A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Surgery

June 5, 2014 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 Major Surgery

This study will evaluate the safety and efficacy of ABT-719 in patients undergoing high risk major surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • 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, 8200
        • Site Reference ID/Investigator# 105755
      • Kolding, Denmark, 6000
        • Site Reference ID/Investigator# 105757
      • Odense C, Denmark, 5000
        • Site Reference ID/Investigator# 105756
  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Site Reference ID/Investigator# 96295
      • Jacksonville, Florida, United States, 32207
        • Site Reference ID/Investigator# 96778
      • Tampa, Florida, United States, 33613
        • Site Reference ID/Investigator# 96301
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Site Reference ID/Investigator# 96302
      • Indianapolis, Indiana, United States, 46237
        • Site Reference ID/Investigator# 101961
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Site Reference ID/Investigator# 103356
      • Boston, Massachusetts, United States, 02135
        • Site Reference ID/Investigator# 96303
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Site Reference ID/Investigator# 96997
      • Petoskey, Michigan, United States, 49770
        • Site Reference ID/Investigator# 97878
      • Royal Oak, Michigan, United States, 48073
        • Site Reference ID/Investigator# 99377
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Site Reference ID/Investigator# 99317
    • New York
      • New York, New York, United States, 10032
        • Site Reference ID/Investigator# 96996
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Site Reference ID/Investigator# 96296
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Site Reference ID/Investigator# 102020
      • Columbus, Ohio, United States, 43210
        • Site Reference ID/Investigator# 103355
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Site Reference ID/Investigator# 97556
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Site Reference ID/Investigator# 103316
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Site Reference ID/Investigator# 102019
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Site Reference ID/Investigator# 108255
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Site Reference ID/Investigator# 96300

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Patients undergoing high risk major surgery in subjects with cardiovascular disease who are at risk of AKI.

Exclusion Criteria:

  • Ongoing or recent history of sepsis
  • Has recent documented acute kidney injury.
  • Subject is scheduled to have a total or partial nephrectomy.

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
Intervention / Treatment
EXPERIMENTAL: Arm 1 lower dose ABT-719
Drug: ABT-719
Arm 1 lower dose, arm 2 intermediate dose, arm 3 high dose
EXPERIMENTAL: Arm 2 intermediate dose ABT-719
Drug: ABT-719
Arm 1 lower dose, arm 2 intermediate dose, arm 3 high dose
EXPERIMENTAL: Arm 3 high dose ABT-719
Drug: ABT-719
Arm 1 lower dose, arm 2 intermediate dose, arm 3 high dose
PLACEBO_COMPARATOR: Arm 4 Placebo
Drug: Placebo
Placebo infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in urine Neutrophil Gelatinase-Associated Lipocalin (NGAL)
Time Frame: Day 0 to Day 7
Comparison between each ABT-719 dose group versus placebo in the mean maximal change from baseline in urine NGAL from Day 0 - Day 7.
Day 0 to Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects that develop composite event at 90 days post surgery
Time Frame: 90 Day
Develop at least one of the composite events: death, needing renal replacement therapy during the 90-day post operative period, or having a greater than 25% reduction in estimated or measured glomerular filtration rate.
90 Day
Proportion of subjects that develop a composite event at 60 days post surgery
Time Frame: 60 Days
Develop at least one of the composite events: death, needing renal replacement therapy during the 60-day post operative period, or having a greater than 25% reduction in estimated or measured glomerular filtration rate.
60 Days
Proportion of subjects that develop the Acute Kidney Injury Network (AKIN) scoring criteria
Time Frame: Day 7
Day 7
Proportion of subjects that develop the Kidney Disease Improving Global Outcomes (KDIGO) scoring criteria
Time Frame: Day 7
Day 7

Collaborators and Investigators

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

Sponsor

AbbVie

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

May 1, 2013

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

May 10, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (ESTIMATE)

July 12, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 6, 2014

Last Update Submitted That Met QC Criteria

June 5, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M13-958
  • 2012-005710-19 (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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