A Safety and Efficacy Trial of Multiple Dosing Regimens o... | NCT01777165

ID	Type	Description	Link
2012-003942-33	EudraCT Number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Arm 1 ABT-719 lower dose	Experimental	Drug: ABT-719
Arm 2 ABT-719 intermediate dose	Experimental	Drug: ABT-719
Arm 3 ABT-719 higher dose	Experimental	Drug: ABT-719
Arm 4 placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ABT-719	Drug	1 arm of ABT-719 higher dose, 1 arm of ABT-719 intermediate dose, and 1 arm ABT-719 lower dose	Arm 1 ABT-719 lower dose Arm 2 ABT-719 intermediate dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		Up through Day 7

Secondary Outcomes

Measure	Description	Time Frame
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		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)

Eligibility Module

Eligibility 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

Name	Affiliation	Role
Ann Eldred, MD	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 83739		Danbury	Connecticut	06810	United States
Site Reference ID/Investigator# 87720

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27543797	Result	McCullough PA, Bennett-Guerrero E, Chawla LS, Beaver T, Mehta RL, Molitoris BA, Eldred A, Ball G, Lee HJ, Houser MT, Khan S. ABT-719 for the Prevention of Acute Kidney Injury in Patients Undergoing High-Risk Cardiac Surgery: A Randomized Phase 2b Clinical Trial. J Am Heart Assoc. 2016 Aug 20;5(8):e003549. doi: 10.1161/JAHA.116.003549.

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases