Revised study design.

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)

Inclusion Criteria:

• Male and female subjects ≥18 years of age
• Receiving chronic maintenance in-center hemodialysis (3 times per week) for end-stage kidney disease
• Currently maintained on ESA therapy
• Mean screening Hb between 8.0 and 11.0 g/dL (inclusive)

Exclusion Criteria:

• Anemia due to a cause other than CKD or presence of active bleeding or recent blood loss
• Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
• Red blood cell transfusion within 4 weeks prior to or during screening
• Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation