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

Phase 2a Randomized, Double-Blind, Placebo-Controlled, Dose Range Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 42-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and 4

The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in pre-dialysis participants with anemia with repeat dosing for 42 days.

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
• Transferring saturation ≥ 20%
• Ferritin ≥ 50 ng/mL

Key Exclusion Criteria:

• Body mass index >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
• Participants 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
• Aspartate aminotransferase or alanine aminotransferase >1.8x upper limit of normal (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