20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
NCT ID: NCT01906489
Last Updated: 2022-07-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
210 participants
INTERVENTIONAL
2013-07-23
2014-09-03
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
AKB-6548
Oral dose administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Placebo
Placebo
Oral Placebo administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Interventions
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AKB-6548
Oral dose administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Placebo
Oral Placebo administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Eligibility Criteria
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Inclusion Criteria
* Chronic Kidney Disease with a GFR category of G3a-G5 and not yet on dialysis
* eGFR ≥ 10 and ≤ 65 mL/minute/1.73 m2
* Anemia secondary to CKD with an ESA status and a Screening HGB as per protocol
* Iron replete with ferritin and TSAT levels as defined per protocol
Exclusion Criteria
* Red blood cell transfusion within 11 weeks prior to the Screening visit
* Androgen therapy within the previous 21 days prior to the Screening visit
* Intravenous iron within the past 4 weeks prior to the Screening visit
* AST or ALT \>1.8x ULN, alkaline phosphatase \>2x ULN, or total bilirubin \>1.5x ULN
* Screening ECG with QTc \> 500 msec
* Uncontrolled hypertension
* Class III or IV congestive heart failure
* Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to the Screening visit
18 Years
82 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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Glendale, Arizona, United States
Tucson, Arizona, United States
Azusa, California, United States
Chula Vista, California, United States
Downey, California, United States
El Centro, California, United States
La Mesa, California, United States
Long Beach, California, United States
Riverside, California, United States
Sacramento, California, United States
San Diego, California, United States
Arvada, Colorado, United States
Westminster, Colorado, United States
Lauderdale Lakes, Florida, United States
Port Charlotte, Florida, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Macon, Georgia, United States
Meridian, Idaho, United States
Evergreen Park, Illinois, United States
Lafayette, Louisiana, United States
Shreveport, Louisiana, United States
Detroit, Michigan, United States
Lansing, Michigan, United States
Petoskey, Michigan, United States
Pontiac, Michigan, United States
Farmington, Missouri, United States
Kansas City, Missouri, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
Flushing, New York, United States
Mineola, New York, United States
New Rochelle, New York, United States
Rosedale, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Rocky Mount, North Carolina, United States
Wilmington, North Carolina, United States
Cincinnati, Ohio, United States
Columbia, South Carolina, United States
Knoxville, Tennessee, United States
Arlington, Texas, United States
Austin, Texas, United States
Edinburg, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
St. George, Utah, 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.
Pergola PE, Spinowitz BS, Hartman CS, Maroni BJ, Haase VH. Vadadustat, a novel oral HIF stabilizer, provides effective anemia treatment in nondialysis-dependent chronic kidney disease. Kidney Int. 2016 Nov;90(5):1115-1122. doi: 10.1016/j.kint.2016.07.019. Epub 2016 Sep 17.
Other Identifiers
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AKB-6548-CI-0007
Identifier Type: -
Identifier Source: org_study_id
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