NCT06520826

Vafseo Outcomes In-Center Experience

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,200 (estimated)
• Sponsor: USRC Kidney Research · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anemia of Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Vadadustat	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.
DRUG	Erythropoiesis Stimulating Agent	Standard of care erythropoiesis stimulating agent will be administered to maintain hemoglobin within a target range of 10-11 g/dL.

Timeline

• Start date: 2024-11-20
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-07-25
• Last updated: 2026-03-10

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study