The US Food and Drug Administration (FDA) has granted approval for PLC Systems to initiate its US pivotal trial to study the efficacy of the company's RenalGuard Therapy and RenalGuard System in the prevention of contrast-induced nephropathy (CIN).
RenalGuard is a fully-automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media.
The study is an adaptive randomised controlled trial and 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 sample size re-estimation enables investigators to ensure the trial is sufficiently powered so the final results are statistically meaningful.
PLC's US study is based on two clinical trials which showed reductions in incident rates of CIN in at-risk patients through the use of RenalGuard compared to the current standard of care.