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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

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ClinicalTrials.gov Identifier: NCT01897519
Recruitment Status : Terminated (Topline results from study M13-796 showed an overall lack of efficacy. There were no safety concerns.)
First Posted : July 12, 2013
Last Update Posted : June 6, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie

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

Condition or disease Intervention/treatment Phase
Cardiothoracic Surgery Vascular Surgery Drug: Placebo Drug: ABT-719 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Proportion of subjects that develop the Acute Kidney Injury Network (AKIN) scoring criteria [ Time Frame: Day 7 ]
  4. Proportion of subjects that develop the Kidney Disease Improving Global Outcomes (KDIGO) scoring criteria [ Time Frame: Day 7 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897519


  Show 23 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Ann Eldred, MD AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01897519     History of Changes
Other Study ID Numbers: M13-958
2012-005710-19 ( EudraCT Number )
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: June 6, 2014
Last Verified: June 2014

Keywords provided by AbbVie:
High risk surgery
Acute Kidney Injury

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