A 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
July 2, 2021 updated by: AbbVie
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 Cardiac Surgery
This study will evaluate the safety and efficacy of ABT-719 in preventing acute kidney injury in patients undergoing high risk cardiac surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aarhus N, Denmark, DK-8200
- Site Reference ID/Investigator# 94956
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Copenhagen O, Denmark, 2100
- Site Reference ID/Investigator# 109295
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Odense C, Denmark, 5000
- Site Reference ID/Investigator# 94955
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Connecticut
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Danbury, Connecticut, United States, 06810
- Site Reference ID/Investigator# 83739
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Florida
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Gainesville, Florida, United States, 32610
- Site Reference ID/Investigator# 87720
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Jacksonville, Florida, United States, 32207
- Site Reference ID/Investigator# 83746
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Jacksonville, Florida, United States, 32216
- Site Reference ID/Investigator# 83733
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Tampa, Florida, United States, 33613
- Site Reference ID/Investigator# 89178
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Georgia
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Atlanta, Georgia, United States, 30322
- Site Reference ID/Investigator# 87693
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Augusta, Georgia, United States, 30912
- Site Reference ID/Investigator# 87717
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Indiana
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Fort Wayne, Indiana, United States, 46804
- Site Reference ID/Investigator# 89180
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Indianapolis, Indiana, United States, 46237
- Site Reference ID/Investigator# 101942
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Kentucky
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Lexington, Kentucky, United States, 40536
- Site Reference ID/Investigator# 85917
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Maryland
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Bethesda, Maryland, United States, 20814
- Site Reference ID/Investigator# 83732
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Site Reference ID/Investigator# 83724
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Boston, Massachusetts, United States, 02135
- Site Reference ID/Investigator# 83745
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Michigan
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Grand Blanc, Michigan, United States, 48439
- Site Reference ID/Investigator# 83750
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Petoskey, Michigan, United States, 49770
- Site Reference ID/Investigator# 83747
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Royal Oak, Michigan, United States, 48073
- Site Reference ID/Investigator# 83744
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Minnesota
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Saint Paul, Minnesota, United States, 55102
- Site Reference ID/Investigator# 85913
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Missouri
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Saint Louis, Missouri, United States, 63131
- Site Reference ID/Investigator# 96455
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Nebraska
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Omaha, Nebraska, United States, 68198-2315
- Site Reference ID/Investigator# 91253
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New Jersey
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Newark, New Jersey, United States, 07102
- Site Reference ID/Investigator# 93673
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New York
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New York, New York, United States, 10032
- Site Reference ID/Investigator# 83722
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North Carolina
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Asheville, North Carolina, United States, 28803
- Site Reference ID/Investigator# 89176
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Durham, North Carolina, United States, 27710
- Site Reference ID/Investigator# 83723
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Gastonia, North Carolina, United States, 28054
- Site Reference ID/Investigator# 92413
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Winston-Salem, North Carolina, United States, 27103
- Site Reference ID/Investigator# 87733
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Ohio
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Cincinnati, Ohio, United States, 45219
- Site Reference ID/Investigator# 83735
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Columbus, Ohio, United States, 43210
- Site Reference ID/Investigator# 91813
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Toledo, Ohio, United States, 43606
- Site Reference ID/Investigator# 83738
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Oregon
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Portland, Oregon, United States, 97225
- Site Reference ID/Investigator# 91693
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Springfield, Oregon, United States, 97447
- Site Reference ID/Investigator# 89182
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- Site Reference ID/Investigator# 83734
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Tennessee
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Knoxville, Tennessee, United States, 37923
- Site Reference ID/Investigator# 83730
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Memphis, Tennessee, United States, 38120
- Site Reference ID/Investigator# 101876
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Virginia
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Charlottesville, Virginia, United States, 22908
- Site Reference ID/Investigator# 90614
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Richmond, Virginia, United States, 23225
- Site Reference ID/Investigator# 83725
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Washington
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Tacoma, Washington, United States, 98405
- Site Reference ID/Investigator# 87714
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Wisconsin
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Madison, Wisconsin, United States, 53792
- Site Reference ID/Investigator# 91814
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Milwaukee, Wisconsin, United States, 53215
- Site Reference ID/Investigator# 87739
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject must be male or female, age greater than or equal to 18 years old.
