Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects

Completed · Phase 3

Conditions studied: Anemia Associated With Chronic Kidney Disease (CKD)

In brief

This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of anemia in hemodialysis participants.

Key facts

Study ID: NCT04707768
Run by: Akebia Therapeutics
People needed: 456
Starts: 2021-06-18
Expected to finish: 2023-01-30
Last updated by the study team: 2025-01-15

Who can join

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

You may qualify if…

≥18 years of age
Receiving chronic, outpatient in-center hemodialysis three times weekly (TIW) for end-stage kidney disease for at least 12 weeks prior to Screening Visit 1 (SV1)
Currently maintained on Mircera® (≤250 μg/month) with at least 2 doses received within 8 weeks prior to Screening Visit 2 (SV2)
Mean Screening hemoglobin (Hb) between 8.5 and 11.0 grams per deciliter (g/dL) (inclusive), as determined by the average of 2 Hb values measured by the central laboratory at least 4 days apart between SV1 and SV2
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 (CKD).
Clinically meaningful bleeding event within 8 weeks prior to Baseline
Red blood cell (RBC) transfusion within 8 weeks prior to Baseline
Having received any doses of darbepoetin alfa (Aranesp®) within 4 weeks prior to Baseline
Having received any doses of epoetin alfa (Epogen®) within 1 week prior to Baseline.
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, Mircera®, or any of their excipients.

Where it is running

Research Site — Phoenix, Arizona, United States
Research Site — Pine Bluff, Arkansas, United States
Research Site — El Centro, California, United States
Research Site — Escondido, California, United States
Research Site — Fresno, California, United States
Research Site — Granada Hills, California, United States
Research Site — Porterville, California, United States
Research Site — San Diego, California, United States
Research Site — Arvada, Colorado, United States
Research Site — Denver, Colorado, United States
Research Site — Hockessin, Delaware, United States
Research Site — Bradenton, Florida, United States
Research Site — Coral Gables, Florida, United States
Research Site#1 — Coral Springs, Florida, United States
Research Site#2 — Coral Springs, Florida, United States
Research Site — Jacksonville, Florida, United States
Research Site — Athens, Georgia, United States
Research Site — Buford, Georgia, United States
Research Site — Dalton, Georgia, United States
Research Site — Macon, Georgia, United States
Research Site — Nampa, Idaho, United States
Research Site — Baton Rouge, Louisiana, United States
Research Site — Shreveport, Louisiana, United States
Research Site — Plymouth, Massachusetts, United States
Research Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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