Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
NCT ID: NCT03242967
Last Updated: 2018-11-05
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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WITHDRAWN
PHASE3
INTERVENTIONAL
2017-08-31
2018-02-12
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
Oral tablet
Vadadustat
Oral tablet
Darbepoetin alfa
subcutaneous or intravenous
Darbepoetin alfa
subcutaneous or intravenous
Interventions
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Vadadustat
Oral tablet
Darbepoetin alfa
subcutaneous or intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving chronic maintenance in-center hemodialysis (3 times per week) for end-stage kidney disease
* Currently maintained on ESA therapy
* Mean screening Hb between 8.0 and 11.0 g/dL (inclusive)
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
Northridge, California, United States
Countries
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Other Identifiers
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AKB-6548-CI-0023
Identifier Type: -
Identifier Source: org_study_id
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