16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis
NCT ID: NCT02260193
Last Updated: 2022-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
94 participants
INTERVENTIONAL
2014-09-10
2015-07-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AKB-6548, starting dose 1
AKB-6548
Starting dose 1. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
AKB-6548, starting dose 2
AKB-6548
Starting dose 2. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
AKB-6548, starting dose 3
AKB-6548
Starting dose 3. Oral dose administered three times weekly for 16 weeks. Dose adjustment based on hemoglobin levels as defined in the protocol.
Interventions
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AKB-6548
Starting dose 1. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
AKB-6548
Starting dose 2. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
AKB-6548
Starting dose 3. Oral dose administered three times weekly for 16 weeks. Dose adjustment based on hemoglobin levels as defined in the protocol.
Eligibility Criteria
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Inclusion Criteria
* Chronic Kidney Disease (CKD) Stage 5 on chronic hemodialysis for at least 3 months
* Anemia secondary to CKD treated with erythropoiesis stimulating agent and intravenous iron
Exclusion Criteria
* Transfusion within 8 weeks prior to Screening
* Alanine transaminase or total bilirubin \>1.25x ULN
* Uncontrolled hypertension
* Class III or IV congestive heart failure
* Myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack within 6 months prior to Screening
18 Years
79 Years
ALL
No
Sponsors
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Akebia Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
Akebia Therapeutics Inc.
Locations
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El Granada, California, United States
Long Beach, California, United States
San Dimas, California, United States
Santa Clarita, California, United States
Whittier, California, United States
Arvada, Colorado, United States
Westminster, Colorado, United States
Naples, Florida, United States
North Miami Beach, Florida, United States
Augusta, Georgia, United States
Astoria, New York, United States
Arlington, Texas, United States
Grand Prairie, Texas, United States
Greenville, Texas, United States
Houston, Texas, United States
Mechanicsville, Virginia, United States
Countries
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Other Identifiers
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AKB-6548-CI-0011
Identifier Type: -
Identifier Source: org_study_id
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