Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

• Vadadustat (Drug), also known as AKB-6548: Oral tablet
• Darbepoetin alfa (Drug), also known as Aranesp: subcutaneous or intravenous

Primary outcomes

• Mean change in Hb between baseline and the primary evaluation period [Baseline visit, Week 36]: Mean change in hemoglobin will be evaluated

Secondary outcomes

• Mean change in Hb between baseline and the secondary evaluation period [Baseline visit, Week 52]: Mean change in hemoglobin will be evaluated
• Proportion of subjects with mean Hb within the target range during the primary evaluation period [Baseline visit, Week 36]: Hemoglobin values within the target range will be evaluated
• Adverse Events (AEs) and Serious Adverse Events (SAEs) [52 weeks]: Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Male and female subjects ≥18 years of age
* Receiving chronic maintenance in-center hemodialysis (3 times per week) for end-stage kidney disease
* Currently maintained on ESA therapy
* Mean screening Hb between 8.0 and 11.0 g/dL (inclusive)

Exclusion Criteria:

* Anemia due to a cause other than CKD or presence of active bleeding or recent blood loss
* Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
* Red blood cell transfusion within 4 weeks prior to or during screening
* Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation

• Akebia Therapeutics, Study director, Sponsor GmbH