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

Phase 2

Completed

Conditions: Acute Kidney Injury

Interventions: Drug: ABT-719
Drug: Placebo

Registration Number: NCT01777165

Lead Sponsor: AbbVie

Brief Summary: This study will evaluate the safety and efficacy of ABT-719 in preventing acute kidney injury in patients undergoing high risk cardiac surgery.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 240

Inclusion Criteria

Subject must be male or female, age greater than or equal to 18 years old.
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

Has an eGFR less than or equal to 15 mL/min/1.73 m2.
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 ABT-719 lower dose	ABT-719	-
Arm 4 placebo	Placebo	-
Arm 2 ABT-719 intermediate dose	ABT-719	-
Arm 3 ABT-719 higher dose	ABT-719	-

Primary Outcome Measures

Name	Time	Method
Number of patients developing acute kidney injury based on the Acute Kidney Injury Network (AKIN) scoring criteria by comparing the ABT-719 dose groups versus placebo group.	Up through Day 7

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects developing AKI as defined by the Risk, Injury, Failure, Loss, or ESRD (RIFLE) model	Up through Day 7
Proportion of subjects developing at least one of the composite events: death, needing renal replacement therapy, or having greater than or equal to 25 percent reduction in serum creatinine based estimated glomerular filtration rate (GFR)	Up through Day 60
Proportion of subjects developing AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) model	Up through Day 7
Changes from baseline (defined as within 24 hours of day 0) in serum creatinine (SCr) and S-Cystatin C at all study visits from baseline to Day 90	Up through Day 90
Proportion of subjects developing at least one of the composite events: death, needing renal replacement therapy, or having greater than or equal to 25 percent reduction in estimated glomerular filtration rate or measured glomerular filtration rate	Up through Day 90

Trial Locations

Locations (41): Site Reference ID/Investigator# 87720
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Gainesville, Florida, United States
Site Reference ID/Investigator# 83746
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Jacksonville, Florida, United States
Site Reference ID/Investigator# 83733
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Jacksonville, Florida, United States
Site Reference ID/Investigator# 87693
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Atlanta, Georgia, United States
Site Reference ID/Investigator# 87717
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Augusta, Georgia, United States
Site Reference ID/Investigator# 83747
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Petoskey, Michigan, United States
Site Reference ID/Investigator# 89180
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Fort Wayne, Indiana, United States
Site Reference ID/Investigator# 85917
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Lexington, Kentucky, United States
Site Reference ID/Investigator# 83750
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Grand Blanc, Michigan, United States
Site Reference ID/Investigator# 83744
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Royal Oak, Michigan, United States
Site Reference ID/Investigator# 85913
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Saint Paul, Minnesota, United States
Site Reference ID/Investigator# 96455
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Saint Louis, Missouri, United States
Site Reference ID/Investigator# 92413
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Gastonia, North Carolina, United States
Site Reference ID/Investigator# 89176
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Asheville, North Carolina, United States
Site Reference ID/Investigator# 91813
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Columbus, Ohio, United States
Site Reference ID/Investigator# 83722
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New York, New York, United States
Site Reference ID/Investigator# 83738
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Toledo, Ohio, United States
Site Reference ID/Investigator# 89182
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Springfield, Oregon, United States
Site Reference ID/Investigator# 83734
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Pittsburgh, Pennsylvania, United States
Site Reference ID/Investigator# 101876
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Memphis, Tennessee, United States
Site Reference ID/Investigator# 83730
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Knoxville, Tennessee, United States
Site Reference ID/Investigator# 83725
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Richmond, Virginia, United States
Site Reference ID/Investigator# 90614
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Charlottesville, Virginia, United States
Site Reference ID/Investigator# 91814
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Madison, Wisconsin, United States
Site Reference ID/Investigator# 87714
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Tacoma, Washington, United States
Site Reference ID/Investigator# 94955
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Odense C, Denmark
Site Reference ID/Investigator# 94956
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Aarhus N, Denmark
Site Reference ID/Investigator# 109295
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Copenhagen O, Denmark
Site Reference ID/Investigator# 101942
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Indianapolis, Indiana, United States
Site Reference ID/Investigator# 83724
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Boston, Massachusetts, United States
Site Reference ID/Investigator# 83745
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Boston, Massachusetts, United States
Site Reference ID/Investigator# 83723
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Durham, North Carolina, United States
Site Reference ID/Investigator# 83735
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Cincinnati, Ohio, United States
Site Reference ID/Investigator# 91693
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Portland, Oregon, United States
Site Reference ID/Investigator# 83739
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Danbury, Connecticut, United States
Site Reference ID/Investigator# 93673
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Newark, New Jersey, United States
Site Reference ID/Investigator# 89178
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Tampa, Florida, United States
Site Reference ID/Investigator# 83732
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Bethesda, Maryland, United States
Site Reference ID/Investigator# 91253
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Omaha, Nebraska, United States
Site Reference ID/Investigator# 87733
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Winston-Salem, North Carolina, United States
Site Reference ID/Investigator# 87739
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Milwaukee, Wisconsin, United States