42-Day Repeat Oral Dose Study of AKB-6548 in Subjects With Chronic Kidney Disease and Anemia

Key Inclusion Criteria:

- 18 to 79 years of age, inclusive

- Chronic Kidney Disease (eGFR <60 mL/min), not yet on dialysis

- Hemoglobin (Hgb) ≤ 10.5 g/dL

- TSAT ≥ 20%

- Ferritin ≥ 50 ng/mL

Key Exclusion Criteria:

- BMI >42

- Red blood cell transfusion within 12 weeks

- Androgen therapy within the previous 21 days prior to study dosing

- Therapy with any approved or experimental erythropoiesis stimulating agent (ESA)
within the 11 weeks prior to the Screening visit

- Subjects meeting the criteria of ESA resistance within the previous 4 months

- Individual doses of intravenous iron of greater than 250 mg within the past 21 days

- AST or ALT >1.8x ULN

- Alkaline phosphatase >2x ULN

- Total bilirubin >1.5x ULN

- Uncontrolled hypertension

- New York Heart Association Class III or IV congestive heart failure

- Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to
dosing