42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
NCT ID: NCT01381094
Last Updated: 2022-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
93 participants
INTERVENTIONAL
2011-06-15
2012-02-16
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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AKB-6548 240 mg
AKB-6548
oral dose administered once daily for 42 days
AKB-6548 370 mg
AKB-6548
oral dose administered once daily for 42 days
AKB-6548 500 mg
AKB-6548
oral dose administered once daily for 42 days
AKB-6548 630 mg
AKB-6548
oral dose administered once daily for 42 days
Placebo
Placebo
oral Placebo administered once daily for 42 days
Interventions
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AKB-6548
oral dose administered once daily for 42 days
Placebo
oral Placebo administered once daily for 42 days
Eligibility Criteria
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Inclusion Criteria
* Chronic Kidney Disease (eGFR \<60 mL/min), not yet on dialysis
* Hemoglobin (Hgb) ≤ 10.5 g/dL
* Transferring saturation ≥ 20%
* Ferritin ≥ 50 ng/mL
Exclusion Criteria
* Red blood cell transfusion within 12 weeks
* Androgen therapy within the previous 21 days prior to study dosing
* Therapy with any approved or experimental erythropoiesis stimulating agent (ESA) within the 11 weeks prior to the Screening visit
* Participants meeting the criteria of ESA resistance within the previous 4 months
* Individual doses of intravenous iron of greater than 250 mg within the past 21 days
* Aspartate aminotransferase or alanine aminotransferase \>1.8x upper limit of normal (ULN)
* Alkaline phosphatase \>2x ULN
* Total bilirubin \>1.5x ULN
* Uncontrolled hypertension
* New York Heart Association Class III or IV congestive heart failure
* Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to dosing
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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Pine Bluff, Arkansas, United States
Covina, California, United States
Los Angeles, California, United States
Lynwood, California, United States
Riverside, California, United States
San Dimas, California, United States
Whittier, California, United States
Coral Springs, Florida, United States
Lauderdale Lakes, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Augusta, Georgia, United States
Macon, Georgia, United States
Wichita, Kansas, United States
Shreveport, Louisiana, United States
Springfield, Massachusetts, United States
Detroit, Michigan, United States
Pontiac, Michigan, United States
Warren, Michigan, United States
Bethpage, New York, United States
Mineola, New York, United States
Wilmington, North Carolina, United States
Oklahoma City, Oklahoma, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
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.
Martin ER, Smith MT, Maroni BJ, Zuraw QC, deGoma EM. Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage 3 or 4 Chronic Kidney Disease. Am J Nephrol. 2017;45(5):380-388. doi: 10.1159/000464476. Epub 2017 Mar 25.
Other Identifiers
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AKB-6548-CI-0005
Identifier Type: -
Identifier Source: org_study_id
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