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

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777165
• Other study ID #: M13-796
• Secondary ID: 2012-003942-33
• Status: Completed
• Phase: Phase 2
• Start date: February 2013
• Est. completion date: March 2014

Study information

• Verified date: July 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

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
Placebo infusion

Locations

Country	Name	City	State
Denmark	Site Reference ID/Investigator# 94956	Aarhus N
Denmark	Site Reference ID/Investigator# 109295	Copenhagen O
Denmark	Site Reference ID/Investigator# 94955	Odense C
United States	Site Reference ID/Investigator# 89176	Asheville	North Carolina
United States	Site Reference ID/Investigator# 87693	Atlanta	Georgia
United States	Site Reference ID/Investigator# 87717	Augusta	Georgia
United States	Site Reference ID/Investigator# 83732	Bethesda	Maryland
United States	Site Reference ID/Investigator# 83724	Boston	Massachusetts
United States	Site Reference ID/Investigator# 83745	Boston	Massachusetts
United States	Site Reference ID/Investigator# 90614	Charlottesville	Virginia
United States	Site Reference ID/Investigator# 83735	Cincinnati	Ohio
United States	Site Reference ID/Investigator# 91813	Columbus	Ohio
United States	Site Reference ID/Investigator# 83739	Danbury	Connecticut
United States	Site Reference ID/Investigator# 83723	Durham	North Carolina
United States	Site Reference ID/Investigator# 89180	Fort Wayne	Indiana
United States	Site Reference ID/Investigator# 87720	Gainesville	Florida
United States	Site Reference ID/Investigator# 92413	Gastonia	North Carolina
United States	Site Reference ID/Investigator# 83750	Grand Blanc	Michigan
United States	Site Reference ID/Investigator# 101942	Indianapolis	Indiana
United States	Site Reference ID/Investigator# 83733	Jacksonville	Florida
United States	Site Reference ID/Investigator# 83746	Jacksonville	Florida
United States	Site Reference ID/Investigator# 83730	Knoxville	Tennessee
United States	Site Reference ID/Investigator# 85917	Lexington	Kentucky
United States	Site Reference ID/Investigator# 91814	Madison	Wisconsin
United States	Site Reference ID/Investigator# 101876	Memphis	Tennessee
United States	Site Reference ID/Investigator# 87739	Milwaukee	Wisconsin
United States	Site Reference ID/Investigator# 83722	New York	New York
United States	Site Reference ID/Investigator# 93673	Newark	New Jersey
United States	Site Reference ID/Investigator# 91253	Omaha	Nebraska
United States	Site Reference ID/Investigator# 83747	Petoskey	Michigan
United States	Site Reference ID/Investigator# 83734	Pittsburgh	Pennsylvania
United States	Site Reference ID/Investigator# 91693	Portland	Oregon
United States	Site Reference ID/Investigator# 83725	Richmond	Virginia
United States	Site Reference ID/Investigator# 83744	Royal Oak	Michigan
United States	Site Reference ID/Investigator# 96455	Saint Louis	Missouri
United States	Site Reference ID/Investigator# 85913	Saint Paul	Minnesota
United States	Site Reference ID/Investigator# 89182	Springfield	Oregon
United States	Site Reference ID/Investigator# 87714	Tacoma	Washington
United States	Site Reference ID/Investigator# 89178	Tampa	Florida
United States	Site Reference ID/Investigator# 83738	Toledo	Ohio
United States	Site Reference ID/Investigator# 87733	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Denmark, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Proportion of subjects developing AKI as defined by the Risk, Injury, Failure, Loss, or ESRD (RIFLE) model		Up through Day 7
Secondary	Proportion of subjects developing AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) model		Up through Day 7
Secondary	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