Vafseo Outcomes In-Center Experience

Description

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.

Conditions

Anemia of Chronic Kidney Disease

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Study Overview

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Study Details

Study overview

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.

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

Vafseo Outcomes In-Center Experience

Condition
Anemia of Chronic Kidney Disease
Intervention / Treatment

-

Contacts and Locations

Lone Tree

USRC Kidney Research, Lone Tree, Colorado, United States, 80124

Dalton

Nephrology and Hypertension Specialists, PC, Dalton, Georgia, United States, 30720

Gallup

US Renal Care - Gallup, Gallup, New Mexico, United States, 87301

Dallas

Dallas Renal Group, Dallas, Texas, United States, 75230

Live Oak

US Renal Care - Live Oak, Live Oak, Texas, United States, 78233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

USRC Kidney Research,

Study Record Dates

2026-06-30