A Randomized, Double-Blind, Placebo Controlled , Phase 2 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Acute Kidney Injury in Subjects at High Risk for AKI Following Cardiac Surgery

QRK209 [NCT02610283]

Description: This trial is designed to evaluate QPI-1002 versus placebo for the prevention of AKI in subjects who are at high risk for AKI following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.

Drug: QPI-1002; Drug: Placebo

Primary Investigator: Answini

Drug/Device Information
To evaluate the efficacy and safety of QPI-1002 for the prevention of acute kidney injury in subjects at high risk for AKI following cardiac surgery
QPI-1002 is a synthetic small interfering ribonucleic acid (siRNA)
The injection will be administered via IV bolus, at a dose of 10mg/kg, over a period of 1-2 minutes
QPI-1002 is to be administered 4 hours ± 30 minutes after discontinuation of cardiopulmonary bypass (CPB) and modified ultrafiltration
In case of non-CPB surgery, QPI-1002 will be administered at 4 hours ± 30 minutes after the last coronary bypass and completion of anastomosis
Randomized stratified by eGFR (≥ 60 ml/min/1.73m2 vs. < 60 ml/min/1.73 m2), use of coronary pulmonary bypass (yes/no) and circulatory arrest (yes/no) to a 10 mg/kg dose of QPI-1002 versus placebo
Quark Pharmaceuticals, Inc.
Major Inclusion and Exclusion
Age ≥ 45
Have stable renal function per Investigator assessment and no known increase in serum creatinine of ≥ 0.3
Scheduled to undergo non-emergent open chest cavity cardiovascular surgeries, including use of coronary pulmonary bypass (CPB) and no CPB
No eGFR ≤ 20
No emergent surgeries
No transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR) or single vessel, mid-CAB off-pump surgeries or left ventricular assist device (LVAD) implantation