Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents
NCT ID: NCT03140722
Last Updated: 2021-02-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
2 participants
INTERVENTIONAL
2017-05-02
2018-03-21
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 daily oral dose, adjustable based on Hb level
vadadustat
vadadustat
epoetin alfa
Epoetin alfa, dose adjustable based on Hb level, as clinically indicated throughout the study
epoetin alfa
epoetin alfa
Interventions
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vadadustat
vadadustat
epoetin alfa
epoetin alfa
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving chronic maintenance hemodialysis for end-stage kidney disease
* Currently receiving epoetin alfa for anemia
* Hb between 8.5 and 10.0 g/dL during screening
Exclusion Criteria
* Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
* Red blood cell transfusion within 4 weeks prior to or during screening
* Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation
18 Years
ALL
No
Sponsors
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Akebia Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Akebia Therapeutics
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Research Site
Bakersfield, California, United States
Research Site
Elk Grove, California, United States
Research Site
Encino, California, United States
Research Site
Escondido, California, United States
Research Site
Lynwood, California, United States
Research Site
San Diego, California, United States
Research Site
San Luis Obispo, California, United States
Research Site
Waterbury, Connecticut, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Statesboro, Georgia, United States
Research Site
Detroit, Michigan, United States
Research Site
The Bronx, New York, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
El Paso, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Newport News, Virginia, United States
Research Site
Norfolk, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AKB-6548-CI-0018
Identifier Type: -
Identifier Source: org_study_id
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