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

May 10, 2013
June 5, 2014
May 2013
May 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01897519 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Cardiothoracic Surgery
  • Vascular Surgery
  • Drug: Placebo
    Placebo infusion
  • Drug: ABT-719
    Arm 1 lower dose, arm 2 intermediate dose, arm 3 high dose
  • Experimental: Arm 1 lower dose ABT-719
    Intervention: Drug: ABT-719
  • Experimental: Arm 2 intermediate dose ABT-719
    Intervention: Drug: ABT-719
  • Experimental: Arm 3 high dose ABT-719
    Intervention: Drug: ABT-719
  • Placebo Comparator: Arm 4 Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
56
May 2014
May 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Denmark
 
NCT01897519
M13-958, 2012-005710-19
Yes
AbbVie
AbbVie
Not Provided
Study Director: Ann Eldred, MD AbbVie
AbbVie
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP