Phase 3, randomized, open-label, active-controlled study evaluating the efficacy and safety of oral vadadustat for the correction of anemia in subjects with non-dialysis-dependent chronic kidney disease (ndd-ckd) (pro2tect - correction)

Inclusion Criteria:

• ≥18 years of age
• Diagnosis of CKD with an eGFR ≤60 mL/min/1.73 m2 using the 2009 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation at Screening and not expected to start dialysis within 6 months of Screening
• Mean Screening HGB <10.0 g/dL as determined by the average of 2 HGB values measured by the central laboratory during Screening
• Serum ferritin ≥100 ng/mL and transferrin saturation (TSAT) ≥20% at Screening
• Folate and vitamin B12 measurements ≥lower limit of normal at Screening
• Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.

Exlision Criteria:

• Anemia due to a cause other than CKD or subjects with active bleeding or recent blood loss
• Subjects with sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
• Red blood cell (RBC) transfusion within 4 weeks prior to or during Screening
• Intravenous (IV) iron within 4 weeks prior to Screening
• Any ESA (eg, recombinant human erythropoietin [rhEPO] or darbepoetin alfa) within 6 weeks prior to Screening
• Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT), or total bilirubin >2.0 x upper limit of normal (ULN) at Screening. Subjects with a history of Gilbert’s syndrome are not excluded.
• Uncontrolled hypertension (confirmed diastolic blood pressure >110 mmHg or systolic blood pressure >180 mmHg) at Screening
• Severe heart failure at Screening (New York Heart Association Class IV)
• Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), urgent coronary revascularization, hospitalization for CHF, or stroke within 12 weeks prior to Screening
• History of active malignancy within 2 years prior to Screening, except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or resected benign colonic polyps
• History of deep vein thrombosis (DVT) or pulmonary embolism (PE) requiring active treatment within 8 weeks prior to Screening
• History of hemosiderosis or hemochromatosis
• History of prior organ transplantation or scheduled organ transplant (subjects on kidney transplant wait-list are not excluded), or prior stem cell or bone marrow transplant (corneal transplants are not excluded)
• Use of an investigational medication or participation in an investigational study within 30 days or 5 half-lives of the investigational medication (whichever is longer), prior to the Screening visit
• Previous participation in this study, receipt of vadadustat in another study, or previous participation in a study with another hypoxia-inducible factor prolyl -hydroxylase inhibitor (HIF-PHI)
• Females who are pregnant or breast-feeding. Women of childbearing potential who are unable or unwilling to use an acceptable method of contraception
• Non-vasectomized male subjects who are unable or unwilling to use an acceptable method of contraception
• Any other reason that in the opinion of the Investigator would make the subject not suitable for participation in the study.