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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:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01777165
First received: January 24, 2013
Last updated: April 3, 2014
Last verified: April 2014

January 24, 2013
April 3, 2014
February 2013
March 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01777165 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects developing AKI as defined by the Risk, Injury, Failure, Loss, or ESRD (RIFLE) model [ Time Frame: Up through Day 7 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects developing AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) model [ Time Frame: Up through Day 7 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Acute Kidney Injury
  • Drug: ABT-719
    1 arm of ABT-719 higher dose, 1 arm of ABT-719 intermediate dose, and 1 arm ABT-719 lower dose
  • Drug: Placebo
    Placebo infusion
  • Experimental: Arm 1 ABT-719 lower dose
    Intervention: Drug: ABT-719
  • Experimental: Arm 2 ABT-719 intermediate dose
    Intervention: Drug: ABT-719
  • Experimental: Arm 3 ABT-719 higher dose
    Intervention: Drug: ABT-719
  • Placebo Comparator: Arm 4 placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Denmark
 
NCT01777165
M13-796, 2012-003942-33
Yes
AbbVie
AbbVie
Not Provided
Study Director: Ann Eldred, MD AbbVie
AbbVie
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP