Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Subjects With Incident 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 correction or maintenance
treatment in subjects with anemia secondary to CKD who have recently initiated dialysis
treatment for end-stage renal disease.

Inclusion Criteria:

- ≥18 years of age

- Initiated chronic maintenance dialysis (either peritoneal or hemodialysis) for
end-stage kidney disease within 16 weeks prior to Screening

- Mean Screening hemoglobin between 8.0 and <11.0 g/dL (inclusive)

Exclusion Criteria:

- Subjects meeting the criteria of ESA resistance within 8 weeks prior to or during
Screening defined as follows

1. epoetin: > 7700 units/dose three times per week or >23,000 units per week

2. darbepoetin alfa: >100 mcg/week

3. methoxy polyethylene glycol-epoetin beta: >100 mcg every other week or >200
mcg/month

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

- Anticipated to recover adequate kidney function to no longer require dialysis

- Uncontrolled hypertension

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

- Acute coronary syndrome (hospitalization for unstable angina, 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 CHF; or
stroke within 12 weeks prior to or during Screening.

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