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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

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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

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

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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