Trial record 1 of 1 for:    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
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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 Surgery

This study is currently recruiting participants.
Verified January 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01897519
First received: May 10, 2013
Last updated: January 5, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Cardiothoracic Surgery
Vascular Surgery
Abdominal Surgery
Drug: Placebo
Drug: ABT-719
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Major Surgery

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change in urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) [ Time Frame: Day 0 to Day 7 ] [ Designated as safety issue: Yes ]
    Comparison between each ABT-719 dose group versus placebo in the mean maximal change from baseline in urine NGAL from Day 0 - Day 7.


Secondary Outcome Measures:
  • Proportion of subjects that develop composite event at 90 days post surgery [ Time Frame: 90 Day ] [ Designated as safety issue: Yes ]
    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.

  • Proportion of subjects that develop a composite event at 60 days post surgery [ Time Frame: 60 Days ] [ Designated as safety issue: Yes ]
    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.

  • Proportion of subjects that develop the Acute Kidney Injury Network (AKIN) scoring criteria [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects that develop the Kidney Disease Improving Global Outcomes (KDIGO) scoring criteria [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: May 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 lower dose ABT-719 Drug: ABT-719
Arm 1 lower dose, arm 2 intermediate dose, arrm 3 high dose
Experimental: Arm 2 intermediate dose ABT-719 Drug: ABT-719
Arm 1 lower dose, arm 2 intermediate dose, arrm 3 high dose
Experimental: Arm 3 high dose ABT-719 Drug: ABT-719
Arm 1 lower dose, arm 2 intermediate dose, arrm 3 high dose
Placebo Comparator: Arm 4 Placebo Drug: Placebo
Placebo infusion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Patients undergoing high risk major surgery (i.e., abdominal surgery, vascular surgery, cardiothoracic surgery) with baseline chronic kidney disease (stage 3 and 4) and having diabetes or proteinuria or history of cardiovascular disease

Exclusion Criteria:

  • Ongoing or recent history of sepsis
  • Has recent documented acute kidney injury.
  • Recent history of congestive heart failure
  • Subject is scheduled to have a total or partial nephrectomy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01897519

Contacts
Contact: Donna Radjenovich, MS 847-938-7909 donna.radjenovich@abbvie.com
Contact: Bonny Tzortzis, MS 847-935-9494 bonny.tzortzis@abbvie.com

