Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia

Phase 2a Open-Label Pilot Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 28-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and/or 4

The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.

Key Inclusion Criteria:

• 18 to 79 years of age, inclusive
• Chronic Kidney Disease Stage 3 or Stage 4
• Hemoglobin (Hgb) < 10.5 g/dl
• TSAT > 20% and CBC indicating normocytic red blood cell morphology

Key Exclusion Criteria:

• BMI > 40
• 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 10 weeks prior to the Screening visit
• Participants meeting the criteria of ESA resistance within the previous 4 months
• Individual doses of intravenous iron of 250 mg or larger 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