Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident 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

NCT02865850

AKB-6548-CI-0016

2016-000838-21 (EudraCT Number)

Details and patient eligibility

About

A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or maintenance treatment of anemia in participants with incident 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 correction or maintenance treatment in participants with anemia secondary to chronic kidney disease who have recently initiated dialysis treatment for end-stage renal disease.

Enrollment

369 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥18 years of age
Initiated chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease within 16 weeks prior to Screening
Mean Screening hemoglobin between 8.0 and <11.0 grams per deciliter (g/dL) (inclusive)
Serum ferritin ≥100 nanograms per deciliter (ng/mL) and 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
Red blood cells transfusion within 8 weeks prior to randomization
Anticipated to recover adequate kidney function to no longer require dialysis
Uncontrolled hypertension
Severe heart failure at Screening (New York Heart Association Class IV)
Acute coronary syndrome (hospitalization for unstable angina, 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 congestive heart failure; or stroke within 12 weeks prior to or during Screening.
Participants meeting the criteria of erythropoiesis-stimulating agent resistance within 8 weeks prior to or during Screening defined as follows
1. epoetin: > 7700 units/dose three times per week or >23,000 units per week
2. Darbepoetin alfa: >100 micrograms per week (mcg/week)
3. methoxy polyethylene glycol-epoetin beta: >100 micrograms (mcg) every other week or >200 mcg/month
Hypersensitivity to Vadadustat, Darbepoetin alfa or any of their excipients