SIU School of Medicine

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Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery.

IRB Number

13-712

ClinicalTrials.gov Identifier

NCT01777165

Trial Status

Open for Enrollment
Phase 2

Why is this study being done?

This study is being done to investigate the safety and efficacy of an investigational drug called ABT-719 on patients who are scheduled for a cardiac surgery and have at least one risk factor for developing Acute Kidney Injury (AKI). This study will evaluate the effect of ABT-719 on the prevention of AKI in patients undergoing cardiac surgery.

Who is eligible to participate?

Subjects who are undergoing Cardio Pulmonary Bypass Surgery and have at least one additional risk factor which puts them at a high risk for Acute Kidney Injury.

What is involved?

Subjects participating in this study must have a screening visit to determine if they are eligible for the study. A medical history will be taken and routine blood tests will be done. A pregnancy test will be administered to women of childbearing ptential. If you are eligible you will be randomly assigned to a study group to receive a specific drug dosage or placebo prior to, during and after surgery. Tests and procedures will be performed at Day 0 (surgery) through Day 7, Day 30, Day 60 and Day 90.

How long is the study?

Participation in this study lasts approximately 4 months and include up to 13 study visits to the research center. Up to 8 visits may occur while you are hospitalized.

Who can I contact for additional information?

For questions regarding this study contact Theresa Boley, APN at (217) 545-5000.

Who is the Principal Investigator of this study?

Stephen Hazelrigg, MD

Where is the trial located?

Springfield, Illinois