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

Completed · Phase 3

Conditions studied: Anemia, Non-Dialysis-Dependent Chronic Kidney Disease

In brief

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)

Key facts

Study ID

NCT02648347

Run by

Akebia Therapeutics

People needed

1751

Starts

2015-12-01

Expected to finish

2020-07-31

Last updated by the study team

2022-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

• 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

Where it is running

• Research Site — Tuscumbia, Alabama, United States
• Research Site — Glendale, Arizona, United States
• Research Site — Mesa, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Anaheim, California, United States
• Research Site — Bakersfield, California, United States
• Research Site #1 — Chula Vista, California, United States
• Research Site #2 — Chula Vista, California, United States
• Research Site #1 — Fountain Valley, California, United States
• Research Site #2 — Fountain Valley, California, United States
• Research Site — Glendale, California, United States
• Research Site — Granada Hills, California, United States
• Research Site — La Mesa, California, United States
• Research Site — Laguna Hills, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Lynwood, California, United States
• Research Site #2 — Northridge, California, United States
• Research Site — Northridge, California, United States
• Research Site — Riverside, California, United States
• Research Site — Roseville, California, United States
• Research Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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