A Phase 2b, Randomized, Double-Blind,Placebo-Controlled, Safety and Efficacy Trial ofMultiple Dosing Regimens of ABT-719 for thePrevention of Acute Kidney Injury in SubjectsUndergoing High Risk Major Surgery

• Conditions: Acute Kidney Injury; MedDRA version: 16.1Level: LLTClassification code 10069339Term: Acute kidney injurySystem Organ Class: 100000004857; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2012-005710-19-DK
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-28
• Last Update Posted: 28 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Subject must be male or female, age >= 18 years old
2. Subject undergoing open aortic surgery or open surgery of the renal artery
or
Subject undergoing surgery (vascular surgery, endovascular surgery, non-CPB cardiac surgery or transcatheter aortic valve replacement (TAVR)) of anticipated duration of > =2 hours with a least one of the follwing:
a. eGFR > 15 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 as determined by CKD EPI formula at Screening, OR
b. Subject is Type 1 or 2 diabetic requiring anti-diabetic medication (oral or insulin), OR
c. Subject has documented history of proteinuria > 0.3 g/day (spot urine protein/creatinine ratio [UPCR] >= 0.3 g/g or urine dip stick 2+ or more evaluated at screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 340

Exclusion Criteria

1. Active peptic ulcer disease with history of upper GI bleed.
2. Has ongoing sepsis or history of sepsis within the last 2 weeks or
untreated diagnosed infection prior to Screening visit
3. Has known/documented history of RIFLE or AKIN within the previous 4 weeks
4. Subject with cancer and on active nephrotoxic chemotherapy (treatment), or have received (nephrotoxic chemotherapy in the previous 10 weeks), or are expecting to receive nephrotoxic chemotherapy in the next 3 months and/or life expectancy of 1 year or less

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified