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

AbbVie

Status and phase: Completed; Phase 2

Conditions: Acute Kidney Injury

Treatments: Drug: Placebo; Drug: ABT-719

Study type: Interventional

Funder types: Industry

Identifiers

NCT01777165

2012-003942-33 (EudraCT Number)

M13-796

Details and patient eligibility

About

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

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 4 patient groups, including a placebo group

Arm 1 ABT-719 lower dose

Experimental group

Treatment:

Drug: ABT-719

Arm 2 ABT-719 intermediate dose

Experimental group

Treatment:

Drug: ABT-719

Arm 3 ABT-719 higher dose

Experimental group

Treatment:

Drug: ABT-719

Arm 4 placebo

Placebo Comparator group

Treatment:

Drug: Placebo