Clinical trial NCT01897519: 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
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cardiothoracic Surgery
Vascular Surgery
Keywords: High risk surgery
Acute Kidney Injury
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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.

Primary outcomes:
measure: Change in urine Neutrophil Gelatinase-Associated Lipocalin (NGAL)
timeFrame: Day 0 to Day 7
Secondary outcomes:
measure: Proportion of subjects that develop composite event at 90 days post surgery
timeFrame: 90 Day
measure: Proportion of subjects that develop a composite event at 60 days post surgery
timeFrame: 60 Days
measure: Proportion of subjects that develop the Acute Kidney Injury Network (AKIN) scoring criteria
timeFrame: Day 7
measure: Proportion of subjects that develop the Kidney Disease Improving Global Outcomes (KDIGO) scoring criteria
timeFrame: Day 7
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Site Reference ID/Investigator# 96295
state: Florida
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 96778
state: Florida
city: Tampa
country: United States
facility: Site Reference ID/Investigator# 96301
state: Florida
city: Fort Wayne
country: United States
facility: Site Reference ID/Investigator# 96302
state: Indiana
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 101961
state: Indiana
city: Boston
country: United States
facility: Site Reference ID/Investigator# 103356
state: Massachusetts
city: Boston
country: United States
facility: Site Reference ID/Investigator# 96303
state: Massachusetts
city: Grand Blanc
country: United States
facility: Site Reference ID/Investigator# 96997
state: Michigan
city: Petoskey
country: United States
facility: Site Reference ID/Investigator# 97878
state: Michigan
city: Royal Oak
country: United States
facility: Site Reference ID/Investigator# 99377
state: Michigan
city: West Orange
country: United States
facility: Site Reference ID/Investigator# 99317
state: New Jersey
city: New York
country: United States
facility: Site Reference ID/Investigator# 96996
state: New York
city: Durham
country: United States
facility: Site Reference ID/Investigator# 96296
state: North Carolina
city: Cleveland
country: United States
facility: Site Reference ID/Investigator# 102020
state: Ohio
city: Columbus
country: United States
facility: Site Reference ID/Investigator# 103355
state: Ohio
city: Pittsburgh
country: United States
facility: Site Reference ID/Investigator# 97556
state: Pennsylvania
city: Providence
country: United States
facility: Site Reference ID/Investigator# 103316
state: Rhode Island
city: Memphis
country: United States
facility: Site Reference ID/Investigator# 102019
state: Tennessee
city: Charlottesville
country: United States
facility: Site Reference ID/Investigator# 108255
state: Virginia
city: Milwaukee
country: United States
facility: Site Reference ID/Investigator# 96300
state: Wisconsin
city: Aarhus N
country: Denmark
facility: Site Reference ID/Investigator# 105755
city: Kolding
country: Denmark
facility: Site Reference ID/Investigator# 105757
city: Odense C
country: Denmark
facility: Site Reference ID/Investigator# 105756
Study officials:
affiliation: AbbVie
name: Ann Eldred, MD
role: STUDY_DIRECTOR
References: