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Active, not recruitingNCT06520826VOICEUpdated Mar 10, 2026

Vafseo Outcomes In-Center Experience

A Phase 3 interventional study of Vadadustat and Erythropoiesis Stimulating Agent in Anemia of Chronic Kidney Disease, sponsored by USRC Kidney Research. Active, not recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by USRC Kidney Research · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
2,200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Anemia of Chronic Kidney Disease
03

In context

Lead sponsor

USRC Kidney Research is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,200 participants (estimated)

Study arms

  • Experimental
    Vadadustat

    Vadadustat, 300 mg tablets, administered orally three times per week

    Drug: Vadadustat

  • 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

Interventions

  • DrugVadadustat

    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.

    Also known as: Vafseo

  • DrugErythropoiesis Stimulating Agent

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

    Also known as: Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 18 months

Secondary outcomes

  1. All-cause hospitalization

    All-cause hospitalization

    Time frame: 18 months

  2. All-cause mortality

    All-cause mortality

    Time frame: 18 months

07

Study locations

5 sites
  • USRC Kidney Research
    Lone Tree, Colorado 80124, United States
  • Nephrology and Hypertension Specialists, PC
    Dalton, Georgia 30720, United States
  • US Renal Care - Gallup
    Gallup, New Mexico 87301, United States
  • Dallas Renal Group
    Dallas, Texas 75230, United States
  • US Renal Care - Live Oak
    Live Oak, Texas 78233, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06520826
Lead sponsor
USRC Kidney Research
Collaborators
Akebia Therapeutics
Responsible party
Sponsor
First posted
Jul 25, 2024
Start date
Nov 20, 2024
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Mar 10, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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