  Hide Study Locations
Locations
United States, Alabama
Site Reference ID/Investigator# 106879 Recruiting
Birmingham, Alabama, United States, 35294
Principal Investigator: Site Reference ID/Investigator# 106879         
United States, Arizona
Site Reference ID/Investigator# 97555 Not yet recruiting
Phoenix, Arizona, United States, 85006
Principal Investigator: Site Reference ID/Investigator# 97555         
United States, California
Site Reference ID/Investigator# 106876 Not yet recruiting
Laguna Hills, California, United States, 92653
Principal Investigator: Site Reference ID/Investigator# 106876         
Site Reference ID/Investigator# 106877 Not yet recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Site Reference ID/Investigator# 106877         
Site Reference ID/Investigator# 101969 Recruiting
Palo Alto, California, United States, 94305-5640
Principal Investigator: Site Reference ID/Investigator# 101969         
United States, District of Columbia
Site Reference ID/Investigator# 101295 Recruiting
Washington, District of Columbia, United States, 20037
Principal Investigator: Site Reference ID/Investigator# 101295         
United States, Florida
Site Reference ID/Investigator# 96295 Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Site Reference ID/Investigator# 96295         
Site Reference ID/Investigator# 96778 Recruiting
Jacksonville, Florida, United States, 32207
Principal Investigator: Site Reference ID/Investigator# 96778         
Site Reference ID/Investigator# 96299 Recruiting
Jacksonville, Florida, United States, 32216
Principal Investigator: Site Reference ID/Investigator# 96299         
Site Reference ID/Investigator# 97875 Not yet recruiting
Miami, Florida, United States, 33136
Principal Investigator: Site Reference ID/Investigator# 97875         
Site Reference ID/Investigator# 96301 Recruiting
Tampa, Florida, United States, 33613
Principal Investigator: Site Reference ID/Investigator# 96301         
Site Reference ID/Investigator# 106897 Not yet recruiting
Weston, Florida, United States, 33331
Principal Investigator: Site Reference ID/Investigator# 106897         
United States, Georgia
Site Reference ID/Investigator# 97557 Not yet recruiting
Augusta, Georgia, United States, 30912
Principal Investigator: Site Reference ID/Investigator# 97557         
United States, Illinois
Site Reference ID/Investigator# 96298 Recruiting
Springfield, Illinois, United States, 62794
Principal Investigator: Site Reference ID/Investigator# 96298         
United States, Indiana
Site Reference ID/Investigator# 96302 Recruiting
Fort Wayne, Indiana, United States, 46804
Principal Investigator: Site Reference ID/Investigator# 96302         
Site Reference ID/Investigator# 101961 Recruiting
Indianapolis, Indiana, United States, 46237
Principal Investigator: Site Reference ID/Investigator# 101961         
United States, Kentucky
Site Reference ID/Investigator# 97516 Recruiting
Lexington, Kentucky, United States, 40536
Principal Investigator: Site Reference ID/Investigator# 97516         
United States, Maryland
Site Reference ID/Investigator# 100295 Recruiting
Bethesda, Maryland, United States, 20814
Principal Investigator: Site Reference ID/Investigator# 100295         
United States, Massachusetts
Site Reference ID/Investigator# 96303 Recruiting
Boston, Massachusetts, United States, 02135
Principal Investigator: Site Reference ID/Investigator# 96303         
Site Reference ID/Investigator# 103356 Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Site Reference ID/Investigator# 103356         
United States, Michigan
Site Reference ID/Investigator# 96997 Recruiting
Grand Blanc, Michigan, United States, 48439
Principal Investigator: Site Reference ID/Investigator# 96997         
Site Reference ID/Investigator# 97878 Recruiting
Petoskey, Michigan, United States, 49770
Principal Investigator: Site Reference ID/Investigator# 97878         
Site Reference ID/Investigator# 99377 Recruiting
Royal Oak, Michigan, United States, 48073
Principal Investigator: Site Reference ID/Investigator# 99377         
United States, Missouri
Site Reference ID/Investigator# 96995 Recruiting
St. Louis, Missouri, United States, 63131
Principal Investigator: Site Reference ID/Investigator# 96995         
United States, New Jersey
Site Reference ID/Investigator# 99317 Recruiting
West Orange, New Jersey, United States, 07052
Principal Investigator: Site Reference ID/Investigator# 99317         
United States, New York
Site Reference ID/Investigator# 105415 Recruiting
Albany, New York, United States, 12208
Principal Investigator: Site Reference ID/Investigator# 105415         
Site Reference ID/Investigator# 96996 Recruiting
New York, New York, United States, 10032
Principal Investigator: Site Reference ID/Investigator# 96996         
United States, North Carolina
Site Reference ID/Investigator# 96296 Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Site Reference ID/Investigator# 96296         
United States, Ohio
Site Reference ID/Investigator# 102020 Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Site Reference ID/Investigator# 102020         
Site Reference ID/Investigator# 103355 Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Site Reference ID/Investigator# 103355         
United States, Pennsylvania
Site Reference ID/Investigator# 97556 Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Principal Investigator: Site Reference ID/Investigator# 97556         
United States, Rhode Island
Site Reference ID/Investigator# 103316 Recruiting
Providence, Rhode Island, United States, 02903
Principal Investigator: Site Reference ID/Investigator# 103316         
United States, Tennessee
Site Reference ID/Investigator# 102019 Recruiting
Memphis, Tennessee, United States, 38120
Principal Investigator: Site Reference ID/Investigator# 102019         
United States, Utah
Site Reference ID/Investigator# 97862 Recruiting
Salt Lake City, Utah, United States, 84124
Principal Investigator: Site Reference ID/Investigator# 97862         
United States, Virginia
Site Reference ID/Investigator# 108255 Not yet recruiting
Charlottesville, Virginia, United States, 22908
Principal Investigator: Site Reference ID/Investigator# 108255         
Site Reference ID/Investigator# 97835 Recruiting
Richmond, Virginia, United States, 23225
Principal Investigator: Site Reference ID/Investigator# 97835         
United States, Washington
Site Reference ID/Investigator# 97558 Recruiting
Tacoma, Washington, United States, 98405
Principal Investigator: Site Reference ID/Investigator# 97558         
United States, Wisconsin
Site Reference ID/Investigator# 96300 Recruiting
Milwaukee, Wisconsin, United States, 53215
Principal Investigator: Site Reference ID/Investigator# 96300         
Denmark
Site Reference ID/Investigator# 105755 Not yet recruiting
Aarhus N, Denmark, 8200
Principal Investigator: Site Reference ID/Investigator# 105755         
Site Reference ID/Investigator# 105757 Not yet recruiting
Kolding, Denmark, 6000
Principal Investigator: Site Reference ID/Investigator# 105757         
Site Reference ID/Investigator# 105756 Not yet recruiting
Odense C, Denmark, 5000
Principal Investigator: Site Reference ID/Investigator# 105756         
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Ann Eldred, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01897519     History of Changes
Other Study ID Numbers: M13-958, 2012-005710-19
Study First Received: May 10, 2013
Last Updated: January 5, 2014
Health Authority: Denmark: Ethics Committee
United States: Institutional Review Board
United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by AbbVie:
High risk surgery
Acute Kidney Injury

Additional relevant MeSH terms:
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014