Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Subjects With Dialysis-dependent Chronic Kidney Disease (DD-CKD)

• Status: Completed
• Trial end date: 2020-03-30
• Target enrollment: 0
• Participant gender: All

Summary

A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in subjects with DD-CKD

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

Details

• Lead Sponsor: Akebia Therapeutics
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• ≥18 years of age

• Receiving chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease for at least 12 weeks prior to Screening

• Currently maintained on ESA therapy, with a dose received within 6 weeks prior to or during Screening

• Mean Screening Hgb between 8.0 and 11.0 g/dL (inclusive) in the US and between 9.0 and 12.0 g/dL (inclusive) outside of the US

Exclusion Criteria:

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

• 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 vadadustat, darbepoetin alfa, or any of their excipients