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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 Ris...

Update Il y a 4 ans
Reference: EUCTR2012-005710-19

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

Woman and Man

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Extract

- To determine the safety and pharmacokinetics of 800 mcg/kg intravenous (IV) infusions of ABT-719 in the first 6 subjects enrolled who are at risk of acute kidney injury (AKI) and undergoing high risk major surgery. -To compare the safety and efficacy of doses of 800 mcg/kg, 1600 mcg/kg and 2100 mcg/kg IV infusions of ABT-719 to placebo in subjects who are at risk of AKI and undergoing high risk major surgery.

Inclusion criteria

  • acute kidney injury

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