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

Akebia Therapeutics

Status and phase: Completed; Phase 3

Conditions: Anemia; Dialysis-Dependent Chronic Kidney Disease

Treatments: Drug: Darbepoetin alfa; Drug: Vadadustat

Study type: Interventional

Funder types: Industry

Identifiers

NCT02892149

AKB-6548-CI-0017

2016-001360-11 (EudraCT Number)

Details and patient eligibility

About

A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (DD-CKD)

Full description

This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the efficacy and safety of Vadadustat versus Darbepoetin alfa for the maintenance treatment of anemia in participants with DD-CKD

Enrollment: 3,554 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 erythropoiesis-stimulating agent therapy, with a dose received within 6 weeks prior to or during Screening
• Mean Screening hemoglobin between 8.0 and 11.0 grams per deciliter (g/dL) (inclusive) in the US and between 9.0 and 12.0 g/dL (inclusive) outside of the US
• Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening

Exclusion criteria

• Anemia due to a cause other than chronic kidney disease or participants with active bleeding or recent blood loss
• Uncontrolled hypertension
• Red blood cell transfusion within 8 weeks prior to randomization
• Anticipated to recover adequate kidney function to no longer require dialysis
• 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 heart failure, or stroke within 12 weeks prior to or during Screening
• Hypersensitivity to Vadadustat, Darbepoetin alfa, or any of their excipients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

3,554 participants in 2 patient groups

Vadadustat

Experimental group

Treatment:

Drug: Vadadustat

Darbepoetin alfa

Active Comparator group

Treatment:

Drug: Darbepoetin alfa