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



Status:Completed
Conditions:Post-Surgical Pain, Hospital
Therapuetic Areas:Musculoskeletal, Other
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:May 2013
End Date:October 2014
Contact:Donna Radjenovich, MS
Email:donna.radjenovich@abbvie.com
Phone:847-938-7909

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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

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


Inclusion Criteria:

- Patients undergoing high risk major surgery (i.e., abdominal surgery, vascular surgery,
cardiothoracic surgery) with baseline chronic kidney disease (stage 3 and 4) and having
diabetes or proteinuria or history of cardiovascular disease

Exclusion Criteria:

- Ongoing or recent history of sepsis

- Has recent documented acute kidney injury.

- Recent history of congestive heart failure

- Subject is scheduled to have a total or partial nephrectomy.
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