QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/3/2019
Start Date:May 25, 2018
End Date:July 2021
Contact:Quark Pharma Clinical Trials
Email:ClinicalTrials@quarkpharma.com
Phone:510-402-4020

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A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery

This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major
Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following
cardiac surgery. Half of the participants will receive QPI-1002 while the other half will
receive placebo.

This is a randomized, double-blind, placebo-controlled, Phase 3 trial to evaluate QPI-1002
versus placebo for the prevention of Major Adverse Kidney Events in subjects at high risk for
acute kidney injury following cardiac surgery. Subjects will be dosed with active drug or
placebo after the completion of cardiovascular surgery.

Key Inclusion Criteria:

- Male or female, age ≥ 18 years old

- At risk for AKI following cardiac surgery on the basis of at least one of the
following pre-operatively assessed risk factors:

- Reduced renal function

- Diabetes with ongoing insulin treatment

- Albuminuria

- Undergoes non-emergent open chest cavity cardiovascular surgeries, with use of
cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest

Key Exclusion Criteria:

- Emergent surgeries, including aortic dissection, and major congenital heart defects

- Undergoes cardiac surgery off CPB for subjects ≥45 years old. (Cardiac surgery off CPB
for subjects <45 years old is allowed.)

- Perioperative or post cardiac surgery, an left ventricular assist device (LVAD) is
inserted or anticipated
We found this trial at
17
sites
94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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Jacksonville, FL
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Dallas, TX
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Durham, North Carolina 27710
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Fort Wayne, Indiana 46804
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Fort Wayne, IN
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Jacksonville, Florida 32207
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Lincoln, Nebraska 68506
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Lincoln, NE
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Los Angeles, California 90033
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Midland, Michigan 48670
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Midland, MI
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Milwaukee, WI
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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Petoskey, MI
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1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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Richmond, VA
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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Washington, District of Columbia
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Washington,
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Westmead, New South Wales 2145
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Westmead,
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