A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Surgery
- Conditions
- Cardiothoracic SurgeryVascular Surgery
- Interventions
- Drug: Placebo
- Registration Number
- NCT01897519
- Lead Sponsor
- AbbVie
- Brief Summary
This study will evaluate the safety and efficacy of ABT-719 in patients undergoing high risk major surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 56
- Patients undergoing high risk major surgery in subjects with cardiovascular disease who are at risk of AKI.
- Ongoing or recent history of sepsis
- Has recent documented acute kidney injury.
- Subject is scheduled to have a total or partial nephrectomy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 lower dose ABT-719 ABT-719 - Arm 2 intermediate dose ABT-719 ABT-719 - Arm 4 Placebo Placebo - Arm 3 high dose ABT-719 ABT-719 -
- Primary Outcome Measures
Name Time Method Change in urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) Day 0 to Day 7 Comparison between each ABT-719 dose group versus placebo in the mean maximal change from baseline in urine NGAL from Day 0 - Day 7.
- Secondary Outcome Measures
Name Time Method Proportion of subjects that develop composite event at 90 days post surgery 90 Day Develop at least one of the composite events: death, needing renal replacement therapy during the 90-day post operative period, or having a greater than 25% reduction in estimated or measured glomerular filtration rate.
Proportion of subjects that develop a composite event at 60 days post surgery 60 Days Develop at least one of the composite events: death, needing renal replacement therapy during the 60-day post operative period, or having a greater than 25% reduction in estimated or measured glomerular filtration rate.
Proportion of subjects that develop the Acute Kidney Injury Network (AKIN) scoring criteria Day 7 Proportion of subjects that develop the Kidney Disease Improving Global Outcomes (KDIGO) scoring criteria Day 7
Trial Locations
- Locations (23)
Site Reference ID/Investigator# 103356
🇺🇸Boston, Massachusetts, United States
Site Reference ID/Investigator# 102020
🇺🇸Cleveland, Ohio, United States
Site Reference ID/Investigator# 103355
🇺🇸Columbus, Ohio, United States
Site Reference ID/Investigator# 97556
🇺🇸Pittsburgh, Pennsylvania, United States
Site Reference ID/Investigator# 96303
🇺🇸Boston, Massachusetts, United States
Site Reference ID/Investigator# 99377
🇺🇸Royal Oak, Michigan, United States
Site Reference ID/Investigator# 102019
🇺🇸Memphis, Tennessee, United States
Site Reference ID/Investigator# 108255
🇺🇸Charlottesville, Virginia, United States
Site Reference ID/Investigator# 96996
🇺🇸New York, New York, United States
Site Reference ID/Investigator# 97878
🇺🇸Petoskey, Michigan, United States
Site Reference ID/Investigator# 96997
🇺🇸Grand Blanc, Michigan, United States
Site Reference ID/Investigator# 96301
🇺🇸Tampa, Florida, United States
Site Reference ID/Investigator# 103316
🇺🇸Providence, Rhode Island, United States
Site Reference ID/Investigator# 96302
🇺🇸Fort Wayne, Indiana, United States
Site Reference ID/Investigator# 96295
🇺🇸Gainesville, Florida, United States
Site Reference ID/Investigator# 101961
🇺🇸Indianapolis, Indiana, United States
Site Reference ID/Investigator# 96778
🇺🇸Jacksonville, Florida, United States
Site Reference ID/Investigator# 96296
🇺🇸Durham, North Carolina, United States
Site Reference ID/Investigator# 96300
🇺🇸Milwaukee, Wisconsin, United States
Site Reference ID/Investigator# 99317
🇺🇸West Orange, New Jersey, United States
Site Reference ID/Investigator# 105755
🇩🇰Aarhus N, Denmark
Site Reference ID/Investigator# 105757
🇩🇰Kolding, Denmark
Site Reference ID/Investigator# 105756
🇩🇰Odense C, Denmark