A study to evaluate the efficacy and safety of QPI-1002.
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of QPI-1002 For the Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery
IRAS ID
253302
Contact name
John Prowle
Contact email
Sponsor organisation
Quark Pharmaceuticals, Inc.
Eudract number
2018-000757-49
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
This study is being done to find out how safe and effective the study drug QPI-1002 is at preventing Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury (AKI) following heart (cardiac) surgery.
During heart surgery, there are times when the supply of oxygen-rich blood to the kidney is lower. This lack of oxygen can cause injury or damage to kidney cells and switches on a protein called “p53”. p53 then causes damaged kidney cells to die. If too many kidney cells die, this can lead to AKI and MAKE.
QPI-1002 is designed to temporarily stop the body from making p53 protein. This may give the body time to repair and heal damaged kidney cells. QPI-1002 may prevent injury and progression of injury in the kidney that can lead to AKI and MAKE.
Subjects who qualify will be randomly assigned by chance (like the flip of a coin) to receive a single dose of either QPI-1002 or a placebo (a salt solution with no study drug) approximately 4 hours after heart surgery by infusion (a slow injection by means of a tube into a vein).
Approximately 1088 subjects from UK, Europe, Australia, New Zealand, Canada and the United States will be enrolled.
The study duration is 90 days.
There will be a screening visit within 28 days before planned heart surgery. After surgery, study visits will occur at 1, 2, 3, 4, 5, 7, 30, 60 and 90 days. Approximately, one year after the surgery subjects will return to the hospital for a Post-study visit.REC name
London - Brent Research Ethics Committee
REC reference
19/LO/0576
Date of REC Opinion
11 Jul 2019
REC opinion
Further Information Favourable Opinion