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

Key Inclusion Criteria:

- 18 to 82 years of age, inclusive

- Chronic Kidney Disease with a GFR category of G3a-G5 and not yet on dialysis

- eGFR ≥ 10 and ≤ 65 mL/minute/1.73 m2

- Anemia secondary to CKD with an ESA status and a Screening HGB as per protocol

- Iron replete with ferritin and TSAT levels as defined per protocol

Key Exclusion Criteria:

- BMI > 44.0 kg/m2

- Red blood cell transfusion within 11 weeks prior to the Screening visit

- Androgen therapy within the previous 21 days prior to the Screening visit

- Intravenous iron within the past 4 weeks prior to the Screening visit

- AST or ALT >1.8x ULN, alkaline phosphatase >2x ULN, or total bilirubin >1.5x ULN

- Screening ECG with QTc > 500 msec

- Uncontrolled hypertension

- Class III or IV congestive heart failure

- Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to the
Screening visit