This study will evaluate the safety and efficacy of ABT-719 in preventing acute kidney injury in patients undergoing high risk cardiac surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
240
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.
Time frame: 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 estimated glomerular filtration rate or measured glomerular filtration rate
Time frame: 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 serum creatinine based estimated glomerular filtration rate (GFR)
Time frame: Up through Day 60
Proportion of subjects developing AKI as defined by the Risk, Injury, Failure, Loss, or ESRD (RIFLE) model
Time frame: Up through Day 7
Proportion of subjects developing AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) model
Time frame: 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
Time frame: Up through Day 90
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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
...and 31 more locations