The REMEDIAL II trial is a randomized, open-label controlled clinical trial at the Clinica Mediterranea in Naples, Italy under the leadership of Dr. Carlo Briguori, a world-renowned CIN prevention specialist. Final results were presented as a Late Breaking Clinical Trial at the American College of Cardiology (ACC) annual conference in March 2011, and published in Circulation in August 2011.
Dr. Briguori reported on data from 294 patients with chronic kidney disease (CKD) who underwent elective catheterization procedures. The primary end point for the study used a definition of CIN as a rise in serum creatinine (SCr) of 0.3mg/dl over the patient’s baseline reading. The results – the RenalGuard group had a CIN incidence rate of 46% lower than the control group using this definition of CIN. As secondary endpoints, he also reported a 60% reduction in CIN when defining CIN as a 0.5mg/dl absolute rise in SCr and an 80% reduction of CIN when defining CIN as a 25% rise over baseline SCr. In addition, the data showed that RenalGuard reduced the need for dialysis from 4% to 0.7%, an 85% reduction.