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

Phase 2TerminatedNCT01897519

AbbVie56 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Cardiothoracic Surgery Vascular Surgery

Interventions

PlaceboDRUG

Placebo infusion

ABT-719DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (23)

Site Reference ID/Investigator# 96295

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 0 to Day 7

Secondary Outcomes

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.

Time frame: 90 Day

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.

Time frame: 60 Days

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

Time frame: Day 7

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

Time frame: Day 7

Data from ClinicalTrials.gov

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