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To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis
Sponsor: Akebia Therapeutics
Summary
This is a multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the efficacy of vadadustat administered three times a week compared to standard of care erythropoiesis-stimulating agent for the treatment of anemia in in-center hemodialysis participants with end-stage kidney disease (ESKD). A subset of sites will participate in a red blood cell (RBC) sub-study where changes in the phenotype of RBCs in response to vadadustat treatment relative to methoxy polyethylene glycol-epoetin beta treatment in DD-CKD participants with anemia will be assessed. A separate informed consent form (ICF) will be signed by these participants who opt to be in the RBC sub-study. Of the 350 participants in the main study, approximately 28 participants will also be enrolled into the RBC sub-study. The total duration of the study is approximately 35 Weeks including screening and follow-up.
Official title: A Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy of Three Times Weekly Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
353
Start Date
2025-07-24
Completion Date
2026-08
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
Erythropoiesis-Stimulating Agent (ESA)
Administered by intra-venous (IV) infusion.
Vadadustat
300mg, oral tablets
Locations (18)
DaVita Research Site
Montgomery, Alabama, United States
DaVita Research Site
Hartford, Connecticut, United States
DaVita Research Site
Middlebury, Connecticut, United States
DaVita Research Site
Columbus, Georgia, United States
DaVita Research Site #1
Minneapolis, Minnesota, United States
DaVita Research Site
Minneapolis, Minnesota, United States
DaVita Research Site
Henderson, Nevada, United States
DaVita Research Site
Las Vegas, Nevada, United States
DaVita Research Site #1
El Paso, Texas, United States
DaVita Research Site
El Paso, Texas, United States
DaVita Research Site #1
Houston, Texas, United States
DaVita Research Site
Houston, Texas, United States
DaVita Research Site #1
San Antonio, Texas, United States
DaVita Research Site #2
San Antonio, Texas, United States
DaVita Research Site
San Antonio, Texas, United States
DaVita Research Site
The Woodlands, Texas, United States
DaVita Research Site #1
Norfolk, Virginia, United States
DaVita Research Site
Norfolk, Virginia, United States