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

Phase 2

Terminated

• Conditions: Cardiothoracic Surgery; Vascular Surgery
• Interventions: Drug: ABT-719; 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

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-12
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-05
• Last Update Posted: 2014-06-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Patients undergoing high risk major surgery in subjects with cardiovascular disease who are at risk of AKI.

Exclusion Criteria

• 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# 96295; 🇺🇸 Gainesville, Florida, United States

Site Reference ID/Investigator# 96778; 🇺🇸 Jacksonville, Florida, United States

Site Reference ID/Investigator# 96301; 🇺🇸 Tampa, Florida, United States

Site Reference ID/Investigator# 96302; 🇺🇸 Fort Wayne, Indiana, United States

Site Reference ID/Investigator# 101961; 🇺🇸 Indianapolis, Indiana, United States

Site Reference ID/Investigator# 103356; 🇺🇸 Boston, Massachusetts, United States

Site Reference ID/Investigator# 96303; 🇺🇸 Boston, Massachusetts, United States

Site Reference ID/Investigator# 96997; 🇺🇸 Grand Blanc, Michigan, United States

Site Reference ID/Investigator# 97878; 🇺🇸 Petoskey, Michigan, United States

Site Reference ID/Investigator# 99377; 🇺🇸 Royal Oak, Michigan, United States

Scroll for more (13 remaining)