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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005710-19 | EudraCT Number |
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Topline results from study M13-796 showed an overall lack of efficacy. There were no safety concerns.
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This study will evaluate the safety and efficacy of ABT-719 in patients undergoing high risk major surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 lower dose ABT-719 | Experimental |
| |
| Arm 2 intermediate dose ABT-719 | Experimental |
| |
| Arm 3 high dose ABT-719 | Experimental |
| |
| Arm 4 Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo infusion |
| |
| ABT-719 |
| 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 |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Eldred, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 96295 | Gainesville | Florida | 32610 | United States | ||
| Site Reference ID/Investigator# 96778 |
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| Drug |
Arm 1 lower dose, arm 2 intermediate dose, arm 3 high dose |
|
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 |
| Jacksonville |
| Florida |
| 32207 |
| United States |
| Site Reference ID/Investigator# 96301 | Tampa | Florida | 33613 | United States |
| Site Reference ID/Investigator# 96302 | Fort Wayne | Indiana | 46804 | United States |
| Site Reference ID/Investigator# 101961 | Indianapolis | Indiana | 46237 | United States |
| Site Reference ID/Investigator# 103356 | Boston | Massachusetts | 02115 | United States |
| Site Reference ID/Investigator# 96303 | Boston | Massachusetts | 02135 | United States |
| Site Reference ID/Investigator# 96997 | Grand Blanc | Michigan | 48439 | United States |
| Site Reference ID/Investigator# 97878 | Petoskey | Michigan | 49770 | United States |
| Site Reference ID/Investigator# 99377 | Royal Oak | Michigan | 48073 | United States |
| Site Reference ID/Investigator# 99317 | West Orange | New Jersey | 07052 | United States |
| Site Reference ID/Investigator# 96996 | New York | New York | 10032 | United States |
| Site Reference ID/Investigator# 96296 | Durham | North Carolina | 27710 | United States |
| Site Reference ID/Investigator# 102020 | Cleveland | Ohio | 44195 | United States |
| Site Reference ID/Investigator# 103355 | Columbus | Ohio | 43210 | United States |
| Site Reference ID/Investigator# 97556 | Pittsburgh | Pennsylvania | 15232 | United States |
| Site Reference ID/Investigator# 103316 | Providence | Rhode Island | 02903 | United States |
| Site Reference ID/Investigator# 102019 | Memphis | Tennessee | 38120 | United States |
| Site Reference ID/Investigator# 108255 | Charlottesville | Virginia | 22908 | United States |
| Site Reference ID/Investigator# 96300 | Milwaukee | Wisconsin | 53215 | United States |
| Site Reference ID/Investigator# 105755 | Aarhus N | 8200 | Denmark |
| Site Reference ID/Investigator# 105757 | Kolding | 6000 | Denmark |
| Site Reference ID/Investigator# 105756 | Odense C | 5000 | Denmark |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C093440 | ABT 719 |
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