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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
353
Administered by intra-venous (IV) infusion.
300mg, oral tablets
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
...and 8 more locations
Change in hemoglobin (Hb)
Time frame: Baseline and the mean of Week 20 to 24
Number of participants reporting treatment-emergent serious adverse events (TESAEs)
Time frame: Up to 29 Weeks
Proportion of participants with mean Hb levels within target range
Time frame: Week 16 to Week 24
Proportion of participants receiving RBC transfusions
Time frame: Up to 29 Weeks
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