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

  Show 41 Study Locations
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 23, 2014