Vafseo Outcomes In-Center Experience (VOICE)

Safety of Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Hemodialysis Subjects: 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anemia of Chronic Kidney Disease
• Intervention / Treatment: Drug: Vadadustat; Drug: Erythropoiesis Stimulating Agent

• Study Type: Interventional
• Enrollment (Estimated): 2200
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • USRC Kidney Research
  • Georgia
    • Dalton, Georgia, United States, 30720
      • Nephrology and Hypertension Specialists, PC
  • New Mexico
    • Gallup, New Mexico, United States, 87301
      • US Renal Care - Gallup
  • Texas
    • Dallas, Texas, United States, 75230
      • Dallas Renal Group
    • Live Oak, Texas, United States, 78233
      • US Renal Care - Live Oak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vadadustat; Vadadustat, 300 mg tablets, administered orally three times per week	Drug: Vadadustat; 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
Active Comparator: Erythropoiesis-stimulating agent (ESA) - Standard of Care (SOC); Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp) administered as per standard of care	Drug: Erythropoiesis Stimulating Agent; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combination of the hierarchical endpoints of all-cause mortality and all-cause hospitalization.	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.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality	18 months
All-cause hospitalization	All-cause hospitalization	18 months

Collaborators and Investigators

• Sponsor: USRC Kidney Research
• Collaborators: Akebia Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Hematologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Biological Factors; Carbohydrates; Intercellular Signaling Peptides and Proteins; Glycoproteins; Glycoconjugates; Colony-Stimulating Factors; Hematopoietic Cell Growth Factors; Cytokines; Erythropoietin; Hematologic Agents; Epoetin Alfa; Darbepoetin alfa; Hematinics; continuous erythropoietin receptor activator; vadadustat
• Other Study ID Numbers: USRC-2024-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No