Sweden-based NeuroVive Pharmaceutical has enrolled first patient in its Phase II trial (CiPRICS) of its product, CicloMulsion, for the treatment of acute kidney injury.
Around 150 patients will be enrolled in the double-blind, randomised and placebo-controlled clinical Phase II trial at the department of Cardiothoracic Surgery at Skåne University Hospital in Lund.
The trial is designed to evaluate CicloMulsion's ability to prevent acute kidney injury during heart surgery. During the trial, patients will be treated with CicloMulsion or placebo prior to coronary bypass surgery.
The trial is aimed to evaluate whether pre-treatment with a mitochondria-protecting drug protects the kidneys against injury and prevents the compromised renal function that can result from altered blood supply during cardiac surgery.
NeuroVive senior scientist Magnus Hansson said: "There is a clear link between acute kidney injury during cardiac surgery and later medical conditions and death.
"This means that there's an urgent need to try to prevent this kind of injury. In pre-clinical trials, the stabilizing effect of cyclophilin inhibitors on mitochondria has been shown to protect a number of different organs against injury resulting from insufficient blood flow.
"The problem often relates to the timely administration of the drug. In this respect, acute kidney injury during cardiac surgery presents a relatively unique scenario, as the procedure makes it possible to protect the kidneys and other organs before the altered blood flow occurs.
"This means that we have the ability to potentially protect organs also against the initial injury, not only against reperfusion injury."
The company said that in addition to the patients' renal function, which will be closely monitored, other markers, such as markers for cardiac injury, will also be analysed in the trial.