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

July 2, 2021 updated by: AbbVie

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, DK-8200
        • Site Reference ID/Investigator# 94956
      • Copenhagen O, Denmark, 2100
        • Site Reference ID/Investigator# 109295
      • Odense C, Denmark, 5000
        • Site Reference ID/Investigator# 94955
  • United States
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Site Reference ID/Investigator# 83739
    • Florida
      • Gainesville, Florida, United States, 32610
        • Site Reference ID/Investigator# 87720
      • Jacksonville, Florida, United States, 32207
        • Site Reference ID/Investigator# 83746
      • Jacksonville, Florida, United States, 32216
        • Site Reference ID/Investigator# 83733
      • Tampa, Florida, United States, 33613
        • Site Reference ID/Investigator# 89178
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Site Reference ID/Investigator# 87693
      • Augusta, Georgia, United States, 30912
        • Site Reference ID/Investigator# 87717
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Site Reference ID/Investigator# 89180
      • Indianapolis, Indiana, United States, 46237
        • Site Reference ID/Investigator# 101942
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Site Reference ID/Investigator# 85917
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Site Reference ID/Investigator# 83732
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Site Reference ID/Investigator# 83724
      • Boston, Massachusetts, United States, 02135
        • Site Reference ID/Investigator# 83745
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Site Reference ID/Investigator# 83750
      • Petoskey, Michigan, United States, 49770
        • Site Reference ID/Investigator# 83747
      • Royal Oak, Michigan, United States, 48073
        • Site Reference ID/Investigator# 83744
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • Site Reference ID/Investigator# 85913
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • Site Reference ID/Investigator# 96455
    • Nebraska
      • Omaha, Nebraska, United States, 68198-2315
        • Site Reference ID/Investigator# 91253
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Site Reference ID/Investigator# 93673
    • New York
      • New York, New York, United States, 10032
        • Site Reference ID/Investigator# 83722
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Site Reference ID/Investigator# 89176
      • Durham, North Carolina, United States, 27710
        • Site Reference ID/Investigator# 83723
      • Gastonia, North Carolina, United States, 28054
        • Site Reference ID/Investigator# 92413
      • Winston-Salem, North Carolina, United States, 27103
        • Site Reference ID/Investigator# 87733
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Site Reference ID/Investigator# 83735
      • Columbus, Ohio, United States, 43210
        • Site Reference ID/Investigator# 91813
      • Toledo, Ohio, United States, 43606
        • Site Reference ID/Investigator# 83738
    • Oregon
      • Portland, Oregon, United States, 97225
        • Site Reference ID/Investigator# 91693
      • Springfield, Oregon, United States, 97447
        • Site Reference ID/Investigator# 89182
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Site Reference ID/Investigator# 83734
    • Tennessee
      • Knoxville, Tennessee, United States, 37923
        • Site Reference ID/Investigator# 83730
      • Memphis, Tennessee, United States, 38120
        • Site Reference ID/Investigator# 101876
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Site Reference ID/Investigator# 90614
      • Richmond, Virginia, United States, 23225
        • Site Reference ID/Investigator# 83725
    • Washington
      • Tacoma, Washington, United States, 98405
        • Site Reference ID/Investigator# 87714
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Site Reference ID/Investigator# 91814
      • Milwaukee, Wisconsin, United States, 53215
        • Site Reference ID/Investigator# 87739

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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.
Time Frame: Up through Day 7
Up through Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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
Time Frame: Up through Day 90
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)
Time Frame: Up through Day 60
Up through Day 60
Proportion of subjects developing AKI as defined by the Risk, Injury, Failure, Loss, or ESRD (RIFLE) model
Time Frame: Up through Day 7
Up through Day 7
Proportion of subjects developing AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) model
Time Frame: Up through Day 7
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
Time Frame: Up through Day 90
Up through Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M13-796
  • 2012-003942-33 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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