- Subjects must have stable renal function, per Investigator discretion and no known increase in serum creatinine of greater than or equal to 0.3 mg during the preceding 4 weeks.
- Subjects with estimated glomerular filtration rate less than or equal to 60 mL/min/1.73 m2 who require intravascular iodinated contrast within 48 hours of the day of surgery, will only be included if there is no known serum creatinine increase greater than or equal to 0.3 mg.
- Subjects must be undergoing a pre-defined on-pump cardiac surgery meeting one of the following acute kidney injury risk factors:
- Subject is undergoing combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve (valve(s) surgery), or
- Subject is undergoing surgery of more than one cardiac valve (valves surgery), or
- Subject is undergoing surgery of the aortic root or ascending part of the aorta, or
- Subject is undergoing surgery of the aortic root or ascending part of the aorta, combined with coronary artery bypass graft and/or valve(s) surgery, or
- Subject has an estimated glomerular filtration rate greater than or equal to 16 mL/min/1.73 m2 and less than or equal to 59 mL/min/1.73 m2 as determined by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at Screening, and is undergoing coronary artery bypass graft or single valve surgery.
Exclusion Criteria:
- Has an eGFR less than or equal to 15 mL/min/1.73 m2.
- Cardiac surgery to be performed without cardiopulmonary bypass.
- Has ongoing sepsis or history of sepsis within the last 2 weeks or untreated diagnosed infection prior to Screening visit. Sepsis is defined as presence of a confirmed pathogen, along with fever or hypothermia, and hypoperfusion or hypotension.
- Has known or documented RIFLE "R" or AKIN "Stage I" within the previous 4 weeks.
- Recently received (within the last 10 weeks) or is anticipated to receive chemotherapy which can interfere with kidney function
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Arm 1 ABT-719 lower dose
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1 arm of ABT-719 higher dose, 1 arm of ABT-719 intermediate dose, and 1 arm ABT-719 lower dose
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EXPERIMENTAL: Arm 2 ABT-719 intermediate dose
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1 arm of ABT-719 higher dose, 1 arm of ABT-719 intermediate dose, and 1 arm ABT-719 lower dose
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EXPERIMENTAL: Arm 3 ABT-719 higher dose
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1 arm of ABT-719 higher dose, 1 arm of ABT-719 intermediate dose, and 1 arm ABT-719 lower dose
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PLACEBO_COMPARATOR: Arm 4 placebo
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Placebo infusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Number of patients developing acute kidney injury based on the Acute Kidney Injury Network (AKIN) scoring criteria by comparing the ABT-719 dose groups versus placebo group.
Time Frame: Up through Day 7
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Up through Day 7
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Proportion of subjects developing at least one of the composite events: death, needing renal replacement therapy, or having greater than or equal to 25 percent reduction in estimated glomerular filtration rate or measured glomerular filtration rate
Time Frame: Up through Day 90
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Up through Day 90
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Proportion of subjects developing at least one of the composite events: death, needing renal replacement therapy, or having greater than or equal to 25 percent reduction in serum creatinine based estimated glomerular filtration rate (GFR)
Time Frame: Up through Day 60
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Up through Day 60
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Proportion of subjects developing AKI as defined by the Risk, Injury, Failure, Loss, or ESRD (RIFLE) model
Time Frame: Up through Day 7
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Up through Day 7
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Proportion of subjects developing AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) model
Time Frame: Up through Day 7
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Up through Day 7
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Changes from baseline (defined as within 24 hours of day 0) in serum creatinine (SCr) and S-Cystatin C at all study visits from baseline to Day 90
Time Frame: Up through Day 90
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Up through Day 90
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (ACTUAL)
March 1, 2014
Study Completion (ACTUAL)
March 1, 2014
Study Registration Dates
First Submitted
January 24, 2013
First Submitted That Met QC Criteria
January 24, 2013
First Posted (ESTIMATE)
January 28, 2013
Study Record Updates
Last Update Posted (ACTUAL)
July 7, 2021
Last Update Submitted That Met QC Criteria
July 2, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M13-796
- 2012-003942-33 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.