CorMedix Inc. (“CorMedix”) (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, announced it successfully completed patient enrollment in its phase II Contrast-Induced Acute Kidney Injury (“CI-AKI”) study with its oral drug candidate CRMD001.
CI-AKI, also referred to as Contrast Induced Nephropathy (“CIN”), with its associated morbidity and mortality each year afflicts about one-third of the approximate 325,000 high risk patients with Chronic Kidney Disease (“CKD”) in the U.S. who undergo angiography for vascular imaging. If effective, CRMD001 treatment could significantly reduce the occurrence of CIN and its complications.
The double blind, placebo-controlled randomized phase II study evaluates the safety and efficacy of CRMD001 on biomarkers of acute kidney injury and kidney function. The study was conducted in high risk patients who have CKD and are undergoing a coronary angiography and receiving an iodinated radiocontrast agent. CorMedix expects to report final results before year-end.
Commenting on the study, CorMedix President and CEO, John C. Houghton, stated, “We are very pleased to have successfully completed patient enrollment in our Phase II study, for an indication which has no approved therapeutic treatment. We are eagerly awaiting the results.”
Currently, the standard of care to prevent CI-AKI in high risk patients with CKD is hydration and avoidance of nephrotoxic drugs. There is no single therapeutic intervention that has conclusively and consistently proven to be effective in the prevention of CI-AKI, and there are no FDA-approved preventative treatments.
About Contrast Induced Acute Kidney Injury (CI-AKI)
CI-AKI is a potentially serious complication arising from the use of iodinated contrast media used in X-ray procedures to visualize and assess the status of blood vessels in different parts of the body. CI-AKI is most commonly defined as a new onset or exacerbation of renal dysfunction after contrast administration without other identifiable causes. It is the third most common cause of hospital-acquired renal insufficiency (11% of cases) after low blood pressure and major surgery, and is associated with increased mortality, cardiovascular complications (myocardial infarction, stroke, heart failure, etc.), the need for dialysis, permanent kidney damage and delayed discharge/re-hospitalization. In addition, CI-AKI, or the risk of developing CI-AKI, disrupts the workflow of the catheterization laboratory. The most important risk factor for a patient developing CI-AKI is the presence of chronic kidney disease.