Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease

Akebia Therapeutics

Status and phase: Completed; Phase 3

Conditions: Anemia; Non-Dialysis-Dependent Chronic Kidney Disease

Treatments: Drug: Vadadustat; Drug: Darbepoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT02648347

2015-004265-81 (EudraCT Number)

AKB-6548-CI-0014

Details and patient eligibility

About

A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-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 correction of anemia and maintenance of Hb in participants with NDD-CKD

Enrollment: 1,751 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years of age
• Diagnosis of chronic kidney disease (CKD) with an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) at Screening and not expected to start dialysis within 6 months of Screening
• Mean Screening hemoglobin <10.0 grams per deciliter (g/dL)
• Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening

Exclusion criteria

• Anemia due to a cause other than CKD or participants with active bleeding or recent blood loss
• Red blood cell transfusion within 8 weeks prior to randomization.
• 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 heart failure, or stroke within 12 weeks prior to or during Screening
• Hypersensitivity to Darbepoetin or Vadadustat or to any of their excipients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,751 participants in 2 patient groups

Vadadustat

Experimental group

Treatment:

Drug: Vadadustat

Darbepoetin alfa

Active Comparator group

Treatment:

Drug: Darbepoetin alfa