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

AbbVie

Status and phase: Terminated; Phase 2

Conditions: Vascular Surgery; Cardiothoracic Surgery

Treatments: Drug: Placebo; Drug: ABT-719

Study type: Interventional

Funder types: Industry

Identifiers

NCT01897519

M13-958

2012-005710-19 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 4 patient groups, including a placebo group

Arm 1 lower dose ABT-719

Experimental group

Treatment:

Drug: ABT-719

Arm 2 intermediate dose ABT-719

Experimental group

Treatment:

Drug: ABT-719

Arm 3 high dose ABT-719

Experimental group

Treatment:

Drug: ABT-719

Arm 4 Placebo

Placebo Comparator group

Treatment:

Drug: Placebo