Vafseo Outcomes In-Center Experience

Launched by USRC KIDNEY RESEARCH · Jul 22, 2024

Keywords

ClinConnect Summary

The Vafseo Outcomes In-Center Experience trial is studying a treatment called vadadustat for patients with anemia caused by chronic kidney disease who are undergoing hemodialysis. This study aims to gather information about the long-term safety of taking vadadustat three times a week. Researchers are looking for adult patients who are at least 18 years old, receive hemodialysis at least three times a week, and are currently prescribed or eligible for other anemia treatments.

Participants in this trial will be randomly assigned to receive either vadadustat or a standard treatment, and they will be monitored for their health and safety throughout the study. It’s important for potential participants to know that they cannot join if they have certain liver conditions, are pregnant, or have other specific health issues. This study could help improve treatment options for anemia in patients with end-stage kidney disease and may lead to better care in the future.

Gender

ALL

Eligibility criteria

• 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).