Vafseo Outcomes In-Center Experience

Last updated: December 5, 2024
Sponsor: USRC Kidney Research
Overall Status: Active - Recruiting

Phase

3

Condition

Chronic Renal Anemia

Anemia

Treatment

Vadadustat

Erythropoiesis Stimulating Agent

Clinical Study ID

NCT06520826
USRC-2024-001
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients greater than or equal to 18 years of age.

  • Receiving outpatient in-center hemodialysis at least three times per week forend-stage kidney disease.

  • Currently prescribed or eligible for erythropoiesis-stimulating agent based onapproved facility policy

  • Understands the procedures and requirements of the study and provides writteninformed consent and authorization for protected health information disclosure.

Exclusion

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-induciblefactor prolyl-hydroxylases or OAT1/OAT3 inhibitors (probenacid, rifampicin,gemfibrozil, or teriflunomide).

  • Unable to comply with study requirements or in the opinion of a healthcare provideror a member of the central study team, not clinically stable to participate in thestudy.

  • Pregnant at time of consent (per subject self-report).

Study Design

Total Participants: 2200
Treatment Group(s): 2
Primary Treatment: Vadadustat
Phase: 3
Study Start date:
November 20, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • USRC Kidney Research

    Lone Tree, Colorado 80124
    United States

    Active - Recruiting

  • Nephrology and Hypertension Specialists, PC

    Dalton, Georgia 30720
    United States

    Active - Recruiting

  • US Renal Care - Gallup

    Gallup, New Mexico 87301
    United States

    Active - Recruiting

  • Dallas Renal Group

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • US Renal Care - Live Oak

    Live Oak, Texas 78233
    United States

    Active - Recruiting

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