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)

Completed · Phase 3

Conditions studied: Anemia, Dialysis-Dependent Chronic Kidney Disease

In brief

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).

Key facts

Study ID

NCT02865850

Run by

Akebia Therapeutics

People needed

369

Starts

2016-07-01

Expected to finish

2020-03-30

Last updated by the study team

2022-07-18

Who can join

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

You may qualify if…

• ≥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

You may not qualify if…

• 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
• epoetin: > 7700 units/dose three times per week or >23,000 units per week
• Darbepoetin alfa: >100 micrograms per week (mcg/week)
• 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

Where it is running

• Research Site — Mesa, Arizona, United States
• Research Site — Anaheim, California, United States
• Research Site — Canyon Country, California, United States
• Research Site — Downey, 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 — Long Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Montebello, California, United States
• Research Site — Monterey Park, California, United States
• Research Site — Newhall, California, United States
• Research Site #1 — Northridge, California, United States
• Research Site #2 — Northridge, California, United States
• Research Site — Riverside, California, United States
• Research Site — Riverside, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Dimas, California, United States
• Research Site — Whittier, California, United States
• Research Site — Arvada, Colorado, United States
• Research Site — Westminster, Colorado, United States
• Research Site — Stamford, Connecticut, United States
• Research Site — Coral Gables, Florida, United States
• Research Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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