16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis

Phase 2 Open-Label Study to Assess the Efficacy, Safety, and Tolerability of AKB-6548 in Subjects With Anemia Secondary to End Stage Renal Disease (ESRD), Undergoing Chronic Hemodialysis.

The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with end stage renal disease undergoing chronic hemodialysis.

Key Inclusion Criteria:

• 18 to 79 years inclusive
• Chronic Kidney Disease (CKD) Stage 5 on chronic hemodialysis for at least 3 months
• Anemia secondary to CKD treated with erythropoiesis stimulating agent and intravenous iron

Key Exclusion Criteria:

• Body mass index >44.0 kilograms per meter squared (kg/m^2)
• Transfusion within 8 weeks prior to Screening
• Alanine transaminase or total bilirubin >1.25x ULN
• Uncontrolled hypertension
• Class III or IV congestive heart failure
• Myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack within 6 months prior to Screening