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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

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABT-719
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring GFR, Acute Kidney Injury, High Risk cardiac surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Reference ID/Investigator# 83739
  • Site Reference ID/Investigator# 87720
  • Site Reference ID/Investigator# 83746
  • Site Reference ID/Investigator# 83733
  • Site Reference ID/Investigator# 89178
  • Site Reference ID/Investigator# 87693
  • Site Reference ID/Investigator# 87717
  • Site Reference ID/Investigator# 89180
  • Site Reference ID/Investigator# 101942
  • Site Reference ID/Investigator# 85917
  • Site Reference ID/Investigator# 83732
  • Site Reference ID/Investigator# 83724
  • Site Reference ID/Investigator# 83745
  • Site Reference ID/Investigator# 83750
  • Site Reference ID/Investigator# 83747
  • Site Reference ID/Investigator# 83744
  • Site Reference ID/Investigator# 85913
  • Site Reference ID/Investigator# 96455
  • Site Reference ID/Investigator# 91253
  • Site Reference ID/Investigator# 93673
  • Site Reference ID/Investigator# 83722
  • Site Reference ID/Investigator# 89176
  • Site Reference ID/Investigator# 83723
  • Site Reference ID/Investigator# 92413
  • Site Reference ID/Investigator# 87733
  • Site Reference ID/Investigator# 83735
  • Site Reference ID/Investigator# 91813
  • Site Reference ID/Investigator# 83738
  • Site Reference ID/Investigator# 91693
  • Site Reference ID/Investigator# 89182
  • Site Reference ID/Investigator# 83734
  • Site Reference ID/Investigator# 83730
  • Site Reference ID/Investigator# 101876
  • Site Reference ID/Investigator# 90614
  • Site Reference ID/Investigator# 83725
  • Site Reference ID/Investigator# 87714
  • Site Reference ID/Investigator# 91814
  • Site Reference ID/Investigator# 87739
  • Site Reference ID/Investigator# 94956
  • Site Reference ID/Investigator# 109295
  • Site Reference ID/Investigator# 94955

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Arm 1 ABT-719 lower dose

Arm 2 ABT-719 intermediate dose

Arm 3 ABT-719 higher dose

Arm 4 placebo

Arm Description

Outcomes

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.

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
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)
Proportion of subjects developing AKI as defined by the Risk, Injury, Failure, Loss, or ESRD (RIFLE) model
Proportion of subjects developing AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) model
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

Full Information

First Posted
January 24, 2013
Last Updated
July 2, 2021
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT01777165
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
GFR, Acute Kidney Injury, High Risk cardiac surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 ABT-719 lower dose
Arm Type
Experimental
Arm Title
Arm 2 ABT-719 intermediate dose
Arm Type
Experimental
Arm Title
Arm 3 ABT-719 higher dose
Arm Type
Experimental
Arm Title
Arm 4 placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ABT-719
Intervention Description
1 arm of ABT-719 higher dose, 1 arm of ABT-719 intermediate dose, and 1 arm ABT-719 lower dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo infusion
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Proportion of subjects developing AKI as defined by the Risk, Injury, Failure, Loss, or ESRD (RIFLE) model
Time Frame
Up through Day 7
Title
Proportion of subjects developing AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) model
Time Frame
Up through Day 7
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Eldred, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 83739
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Site Reference ID/Investigator# 87720
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Site Reference ID/Investigator# 83746
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Site Reference ID/Investigator# 83733
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Site Reference ID/Investigator# 89178
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Site Reference ID/Investigator# 87693
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Site Reference ID/Investigator# 87717
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Site Reference ID/Investigator# 89180
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Site Reference ID/Investigator# 101942
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Site Reference ID/Investigator# 85917
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Site Reference ID/Investigator# 83732
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Site Reference ID/Investigator# 83724
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Site Reference ID/Investigator# 83745
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Site Reference ID/Investigator# 83750
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Site Reference ID/Investigator# 83747
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Site Reference ID/Investigator# 83744
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Site Reference ID/Investigator# 85913
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Site Reference ID/Investigator# 96455
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Site Reference ID/Investigator# 91253
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2315
Country
United States
Facility Name
Site Reference ID/Investigator# 93673
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Site Reference ID/Investigator# 83722
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Site Reference ID/Investigator# 89176
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Site Reference ID/Investigator# 83723
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Site Reference ID/Investigator# 92413
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Site Reference ID/Investigator# 87733
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Site Reference ID/Investigator# 83735
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Site Reference ID/Investigator# 91813
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Site Reference ID/Investigator# 83738
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Site Reference ID/Investigator# 91693
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Site Reference ID/Investigator# 89182
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97447
Country
United States
Facility Name
Site Reference ID/Investigator# 83734
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Site Reference ID/Investigator# 83730
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
Site Reference ID/Investigator# 101876
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Site Reference ID/Investigator# 90614
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Site Reference ID/Investigator# 83725
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Site Reference ID/Investigator# 87714
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Site Reference ID/Investigator# 91814
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Site Reference ID/Investigator# 87739
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Site Reference ID/Investigator# 94956
City
Aarhus N
ZIP/Postal Code
DK-8200
Country
Denmark
Facility Name
Site Reference ID/Investigator# 109295
City
Copenhagen O
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Site Reference ID/Investigator# 94955
City
Odense C
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
27543797
Citation
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.
Results Reference
result

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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

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