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

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of ABT-719 in patients undergoing high risk major surgery.

Official Title
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A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Major Surgery

Conditions
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Cardiothoracic Surgery, Vascular Surgery

Intervention / Treatment
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* Drug: Placebo
* Drug: ABT-719


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 lower dose ABT-719<br> | Drug: ABT-719<br>* Arm 1 lower dose, arm 2 intermediate dose, arm 3 high dose<br>|
| Experimental: Arm 2 intermediate dose ABT-719<br> | Drug: ABT-719<br>* Arm 1 lower dose, arm 2 intermediate dose, arm 3 high dose<br>|
| Experimental: Arm 3 high dose ABT-719<br> | Drug: ABT-719<br>* Arm 1 lower dose, arm 2 intermediate dose, arm 3 high dose<br>|
| Placebo Comparator: Arm 4 Placebo<br> | Drug: Placebo<br>* Placebo infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) | Comparison between each ABT-719 dose group versus placebo in the mean maximal change from baseline in urine NGAL from Day 0 - Day 7. | Day 0 to Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects that develop composite event at 90 days post surgery | 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. | 90 Day | 
| Proportion of subjects that develop a composite event at 60 days post surgery | 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. | 60 Days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High risk surgery, Acute Kidney Injury