A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery

Summary

This study will evaluate the safety and efficacy of ABT-719 in preventing acute kidney injury in patients undergoing high risk cardiac surgery.

Timeline

Start

2013-02

Primary completion

2014-03

Completion

2014-03

Outcome

Missed primary endpoint

paper ABT-719 treatment did not lower AKI incidence using AKIN criteria PMID 27543797 ↗

paper P=0.966, 0.815, and 0.605, respectively PMID 27543797 ↗

Publications

• Results McCullough PA, Bennett-Guerrero E, Chawla LS, Beaver T, Mehta RL, Molitoris BA, Eldred A, Ball G, Lee HJ, Houser MT, Khan S. ABT-719 for the Prevention of Acute Kidney Injury in Patients Undergoing High-Risk Cardiac Surgery: A Randomized Phase 2b Clinical Trial. J Am Heart Assoc. 2016 Aug 20;5(8):e003549. doi: 10.1161/JAHA.116.003549.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MODIMELANOTIDE	Protein / enzyme biologic	800 ug/kg	—
Subject	MODIMELANOTIDE	Protein / enzyme biologic	1600 ug/kg	—
Subject	MODIMELANOTIDE	Protein / enzyme biologic	2100 ug/kg	—

Indications