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

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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

NCT02680574
2015-004774-14 (EudraCT Number)
AKB-6548-CI-0015

Details and patient eligibility

About

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

Enrollment

1,725 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
  • Currently maintained on erythropoiesis-stimulating agents 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 United States (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 CKD or participant with active bleeding or recent blood loss
  • Red blood cell transfusion 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)

1,725 participants in 2 patient groups

Vadadustat
Experimental group
Treatment:
Drug: Vadadustat
Darbepoetin alfa
Active Comparator group
Treatment:
Drug: Darbepoetin alfa

Trial documents
2

Trial contacts and locations

503

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Data sourced from clinicaltrials.gov

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