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 - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Heart Surgery

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ 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 ]


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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777165

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Sponsors and Collaborators

AbbVie

Investigators


Study Director:	Ann Eldred, MD	AbbVie

More Information


Responsible Party:	AbbVie
ClinicalTrials.gov Identifier:	NCT01777165 History of Changes
Other Study ID Numbers:	M13-796 2012-003942-33
Study First Received:	January 24, 2013
Last Updated:	March 30, 2015
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 27, 2016