A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery
NCT ID: NCT01777165
Last Updated: 2021-07-07
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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COMPLETED
PHASE2
240 participants
INTERVENTIONAL
2013-02-28
2014-03-31
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
PREVENTION
QUADRUPLE
Study Groups
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Arm 1 ABT-719 lower dose
ABT-719
1 arm of ABT-719 higher dose, 1 arm of ABT-719 intermediate dose, and 1 arm ABT-719 lower dose
Arm 2 ABT-719 intermediate dose
ABT-719
1 arm of ABT-719 higher dose, 1 arm of ABT-719 intermediate dose, and 1 arm ABT-719 lower dose
Arm 3 ABT-719 higher dose
ABT-719
1 arm of ABT-719 higher dose, 1 arm of ABT-719 intermediate dose, and 1 arm ABT-719 lower dose
Arm 4 placebo
Placebo
Placebo infusion
Interventions
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ABT-719
1 arm of ABT-719 higher dose, 1 arm of ABT-719 intermediate dose, and 1 arm ABT-719 lower dose
Placebo
Placebo infusion
Eligibility Criteria
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Inclusion Criteria
* Subjects must have stable renal function, per Investigator discretion and no known increase in serum creatinine of greater than or equal to 0.3 mg during the preceding 4 weeks.
* Subjects with estimated glomerular filtration rate less than or equal to 60 mL/min/1.73 m2 who require intravascular iodinated contrast within 48 hours of the day of surgery, will only be included if there is no known serum creatinine increase greater than or equal to 0.3 mg.
* Subjects must be undergoing a pre-defined on-pump cardiac surgery meeting one of the following acute kidney injury risk factors:
* Subject is undergoing combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve (valve(s) surgery), or
* Subject is undergoing surgery of more than one cardiac valve (valves surgery), or
* Subject is undergoing surgery of the aortic root or ascending part of the aorta, or
* Subject is undergoing surgery of the aortic root or ascending part of the aorta, combined with coronary artery bypass graft and/or valve(s) surgery, or
* Subject has an estimated glomerular filtration rate greater than or equal to 16 mL/min/1.73 m2 and less than or equal to 59 mL/min/1.73 m2 as determined by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at Screening, and is undergoing coronary artery bypass graft or single valve surgery.
Exclusion Criteria
* Cardiac surgery to be performed without cardiopulmonary bypass.
* Has ongoing sepsis or history of sepsis within the last 2 weeks or untreated diagnosed infection prior to Screening visit. Sepsis is defined as presence of a confirmed pathogen, along with fever or hypothermia, and hypoperfusion or hypotension.
* Has known or documented RIFLE "R" or AKIN "Stage I" within the previous 4 weeks.
* Recently received (within the last 10 weeks) or is anticipated to receive chemotherapy which can interfere with kidney function
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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Ann Eldred, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 83739
Danbury, Connecticut, United States
Site Reference ID/Investigator# 87720
Gainesville, Florida, United States
Site Reference ID/Investigator# 83746
Jacksonville, Florida, United States
Site Reference ID/Investigator# 83733
Jacksonville, Florida, United States
Site Reference ID/Investigator# 89178
Tampa, Florida, United States
Site Reference ID/Investigator# 87693
Atlanta, Georgia, United States
Site Reference ID/Investigator# 87717
Augusta, Georgia, United States
Site Reference ID/Investigator# 89180
Fort Wayne, Indiana, United States
Site Reference ID/Investigator# 101942
Indianapolis, Indiana, United States
Site Reference ID/Investigator# 85917
Lexington, Kentucky, United States
Site Reference ID/Investigator# 83732
Bethesda, Maryland, United States
Site Reference ID/Investigator# 83724
Boston, Massachusetts, United States
Site Reference ID/Investigator# 83745
Boston, Massachusetts, United States
Site Reference ID/Investigator# 83750
Grand Blanc, Michigan, United States
Site Reference ID/Investigator# 83747
Petoskey, Michigan, United States
Site Reference ID/Investigator# 83744
Royal Oak, Michigan, United States
Site Reference ID/Investigator# 85913
Saint Paul, Minnesota, United States
Site Reference ID/Investigator# 96455
St Louis, Missouri, United States
Site Reference ID/Investigator# 91253
Omaha, Nebraska, United States
Site Reference ID/Investigator# 93673
Newark, New Jersey, United States
Site Reference ID/Investigator# 83722
New York, New York, United States
Site Reference ID/Investigator# 89176
Asheville, North Carolina, United States
Site Reference ID/Investigator# 83723
Durham, North Carolina, United States
Site Reference ID/Investigator# 92413
Gastonia, North Carolina, United States
Site Reference ID/Investigator# 87733
Winston-Salem, North Carolina, United States
Site Reference ID/Investigator# 83735
Cincinnati, Ohio, United States
Site Reference ID/Investigator# 91813
Columbus, Ohio, United States
Site Reference ID/Investigator# 83738
Toledo, Ohio, United States
Site Reference ID/Investigator# 91693
Portland, Oregon, United States
Site Reference ID/Investigator# 89182
Springfield, Oregon, United States
Site Reference ID/Investigator# 83734
Pittsburgh, Pennsylvania, United States
Site Reference ID/Investigator# 83730
Knoxville, Tennessee, United States
Site Reference ID/Investigator# 101876
Memphis, Tennessee, United States
Site Reference ID/Investigator# 90614
Charlottesville, Virginia, United States
Site Reference ID/Investigator# 83725
Richmond, Virginia, United States
Site Reference ID/Investigator# 87714
Tacoma, Washington, United States
Site Reference ID/Investigator# 91814
Madison, Wisconsin, United States
Site Reference ID/Investigator# 87739
Milwaukee, Wisconsin, United States
Site Reference ID/Investigator# 94956
Aarhus N, , Denmark
Site Reference ID/Investigator# 109295
Copenhagen O, , Denmark
Site Reference ID/Investigator# 94955
Odense C, , Denmark
Countries
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References
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McCullough PA, Bennett-Guerrero E, Chawla LS, Beaver T, Mehta RL, Molitoris BA, Eldred A, Ball G, Lee HJ, Houser MT, Khan S. ABT-719 for the Prevention of Acute Kidney Injury in Patients Undergoing High-Risk Cardiac Surgery: A Randomized Phase 2b Clinical Trial. J Am Heart Assoc. 2016 Aug 20;5(8):e003549. doi: 10.1161/JAHA.116.003549.
Other Identifiers
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2012-003942-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M13-796
Identifier Type: -
Identifier Source: org_study_id
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