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
NCT ID: NCT04707768
Last Updated: 2025-01-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
456 participants
INTERVENTIONAL
2021-06-18
2023-01-30
Brief Summary
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Detailed Description
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* Conversion and Maintenance Period (Weeks 0 to 52): There will be a primary efficacy evaluation period (Weeks 20 to 26) and a secondary efficacy evaluation period (Weeks 46 to 52).
* Safety Follow-up Period (Early Termination \[ET\] and Follow-Up): post-treatment safety follow-up visit (ET/End of Treatment \[EOT\] +4 weeks) either in person or via telephone.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vadadustat low dose
Participants previously receiving Mircera® received vadadustat for up to 52 weeks with an initial dose of 600 milligrams (mg).
Vadadustat
oral tablets
Vadadustat high dose
Participants previously receiving Mircera® received vadadustat for up to 52 weeks with an initial dose of 900 mg.
Vadadustat
oral tablets
Mircera®
Participants will continue to receive Mircera® for up to 52 weeks.
Mircera®
intravenous administration
Interventions
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Vadadustat
oral tablets
Mircera®
intravenous administration
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Akebia Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
Akebia Therapeutics Inc.
Locations
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Research Site
Huntsville, Alabama, United States
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
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Macon, Georgia, United States
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Nampa, Idaho, United States
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Baton Rouge, Louisiana, United States
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Shreveport, Louisiana, United States
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Plymouth, Massachusetts, United States
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Springfield, Massachusetts, United States
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Kalamazoo, Michigan, United States
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Rochester Hills, Michigan, United States
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Saint Clair Shores, Michigan, United States
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Brookhaven, Mississippi, United States
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Columbus, Mississippi, United States
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Tupelo, Mississippi, United States
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North Platte, Nebraska, United States
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Las Vegas, Nevada, United States
Research Site
Reno, Nevada, United States
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Portsmouth, New Hampshire, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Gallup, New Mexico, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Durham, North Carolina, United States
Research Site
Kinston, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Columbus, Ohio, United States
Research Site
Kittanning, Pennsylvania, United States
Research Site
Knoxville, Tennessee, United States
Research Site
Arlington, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Mansfield, Texas, United States
Research Site
Mission, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
Research Site
Alexandria, Virginia, United States
Research Site
Salem, Virginia, United States
Research Site
Woodbridge, Virginia, United States
Countries
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References
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Toka HR, Bernardo M, Burke SK, Luo W, Manllo-Karim R, Ullah I, Yang Z, Zhang Z, Tumlin J. Vadadustat Three Times Weekly in Patients With Anemia Due to Dialysis-Dependent CKD. Am J Kidney Dis. 2025 Apr;85(4):454-464.e1. doi: 10.1053/j.ajkd.2024.09.006. Epub 2024 Nov 7.
Kooienga L, Burke S, Kathresal A, Luo W, Yang Z, Zhang Z, Zwiech R, Hernandez GT. Safety and Efficacy of Vadadustat Once Daily and Three Times Weekly in Patients With Dialysis-Dependent CKD With Anemia. Kidney360. 2024 Nov 1;5(11):1652-1661. doi: 10.34067/KID.0000000567. Epub 2024 Sep 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AKB-6548-CI-0039
Identifier Type: -
Identifier Source: org_study_id
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