Efficacy and Safety Study to Evaluate Vadadustat for the Correction of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

• Status: Completed
• Trial end date: 2020-07-31
• Target enrollment: 0
• Participant gender: All

Summary

A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in subjects with NDD-CKD

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akebia Therapeutics
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• ≥18 years of age

• Diagnosis of CKD with an eGFR ≤60 mL/min/1.73 m^2 at Screening and not expected to start dialysis within 6 months of Screening

• Mean Screening hemoglobin <10.0 g/dL

Exclusion Criteria:

• Anemia due to a cause other than CKD or subjects with active bleeding or recent blood loss

• Any erythropoietic stimulating agent within 8 weeks prior to randomization

• Uncontrolled hypertension

• Severe heart failure at Screening (New York Heart Association Class IV)

• Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular, or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for HF, or stroke within 12 weeks prior to or during Screening

• Hypersensitivity to darbepoetin or vadadustat or to any of their excipients