Efficacy and Safety Study to Evaluate Vadadustat for the Correction of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-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 correction of anemia and
maintenance of Hb in subjects with NDD-CKD

Inclusion Criteria:

- ≥18 years of age

- Diagnosis of CKD with an eGFR ≤60 mL/min/1.73 m^2 at Screening and not expected to
start dialysis within 6 months of Screening

- Mean Screening hemoglobin <10.0 g/dL

Exclusion Criteria:

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

- Any erythropoietic stimulating agent within 8 weeks prior to randomization

- 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 darbepoetin or vadadustat or to any of their excipients