central study team, not clinically stable to participate in the study.
  • Pregnant at time of consent (per subject self-report).

Treatment and study plan

Vadadustat

Drug

A synthetic, orally bioavailable, small molecule being developed as an inhibitor of hypoxia-inducible factor prolyl-hydroxylases for the treatment of anemia associated with chronic kidney disease. Intervention to be administered to maintain hemoglobin within a target range of 10-11 g/dL.

Other names: Vafseo

Erythropoiesis Stimulating Agent

Drug

Standard of care erythropoiesis stimulating agent will be administered to maintain hemoglobin within a target range of 10-11 g/dL.

Other names: Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp)

Primary outcomes

  1. Combination of the hierarchical endpoints of all-cause mortality and all-cause hospitalization.

    Time frame: 18 months

    The hierarchical endpoints of all-cause mortality and all cause hospitalization will be analyzed by the win odds method with ranking all cause mortality more important than all cause hospitalization.

Secondary outcomes

  1. All-cause hospitalization

    Time frame: 18 months

    All-cause hospitalization

  2. All-cause mortality

    Time frame: 18 months

    All-cause mortality

Sponsors and collaborators

Lead sponsor

USRC Kidney Research

Network

Collaborators

  • Akebia Therapeutics

Registry information

Official study title

Safety of Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Hemodialysis Subjects: Vafseo Outcomes In-Center Experience

Acronym: VOICE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2024
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.