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Vafseo Outcomes In-Center Experience
Sponsor: USRC Kidney Research
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.
Official title: Safety of Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Hemodialysis Subjects: Vafseo Outcomes In-Center Experience
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2200
Start Date
2024-11-20
Completion Date
2026-06-30
Last Updated
2026-03-10
Healthy Volunteers
No
Conditions
Interventions
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.
Erythropoiesis Stimulating Agent
Standard of care erythropoiesis stimulating agent will be administered to maintain hemoglobin within a target range of 10-11 g/dL.
Locations (5)
USRC Kidney Research
Lone Tree, Colorado, United States
Nephrology and Hypertension Specialists, PC
Dalton, Georgia, United States
US Renal Care - Gallup
Gallup, New Mexico, United States
Dallas Renal Group
Dallas, Texas, United States
US Renal Care - Live Oak
Live Oak, Texas, United States