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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

Primary Purpose

Cardiothoracic Surgery, Vascular Surgery

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Placebo

ABT-719

About this trial

This is an interventional prevention trial for Cardiothoracic Surgery focused on measuring High risk surgery, Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1 lower dose ABT-719

Arm 2 intermediate dose ABT-719

Arm 3 high dose ABT-719

Arm 4 Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Proportion of subjects that develop the Acute Kidney Injury Network (AKIN) scoring criteria

Proportion of subjects that develop the Kidney Disease Improving Global Outcomes (KDIGO) scoring criteria

Full Information

NCT ID

NCT01897519

First Posted

May 10, 2013

Last Updated

June 5, 2014

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT01897519

Brief Title

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

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Terminated

Why Stopped

Topline results from study M13-796 showed an overall lack of efficacy. There were no safety concerns.

Study Start Date

May 2013 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiothoracic Surgery, Vascular Surgery

Keywords

High risk surgery, Acute Kidney Injury

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1 lower dose ABT-719

Arm Type

Experimental

Arm Title

Arm 2 intermediate dose ABT-719

Arm Type

Experimental

Arm Title

Arm 3 high dose ABT-719

Arm Type

Experimental

Arm Title

Arm 4 Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo infusion

Intervention Type

Drug

Intervention Name(s)

ABT-719

Intervention Description

Arm 1 lower dose, arm 2 intermediate dose, arm 3 high dose

Primary Outcome Measure Information:

Title

Change in urine Neutrophil Gelatinase-Associated Lipocalin (NGAL)

Description

Comparison between each ABT-719 dose group versus placebo in the mean maximal change from baseline in urine NGAL from Day 0 - Day 7.

Time Frame

Day 0 to Day 7

Secondary Outcome Measure Information:

Title

Proportion of subjects that develop composite event at 90 days post surgery

Description

Time Frame

90 Day

Title

Proportion of subjects that develop a composite event at 60 days post surgery

Description

Time Frame

60 Days

Title

Proportion of subjects that develop the Acute Kidney Injury Network (AKIN) scoring criteria

Time Frame

Day 7

Title

Proportion of subjects that develop the Kidney Disease Improving Global Outcomes (KDIGO) scoring criteria

Time Frame

Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ann Eldred, MD

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator# 96295

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Site Reference ID/Investigator# 96778

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

Site Reference ID/Investigator# 96301

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Site Reference ID/Investigator# 96302

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46804

Country

United States

Facility Name

Site Reference ID/Investigator# 101961

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46237

Country

United States

Facility Name

Site Reference ID/Investigator# 103356

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Site Reference ID/Investigator# 96303

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02135

Country

United States

Facility Name

Site Reference ID/Investigator# 96997

City

Grand Blanc

State/Province

Michigan

ZIP/Postal Code

48439

Country

United States

Facility Name

Site Reference ID/Investigator# 97878

City

Petoskey

State/Province

Michigan

ZIP/Postal Code

49770

Country

United States

Facility Name

Site Reference ID/Investigator# 99377

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Facility Name

Site Reference ID/Investigator# 99317

City

West Orange

State/Province

New Jersey

ZIP/Postal Code

07052

Country

United States

Facility Name

Site Reference ID/Investigator# 96996

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Site Reference ID/Investigator# 96296

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Site Reference ID/Investigator# 102020

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Site Reference ID/Investigator# 103355

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Site Reference ID/Investigator# 97556

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

Site Reference ID/Investigator# 103316

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Site Reference ID/Investigator# 102019

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Facility Name

Site Reference ID/Investigator# 108255

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Site Reference ID/Investigator# 96300

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53215

Country

United States

Facility Name

Site Reference ID/Investigator# 105755

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Site Reference ID/Investigator# 105757

City

Kolding

ZIP/Postal Code

6000

Country

Denmark

Facility Name

Site Reference ID/Investigator# 105756

City

Odense C

ZIP/Postal Code

5000

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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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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

Cardiothoracic Surgery, Vascular Surgery

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial