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
A Randomized, Open-label, Active-controlled 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
1 other identifier
interventional
456
1 country
58
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2021
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2021
CompletedStudy Start
First participant enrolled
June 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2023
CompletedResults Posted
Study results publicly available
January 15, 2025
CompletedJanuary 15, 2025
December 1, 2024
1.6 years
January 12, 2021
December 23, 2024
December 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26)
The Baseline Hb was defined as the average of last 2 central laboratory Hb measurements of samples taken at or prior to the first dose. The average for the PEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 20 through 26. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as PEP value minus the Baseline value.
Baseline; Weeks 20 to 26
Secondary Outcomes (1)
Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52)
Baseline; Weeks 46 to 52
Study Arms (3)
Vadadustat low dose
EXPERIMENTALParticipants previously receiving Mircera® received vadadustat for up to 52 weeks with an initial dose of 600 milligrams (mg).
Vadadustat high dose
EXPERIMENTALParticipants previously receiving Mircera® received vadadustat for up to 52 weeks with an initial dose of 900 mg.
Mircera®
ACTIVE COMPARATORParticipants will continue to receive Mircera® for up to 52 weeks.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Research Site
Huntsville, Alabama, 35805, United States
Research Site
Phoenix, Arizona, 85035, United States
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Pine Bluff, Arkansas, 71603, United States
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El Centro, California, 92243, United States
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Escondido, California, 92025, United States
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Fresno, California, 93720, United States
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Granada Hills, California, 91344, United States
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Porterville, California, 93257, United States
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San Diego, California, 92111, United States
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Arvada, Colorado, 80002, United States
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Denver, Colorado, 80210, United States
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Hockessin, Delaware, 19707, United States
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Bradenton, Florida, 34209, United States
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Coral Gables, Florida, 33134, United States
Research Site#1
Coral Springs, Florida, 33071, United States
Research Site#2
Coral Springs, Florida, 33071, United States
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Jacksonville, Florida, 32216, United States
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Athens, Georgia, 30606, United States
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Buford, Georgia, 30518, United States
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Dalton, Georgia, 30720, United States
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Macon, Georgia, 31201, United States
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Nampa, Idaho, 83687, United States
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Baton Rouge, Louisiana, 70884, United States
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Shreveport, Louisiana, 71101, United States
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Plymouth, Massachusetts, 02360, United States
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Springfield, Massachusetts, 01107, United States
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Kalamazoo, Michigan, 49007, United States
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Rochester Hills, Michigan, 48309, United States
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Saint Clair Shores, Michigan, 48081, United States
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Brookhaven, Mississippi, 39601, United States
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Columbus, Mississippi, 39705, United States
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Tupelo, Mississippi, 38801, United States
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North Platte, Nebraska, 69101, United States
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Las Vegas, Nevada, 89115, United States
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Reno, Nevada, 89511, United States
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Portsmouth, New Hampshire, 03801, United States
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Albuquerque, New Mexico, 87109, United States
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Gallup, New Mexico, 87301, United States
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Charlotte, North Carolina, 28204, United States
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Durham, North Carolina, 27704, United States
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Kinston, North Carolina, 28504, United States
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Raleigh, North Carolina, 27609, United States
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Columbus, Ohio, 43215, United States
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Kittanning, Pennsylvania, 16201, United States
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Knoxville, Tennessee, 37923, United States
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Arlington, Texas, 76015, United States
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Austin, Texas, 78758, United States
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Dallas, Texas, 75230, United States
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Dallas, Texas, 75231, United States
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Houston, Texas, 77074, United States
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Houston, Texas, 77099, United States
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Mansfield, Texas, 76063, United States
Research Site
Mission, Texas, 78572, United States
Research Site
San Antonio, Texas, 78211, United States
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San Antonio, Texas, 78251, United States
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Alexandria, Virginia, 22304, United States
Research Site
Salem, Virginia, 24153, United States
Research Site
Woodbridge, Virginia, 22192, United States
Related Publications (2)
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.
PMID: 39521398DERIVEDKooienga 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.
PMID: 39231617DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Akebia Therapeutics, Inc.
- Organization
- Akebia Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
Akebia Therapeutics Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2021
First Posted
January 13, 2021
Study Start
June 18, 2021
Primary Completion
January 6, 2023
Study Completion
January 30, 2023
Last Updated
January 15, 2025
Results First Posted
January 15, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share