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

Vascular Surgery Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01897519
• Other study ID #: M13-958
• Secondary ID: 2012-005710-19
• Status: Terminated
• Phase: Phase 2
• First received: May 10, 2013
• Last updated: June 5, 2014
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeUnited States: Institutional Review BoardUnited States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiothoracic Surgery
• Vascular Surgery

Intervention

Drug:
• Placebo
Placebo infusion
• ABT-719
Arm 1 lower dose, arm 2 intermediate dose, arm 3 high dose

Locations

Country	Name	City	State
Denmark	Site Reference ID/Investigator# 105755	Aarhus N
Denmark	Site Reference ID/Investigator# 105757	Kolding
Denmark	Site Reference ID/Investigator# 105756	Odense C
United States	Site Reference ID/Investigator# 103356	Boston	Massachusetts
United States	Site Reference ID/Investigator# 96303	Boston	Massachusetts
United States	Site Reference ID/Investigator# 108255	Charlottesville	Virginia
United States	Site Reference ID/Investigator# 102020	Cleveland	Ohio
United States	Site Reference ID/Investigator# 103355	Columbus	Ohio
United States	Site Reference ID/Investigator# 96296	Durham	North Carolina
United States	Site Reference ID/Investigator# 96302	Fort Wayne	Indiana
United States	Site Reference ID/Investigator# 96295	Gainesville	Florida
United States	Site Reference ID/Investigator# 96997	Grand Blanc	Michigan
United States	Site Reference ID/Investigator# 101961	Indianapolis	Indiana
United States	Site Reference ID/Investigator# 96778	Jacksonville	Florida
United States	Site Reference ID/Investigator# 102019	Memphis	Tennessee
United States	Site Reference ID/Investigator# 96300	Milwaukee	Wisconsin
United States	Site Reference ID/Investigator# 96996	New York	New York
United States	Site Reference ID/Investigator# 97878	Petoskey	Michigan
United States	Site Reference ID/Investigator# 97556	Pittsburgh	Pennsylvania
United States	Site Reference ID/Investigator# 103316	Providence	Rhode Island
United States	Site Reference ID/Investigator# 99377	Royal Oak	Michigan
United States	Site Reference ID/Investigator# 96301	Tampa	Florida
United States	Site Reference ID/Investigator# 99317	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in urine Neutrophil Gelatinase-Associated Lipocalin (NGAL)	Comparison between each ABT-719 dose group versus placebo in the mean maximal change from baseline in urine NGAL from Day 0 - Day 7.	Day 0 to Day 7	Yes
Secondary	Proportion of subjects that develop composite event at 90 days post surgery	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.	90 Day	Yes
Secondary	Proportion of subjects that develop a composite event at 60 days post surgery	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.	60 Days	Yes
Secondary	Proportion of subjects that develop the Acute Kidney Injury Network (AKIN) scoring criteria		Day 7	Yes
Secondary	Proportion of subjects that develop the Kidney Disease Improving Global Outcomes (KDIGO) scoring criteria		Day 7	Yes