Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
NCT ID: NCT03054350
Last Updated: 2021-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2016-12-31
2018-01-24
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
TRIPLE
Study Groups
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Vadadustat, Dose 1
Daily oral dose
Vadadustat
Daily oral dose
Vadadustat, Dose 2
Daily oral dose
Vadadustat
Daily oral dose
Vadadustat, Dose 3
Daily oral dose
Vadadustat
Daily oral dose
Placebo
Daily oral dose
Placebo
Daily oral dose
Interventions
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Vadadustat
Daily oral dose
Placebo
Daily oral dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving chronic maintenance hemodialysis for end-stage kidney disease
* Hemoglobin (Hb) \<10.0 grams per deciliter (g/dL)
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
20 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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Aichi, , Japan
Ehime, , Japan
Fukui, , Japan
Hiroshima, , Japan
Hokkaido, , Japan
Hyōgo, , Japan
Ibaraki, , Japan
Kagoshima, , Japan
Kochi, , Japan
Miyagi, , Japan
Nagano, , Japan
Nagasaki, , Japan
Niigata, , Japan
Okinawa, , Japan
Osaka, , Japan
Ōita, , Japan
Saitama, , Japan
Shizuoka, , Japan
Countries
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References
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Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AKB-6548-CI-0022
Identifier Type: -
Identifier Source: org_study_id
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