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

NCT01777165 | Completed Phase 2 DMC

• 2 other identifiers: M13-7962012-003942-33
• Study Type: interventional
• Target: 240
• Locations: 2 countries
• Sites: 41

Brief Summary

This study will evaluate the safety and efficacy of ABT-719 in preventing acute kidney injury in patients undergoing high risk cardiac surgery.

Conditions

Acute Kidney Injury

Keywords

GFR; Acute Kidney Injury; High Risk cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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 (5)

• 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)

  Up through Day 60

• Proportion of subjects developing AKI as defined by the Risk, Injury, Failure, Loss, or ESRD (RIFLE) model

  Up through Day 7

• Proportion of subjects developing AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) model

  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

  Up through Day 90

Study Arms (4)

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

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; Arm 3 ABT-719 higher dose

Placebo DRUG

Placebo infusion

Arm 4 placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (41)

Site Reference ID/Investigator# 83739

Danbury, Connecticut, 06810, United States

Location

Site Reference ID/Investigator# 87720

Gainesville, Florida, 32610, United States

Location

Site Reference ID/Investigator# 83746

Jacksonville, Florida, 32207, United States

Location

Site Reference ID/Investigator# 83733

Jacksonville, Florida, 32216, United States

Location

Site Reference ID/Investigator# 89178

Tampa, Florida, 33613, United States

Location

Site Reference ID/Investigator# 87693

Atlanta, Georgia, 30322, United States

Location

Site Reference ID/Investigator# 87717

Augusta, Georgia, 30912, United States

Location

Site Reference ID/Investigator# 89180

Fort Wayne, Indiana, 46804, United States

Location

Site Reference ID/Investigator# 101942

Indianapolis, Indiana, 46237, United States

Location

Site Reference ID/Investigator# 85917

Lexington, Kentucky, 40536, United States

Location

Site Reference ID/Investigator# 83732

Bethesda, Maryland, 20814, United States

Location

Site Reference ID/Investigator# 83724

Boston, Massachusetts, 02115, United States

Location

Site Reference ID/Investigator# 83745

Boston, Massachusetts, 02135, United States

Location

Site Reference ID/Investigator# 83750

Grand Blanc, Michigan, 48439, United States

Location

Site Reference ID/Investigator# 83747

Petoskey, Michigan, 49770, United States

Location

Site Reference ID/Investigator# 83744

Royal Oak, Michigan, 48073, United States

Location

Site Reference ID/Investigator# 85913

Saint Paul, Minnesota, 55102, United States

Location

Site Reference ID/Investigator# 96455

St Louis, Missouri, 63131, United States

Location

Site Reference ID/Investigator# 91253

Omaha, Nebraska, 68198-2315, United States

Location

Site Reference ID/Investigator# 93673

Newark, New Jersey, 07102, United States

Location

Site Reference ID/Investigator# 83722

New York, New York, 10032, United States

Location

Site Reference ID/Investigator# 89176

Asheville, North Carolina, 28803, United States

Location

Site Reference ID/Investigator# 83723

Durham, North Carolina, 27710, United States

Location

Site Reference ID/Investigator# 92413

Gastonia, North Carolina, 28054, United States

Location

Site Reference ID/Investigator# 87733

Winston-Salem, North Carolina, 27103, United States

Location

Site Reference ID/Investigator# 83735

Cincinnati, Ohio, 45219, United States

Location

Site Reference ID/Investigator# 91813

Columbus, Ohio, 43210, United States

Location

Site Reference ID/Investigator# 83738

Toledo, Ohio, 43606, United States

Location

Site Reference ID/Investigator# 91693

Portland, Oregon, 97225, United States

Location

Site Reference ID/Investigator# 89182

Springfield, Oregon, 97447, United States

Location

Site Reference ID/Investigator# 83734

Pittsburgh, Pennsylvania, 15232, United States

Location

Site Reference ID/Investigator# 83730

Knoxville, Tennessee, 37923, United States

Location

Site Reference ID/Investigator# 101876

Memphis, Tennessee, 38120, United States

Location

Site Reference ID/Investigator# 90614

Charlottesville, Virginia, 22908, United States

Location

Site Reference ID/Investigator# 83725

Richmond, Virginia, 23225, United States

Location

Site Reference ID/Investigator# 87714

Tacoma, Washington, 98405, United States

Location

Site Reference ID/Investigator# 91814

Madison, Wisconsin, 53792, United States

Location

Site Reference ID/Investigator# 87739

Milwaukee, Wisconsin, 53215, United States

Location

Site Reference ID/Investigator# 94956

Aarhus N, DK-8200, Denmark

Location

Site Reference ID/Investigator# 109295

Copenhagen O, 2100, Denmark

Location

Site Reference ID/Investigator# 94955

Odense C, 5000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 27543797 RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

ABT 719

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ann Eldred, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 28, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

DK (3); US (38)