We are delighted to inform you that CVBF will provide its support in the RACERS study, a new clinical trial approved by AIFA (Agenzia Italiana del Farmaco) and coordinated by the University Hospital Polyclinic of Bari.
Acute Kidney Injury (AKI) is a common occurrence in patients hospitalized in the Intensive Care Units, with an estimated incidence of more than 50%. Sepsis is the major cause of AKI and increasing AKI severity is associated with increased mortality. Currently, treatment options for sepsis-induced AKI are limited to supportive care. The profound inflammatory response that takes place in this condition is the major cause of hemodynamic destabilization and progression to renal failure in septic patients. The main objective of the RACERS study, that will last two years, is to investigate whether the use of a novel drug (CER-001, a bioengineered HDL from Abionyx Pharma), in combination with standard of care treatment, is safe and effective, providing new potential strategies to treat septic patients, reducing the inflammatory response and preventing the progression to renal injury. Due to the mechanism of inflammatory response reduction, CER-001 can be considered a pleiotropic drug that will be tested in a wide range of medical conditions in which the inflammatory cascade becomes detrimental.
CVBF will be involved in the study as a CRO and will provide its support in the regulatory and monitoring activities.