This is a Phase 3 Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Oral tablet
subcutaneous or intravenous
Research Site
Northridge, California, United States
Mean change in Hb between baseline and the primary evaluation period
Mean change in hemoglobin will be evaluated
Time frame: Baseline visit, Week 36
Mean change in Hb between baseline and the secondary evaluation period
Mean change in hemoglobin will be evaluated
Time frame: Baseline visit, Week 52
Proportion of subjects with mean Hb within the target range during the primary evaluation period
Hemoglobin values within the target range will be evaluated
Time frame: Baseline visit, Week 36
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated
Time frame: 52 weeks
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