Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With 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 maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (DD-CKD)
Key facts
- Study ID
- NCT02892149
- Run by
- Akebia Therapeutics
- People needed
- 3554
- Starts
- 2016-08-01
- Expected to finish
- 2020-03-30
- Last updated by the study team
- 2022-06-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥18 years of age
- Receiving chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease for at least 12 weeks prior to Screening
- Currently maintained on erythropoiesis-stimulating agent 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 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
You may not qualify if…
- Anemia due to a cause other than chronic kidney disease or participants with active bleeding or recent blood loss
- Uncontrolled hypertension
- Red blood cell transfusion within 8 weeks prior to randomization
- Anticipated to recover adequate kidney function to no longer require dialysis
- 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 Vadadustat, Darbepoetin alfa, or any of their excipients
Where it is running
- Research Site — Mesa, Arizona, United States
- Research Site — Pine Bluff, Arkansas, United States
- Research Site — Anaheim, California, United States
- Research Site #1 — Bakersfield, California, United States
- Research Site #2 — Bakersfield, California, United States
- Research Site — Canyon Country, California, United States
- Research Site — Chula Vista, California, United States
- Research Site — Downey, California, United States
- Research Site — El Centro, California, United States
- Research Site — Escondido, California, United States
- Research Site — Fairfield, California, United States
- Research Site — Glendale, California, United States
- Research Site #1 — Granada Hills, California, United States
- Research Site #2 — Granada Hills, California, United States
- Research Site — La Habra, California, United States
- Research Site — La Mesa, California, United States
- Research Site — Lakewood, California, United States
- Research Site — Long Beach, 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 #1 — Montebello, California, United States
- Research Site — Monterey Park, California, United States
- Research Site — Newhall, California, United States
- Research Site — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
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