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 has been terminated.
(Topline results from study M13-796 showed an overall lack of efficacy. There were no safety concerns.)
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01897519
First received: May 10, 2013
Last updated: June 5, 2014
Last verified: June 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
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 ]

Enrollment: 56
Study Start Date: May 2013
Study Completion Date: May 2014
Primary Completion Date: May 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, 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

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01897519

  Hide Study Locations
Locations
United States, Florida
Site Reference ID/Investigator# 96295
Gainesville, Florida, United States, 32610
Site Reference ID/Investigator# 96778
Jacksonville, Florida, United States, 32207
Site Reference ID/Investigator# 96301
Tampa, Florida, United States, 33613
United States, Indiana
Site Reference ID/Investigator# 96302
Fort Wayne, Indiana, United States, 46804
Site Reference ID/Investigator# 101961
Indianapolis, Indiana, United States, 46237
United States, Massachusetts
Site Reference ID/Investigator# 96303
Boston, Massachusetts, United States, 02135
Site Reference ID/Investigator# 103356
Boston, Massachusetts, United States, 02115
United States, Michigan
Site Reference ID/Investigator# 96997
Grand Blanc, Michigan, United States, 48439
Site Reference ID/Investigator# 97878
Petoskey, Michigan, United States, 49770
Site Reference ID/Investigator# 99377
Royal Oak, Michigan, United States, 48073
United States, New Jersey
Site Reference ID/Investigator# 99317
West Orange, New Jersey, United States, 07052
United States, New York
Site Reference ID/Investigator# 96996
New York, New York, United States, 10032
United States, North Carolina
Site Reference ID/Investigator# 96296
Durham, North Carolina, United States, 27710
United States, Ohio
Site Reference ID/Investigator# 102020
Cleveland, Ohio, United States, 44195
Site Reference ID/Investigator# 103355
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Site Reference ID/Investigator# 97556
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Site Reference ID/Investigator# 103316
Providence, Rhode Island, United States, 02903
United States, Tennessee
Site Reference ID/Investigator# 102019
Memphis, Tennessee, United States, 38120
United States, Virginia
Site Reference ID/Investigator# 108255
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Site Reference ID/Investigator# 96300
Milwaukee, Wisconsin, United States, 53215
Denmark
Site Reference ID/Investigator# 105755
Aarhus N, Denmark, 8200
Site Reference ID/Investigator# 105757
Kolding, Denmark, 6000
Site Reference ID/Investigator# 105756
Odense C, Denmark, 5000
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: June 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 July 31, 2014