Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)

Completed · Phase 3

Conditions studied: Anemia

In brief

This trial will be conducted to demonstrate the efficacy and safety of vadadustat compared to darbepoetin alfa for the maintenance treatment of anemia in hemodialysis participants after conversion from current erythropoiesis-stimulating agent (ESA) therapy.

Key facts

Study ID

NCT04313153

Run by

Akebia Therapeutics

People needed

319

Starts

2020-05-27

Expected to finish

2022-06-22

Last updated by the study team

2025-05-22

Who can join

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

You may qualify if…

• Receiving chronic, outpatient three times weekly (TIW) in-center hemodialysis for end-stage renal disease for at least 12 weeks prior to Screening
• Hemodialysis adequacy as indicated by single-pool Kt/Vurea ≥ 1.2 using the most recent historical measurement within 8 weeks prior to or during Screening
• Use of any approved erythropoiesis-stimulating agents (ESAs) for at least the 8 weeks prior to Screening Visit 2
• Two hemoglobin (Hb) values, at least 4 days apart, measured by the central laboratory during Screening within the following prespecified ranges:
• Hb values between 8.0 and 11.0 grams per deciliter (g/dL) (inclusive) in the United States;
• Hb values between 9.0 and 12.0 g/dL (inclusive) in Europe
• Serum ferritin ≥ 100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥ 20% during Screening
• Folate and vitamin B12 measurements ≥ lower limit of normal during Screening

You may not qualify if…

• Anemia due to a cause other than chronic kidney disease (e.g., sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia)
• Participants meeting cut-off of the following equivalent mean weekly doses calculated over 8 weeks prior to Screening Visit 2
• Methoxy polyethylene glycol-epoetin beta > 50 micrograms (µg)/week;
• Darbepoetin alfa > 100 µg/week;
• Epoetin analogues > 23000 International Units (IU)/week
• Active bleeding or recent blood loss within 8 weeks prior to randomization
• Red blood cell transfusion within 8 weeks prior to randomization
• Current uncontrolled hypertension.
• 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 (HF) or New York Heart Association Class IV HF, or stroke within 12 weeks prior to or during Screening.
• Known hypersensitivity to vadadustat, darbepoetin alfa, or any of their excipients

Where it is running

• Research Site — Granada Hills, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Lynwood, California, United States
• Research Site — Northridge, California, United States
• Research Site — San Dimas, California, United States
• Research Site — Whittier, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Middlebury, Connecticut, United States
• Research Site — Coral Gables, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Winter Park, Florida, United States
• Research Site — Pontiac, Michigan, United States
• Research Site — Roseville, Michigan, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Brookhaven, Mississippi, United States
• Research Site — Tupelo, Mississippi, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Albuquerque, New Mexico, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Kinston, North Carolina, United States
• Research Site — New Bern, North Carolina, United States
• Research Site — Bethlehem, Pennsylvania, United States
• Research Site — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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