Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2200 participants
INTERVENTIONAL
2024-11-20
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vadadustat
Vadadustat, 300 mg tablets, administered orally three times per week
Vadadustat
A synthetic, orally bioavailable, small molecule being developed as an inhibitor of hypoxia-inducible factor prolyl-hydroxylases for the treatment of anemia associated with chronic kidney disease. Intervention to be administered to maintain hemoglobin within a target range of 10-11 g/dL.
Erythropoiesis-stimulating agent (ESA) - Standard of Care (SOC)
Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp) administered as per standard of care
Erythropoiesis Stimulating Agent
Standard of care erythropoiesis stimulating agent will be administered to maintain hemoglobin within a target range of 10-11 g/dL.
Interventions
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Vadadustat
A synthetic, orally bioavailable, small molecule being developed as an inhibitor of hypoxia-inducible factor prolyl-hydroxylases for the treatment of anemia associated with chronic kidney disease. Intervention to be administered to maintain hemoglobin within a target range of 10-11 g/dL.
Erythropoiesis Stimulating Agent
Standard of care erythropoiesis stimulating agent will be administered to maintain hemoglobin within a target range of 10-11 g/dL.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving outpatient in-center hemodialysis at least three times per week for end-stage kidney disease.
* Currently prescribed or eligible for erythropoiesis-stimulating agent based on approved facility policy
* Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
Exclusion Criteria
* Cirrhosis or active, acute liver disease. Concomitant use of any hypoxia-inducible factor prolyl-hydroxylases or OAT1/OAT3 inhibitors (probenacid, rifampicin, gemfibrozil, or teriflunomide).
* Unable to comply with study requirements or in the opinion of a healthcare provider or a member of the central study team, not clinically stable to participate in the study.
* Pregnant at time of consent (per subject self-report).
18 Years
ALL
No
Sponsors
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Akebia Therapeutics
INDUSTRY
USRC Kidney Research
NETWORK
Responsible Party
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Locations
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USRC Kidney Research
Lone Tree, Colorado, United States
Nephrology and Hypertension Specialists, PC
Dalton, Georgia, United States
US Renal Care - Gallup
Gallup, New Mexico, United States
Dallas Renal Group
Dallas, Texas, United States
US Renal Care - Live Oak
Live Oak, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Stephanie Brillhart
Role: primary
Martha Block
Role: backup
Geoffrey Block, MD
Role: backup
Stephanie Brillhart
Role: primary
Stephanie Brillhart
Role: primary
Stephanie Brillhart
Role: primary
Stephanie Brillhart
Role: primary
Other Identifiers
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USRC-2024-001
Identifier Type: -
Identifier Source: org_study_id