Date: 2014-12-02
Type of information: Clinical research agreement
Compound: CicloMulsion®
Company: NeuroVive Pharmaceutical (Sweden) Skåne University Hospital (Sweden)
Therapeutic area: Cardiovascular diseases - Kidney diseases - Renal diseases
Type agreement: clinical researcb
Action mechanism:
Disease: prevention of acute kidney injury in patients undergoing heart surgery
Details: * On December 2, 2014, NeuroVive, the mitochondrial medicine company, has initiated a collaboration with Skåne University Hospital to complete a clinical phase II study on the evaluation of the company’s product CicloMulsion® regarding its ability to prevent acute kidney injury in 150 patients undergoing heart surgery. Enrolment to the study will begin in the first half of 2015 and is expected to continue until the end of 2016. NeuroVive’s product CicloMulsion® is already being evaluated in clinical studies focusing on protecting the heart and brain in connection with acute injury (known as NeuroSTAT® for brain protection). Drugs that protect the mitochondria also have significant potential to protect high-energy organs like the kidneys during surgery. Two clinical studies have shown that the active substance is safe for heart surgery and provides protection against diffuse injury*. This has led Skåne University Hospital to initiate a clinical study to evaluate the potential for protecting the kidneys using CicloMulsion® in cardiac surgery. The study is known as CiPRICS (Ciclosporin to Protect Renal function In Cardiac Surgery) and is a double-blind, randomized and placebo-controlled clinical phase II study to include a total of 150 patients. The patients will be treated with CicloMulsion® in connection with coronary artery bypass surgery at the Clinic for Cardiothoracic Surgery at Skåne University Hospital in Lund, Sweden. The study is investigator-initiated and is conducted with support from NeuroVive.
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