Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)
NCT ID: NCT03054337
Last Updated: 2021-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
51 participants
INTERVENTIONAL
2016-10-31
2017-08-28
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
QUADRUPLE
Study Groups
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Vadadustat, Dose 1
Daily oral dose
Vadadustat
Vadadustat, Dose 2
Daily oral dose
Vadadustat
Vadadustat, Dose 3
Daily oral dose
Vadadustat
Placebo
Daily oral dose
Placebo
Interventions
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Vadadustat
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of chronic kidney disease (CKD) based on an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 meters squared (mL/min/1.73 m\^2)
* Hemoglobin (Hb) ≤10.5 grams per deciliter (g/dL)
* Not currently being treated with dialysis and not expected to start dialysis within 3 months of 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
* Intravenous iron within 4 weeks prior to or during screening
* Any use of erythropoiesis-stimulating agents within 6 weeks prior to or during screening
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
Chiba, , Japan
Ehime, , Japan
Gunma, , Japan
Hiroshima, , Japan
Hokkaido, , Japan
Hyōgo, , Japan
Ibaraki, , Japan
Kanagawa, , Japan
Nagano, , Japan
Nara, , Japan
Niigata, , Japan
Okayama, , Japan
Okinawa, , Japan
Osaka, , Japan
Ōita, , Japan
Shiga, , Japan
Tokushima, , 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-0021
Identifier Type: -
Identifier Source: org_study_id
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