Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Subjects With Dialysis-dependent Chronic Kidney Disease (DD-CKD)

This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the
efficacy and safety of vadadustat versus darbepoetin alfa for the maintenance treatment of
anemia in subjects with DD-CKD

Inclusion Criteria:

- ≥18 years of age

- Receiving chronic maintenance dialysis (either peritoneal or hemodialysis) for
end-stage kidney disease for at least 12 weeks prior to Screening

- Currently maintained on ESA therapy, with a dose received within 6 weeks prior to or
during Screening

- Mean Screening Hgb between 8.0 and 11.0 g/dL (inclusive) in the US and between 9.0 and
12.0 g/dL (inclusive) outside of the US

Exclusion Criteria:

- Anemia due to a cause other than CKD or subjects with active bleeding or recent blood
loss

- Uncontrolled hypertension

- Severe heart failure at Screening (New York Heart Association Class IV)

- Acute coronary syndrome (hospitalization for unstable angina or myocardial
infarction), surgical or percutaneous intervention for coronary, cerebrovascular or
peripheral artery disease (aortic or lower extremity), surgical or percutaneous
valvular replacement or repair, sustained ventricular tachycardia, hospitalization for
HF, or stroke within 12 weeks prior to or during Screening

- Hypersensitivity to vadadustat, darbepoetin alfa, or any of their excipients