First patient treated in PLC Systems' RenalGuard U.S. trial
PLC Systems, focused on innovative medical device technologies, has successfully enrolled the first patient in the CIN-RG trial, its pivotal trial to study the efficacy of its RenalGuard therapy and RenalGuard system in the prevention of Contrast-Induced Nephropathy (CIN).
"RenalGuard offers us the potential for a method to reduce the incidence of CIN while allowing me as an interventional cardiologist to focus on the catheterization without having to worry that the contrast may be damaging the patient's kidney," said Dr. Michael Kim, director of the Coronary Care Unit at Mount Sinai Hospital, who enrolled the first patient.
The study is designed as an adaptive, randomized, controlled trial at up to 30 sites in the U.S. Enrollment will include at least 326 patients and potentially up to 652 patients, depending upon the outcome of a sample size re-estimation after 163 patients. The re-estimation enables investigators to ensure the trial is sufficiently powered so the final results are statistically meaningful.
"Using lessons learned from the clinical trials of RenalGuard in Europe, as well as other clinical developments since 2008, we made slight modifications to our original trial protocol that we believe will make it more robust,” said Mark R. Tauscher, president and CEO of PLC.
PLC's U.S. study builds upon two clinical trials by independent clinical investigators in Europe, both of which showed significant reductions in incident rates of CIN in at-risk patients through the use of RenalGuard compared to the current standard of care.