RECRUITING

Vafseo Outcomes In-Center Experience

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-11-20
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06520826

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients greater than or equal to 18 years of age.
  2. * Receiving outpatient in-center hemodialysis at least three times per week for end-stage kidney disease.
  3. * Currently prescribed or eligible for erythropoiesis-stimulating agent based on approved facility policy
  4. * Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
  1. * Contraindication to receive vadadustat or any of its known constituents per USPI.
  2. * Cirrhosis or active, acute liver disease. Concomitant use of any hypoxia-inducible factor prolyl-hydroxylases or OAT1/OAT3 inhibitors (probenacid, rifampicin, gemfibrozil, or teriflunomide).
  3. * 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.
  4. * Pregnant at time of consent (per subject self-report).

Contacts and Locations

Study Contact

Stephanie Brillhart, MSCI
CONTACT
3038819451
stephanie.brillhart@usrenalcare.com
Martha Block, RN, CCRP
CONTACT
7205912533
martha.block@usrenalcare.com

Study Locations (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

Collaborators and Investigators

Sponsor: USRC Kidney Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-20
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2024-11-20
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Anemia of Chronic Kidney Disease