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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01897519

Enrollment

Registered

2013-07-12

Start date

2013-05-31

Completion date

2014-05-31

Last updated

2014-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiothoracic Surgery, Vascular Surgery

Keywords

High risk surgery, Acute Kidney Injury

Brief summary

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

Interventions

DRUGPlacebo

Placebo infusion

DRUGABT-719

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in urine Neutrophil Gelatinase-Associated Lipocalin (NGAL)	Day 0 to Day 7	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

Measure	Time frame	Description
Proportion of subjects that develop composite event at 90 days post surgery	90 Day	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	60 Days	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	Day 7	—
Proportion of subjects that develop the Kidney Disease Improving Global Outcomes (KDIGO) scoring criteria	Day 7	—

Countries

Denmark, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026