With its new Special Protocol Assessment with the U.S. Food and Drug Administration, CorMedix will be conducting Phase III research for Deferiprone as an indication for Contrast-Induced Acute Kidney Injury. Often times, the importance or value of an SPA is overlooked, but it the case of CorMedix, it certainly warrants a closer look.
A portion of the article:
CorMedix, Inc. (AMEX: CRMD; StockTwits: $CRMD) recently was the recipient of a SPA agreement with the U.S. FDA for their drug, Deferiprone, as an indication for Contrast-Induced Acute Kidney Injury. The SPA takes into consideration a modification to the dosing regimen contained in the previously submitted protocol. Scheduled to be conducted in over 80 centers worldwide an encompassing more than 800 patients, the study will assess the efficacy and safety of Deferiprone (CRMD001) in the reduction of morbidity and mortality in patients with Chronic Kidney Disease (CKD) undergoing diagnostic or interventional cardiac procedures and receiving an iodinated radiocontrast agent.
According to research by Somjot S. Brar et al. published in the Clinical Journal of the American Society of Nephrology,
“Contrast-induced acute kidney injury (CI-AKI) is probably the most common iatrogenic cause of acute kidney injury and a common complication of iodinated contrast medium exposure, with a published incidence ranging from 2 to 50%. It results in increased morbidity, prolonged hospital stay, and increased healthcare expenditure and is associated with a higher mortality.”
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