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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01777165
First Posted: January 28, 2013
Last Update Posted: April 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie
  Purpose
This study will evaluate the safety and efficacy of ABT-719 in preventing acute kidney injury in patients undergoing high risk cardiac surgery.

Condition Intervention Phase
Acute Kidney Injury Drug: ABT-719 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • Proportion of subjects developing AKI as defined by the Risk, Injury, Failure, Loss, or ESRD (RIFLE) model [ Time Frame: Up through Day 7 ]
  • Proportion of subjects developing AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) model [ Time Frame: Up through Day 7 ]
  • 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 ]

Enrollment: 240
Study Start Date: February 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 ABT-719 lower dose Drug: ABT-719
1 arm of ABT-719 higher dose, 1 arm of ABT-719 intermediate dose, and 1 arm ABT-719 lower dose
Experimental: Arm 2 ABT-719 intermediate dose Drug: ABT-719
1 arm of ABT-719 higher dose, 1 arm of ABT-719 intermediate dose, and 1 arm ABT-719 lower dose
Experimental: Arm 3 ABT-719 higher dose Drug: ABT-719
1 arm of ABT-719 higher dose, 1 arm of ABT-719 intermediate dose, and 1 arm ABT-719 lower dose
Placebo Comparator: Arm 4 placebo Drug: Placebo
Placebo infusion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777165


  Hide Study Locations
Locations
United States, Connecticut
Site Reference ID/Investigator# 83739
Danbury, Connecticut, United States, 06810
United States, Florida
Site Reference ID/Investigator# 87720
Gainesville, Florida, United States, 32610
Site Reference ID/Investigator# 83746
Jacksonville, Florida, United States, 32207
Site Reference ID/Investigator# 83733
Jacksonville, Florida, United States, 32216
Site Reference ID/Investigator# 89178
Tampa, Florida, United States, 33613
United States, Georgia
Site Reference ID/Investigator# 87693
Atlanta, Georgia, United States, 30322
Site Reference ID/Investigator# 87717
Augusta, Georgia, United States, 30912
United States, Indiana
Site Reference ID/Investigator# 89180
Fort Wayne, Indiana, United States, 46804
Site Reference ID/Investigator# 101942
Indianapolis, Indiana, United States, 46237
United States, Kentucky
Site Reference ID/Investigator# 85917
Lexington, Kentucky, United States, 40536
United States, Maryland
Site Reference ID/Investigator# 83732
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Site Reference ID/Investigator# 83724
Boston, Massachusetts, United States, 02115
Site Reference ID/Investigator# 83745
Boston, Massachusetts, United States, 02135
United States, Michigan
Site Reference ID/Investigator# 83750
Grand Blanc, Michigan, United States, 48439
Site Reference ID/Investigator# 83747
Petoskey, Michigan, United States, 49770
Site Reference ID/Investigator# 83744
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Site Reference ID/Investigator# 85913
St. Paul, Minnesota, United States, 55102
United States, Missouri
Site Reference ID/Investigator# 96455
St. Louis, Missouri, United States, 63131
United States, Nebraska
Site Reference ID/Investigator# 91253
Omaha, Nebraska, United States, 68198-2315
United States, New Jersey
Site Reference ID/Investigator# 93673
Newark, New Jersey, United States, 07102
United States, New York
Site Reference ID/Investigator# 83722
New York, New York, United States, 10032
United States, North Carolina
Site Reference ID/Investigator# 89176
Ashville, North Carolina, United States, 28803
Site Reference ID/Investigator# 83723
Durham, North Carolina, United States, 27710
Site Reference ID/Investigator# 92413
Gastonia, North Carolina, United States, 28054
Site Reference ID/Investigator# 87733
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Site Reference ID/Investigator# 83735
Cincinnati, Ohio, United States, 45219
Site Reference ID/Investigator# 91813
Columbus, Ohio, United States, 43210
Site Reference ID/Investigator# 83738
Toledo, Ohio, United States, 43606
United States, Oregon
Site Reference ID/Investigator# 91693
Portland, Oregon, United States, 97225
Site Reference ID/Investigator# 89182
Springfield, Oregon, United States, 97447
United States, Pennsylvania
Site Reference ID/Investigator# 83734
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Site Reference ID/Investigator# 83730
Knoxville, Tennessee, United States, 37923
Site Reference ID/Investigator# 101876
Memphis, Tennessee, United States, 38120
United States, Virginia
Site Reference ID/Investigator# 90614
Charlottesville, Virginia, United States, 22908
Site Reference ID/Investigator# 83725
Richmond, Virginia, United States, 23225
United States, Washington
Site Reference ID/Investigator# 87714
Tacoma, Washington, United States, 98405
United States, Wisconsin
Site Reference ID/Investigator# 91814
Madison, Wisconsin, United States, 53792
Site Reference ID/Investigator# 87739
Milwaukee, Wisconsin, United States, 53215
Denmark
Site Reference ID/Investigator# 94956
Aarhus N, Denmark, DK-8200
Site Reference ID/Investigator# 109295
Copenhagen O, Denmark, 2100
Site Reference ID/Investigator# 94955
Odense C, Denmark, 5000
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Ann Eldred, MD AbbVie
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01777165     History of Changes
Other Study ID Numbers: M13-796
2012-003942-33 ( EudraCT Number )
First Submitted: January 24, 2013
First Posted: January 28, 2013
Last Update Posted: April 16, 2015
Last Verified: March 2015

Keywords provided by AbbVie:
GFR
Acute Kidney Injury
High Risk cardiac surgery

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases