RenalGuard Solutions has announced the STRENGTH trial, designed to evaluate the long-term clinical and economic impact of RenalGuard therapy in patients at high risk for contrast-induced acute kidney injury (CK-AKI), which will begin later this year.
The co-primary investigators for this study are Philippe Garot, head of Interventional Cardiology, the Insitut Cardiovasculaire Paris Sud, France, and Horst Sievert, director and founder, Cardiovascular Center (CVC) Frankfurt, Germany. The study, which is expected to enrol up to 300 patients, will be independently conducted by CERC.
RenalGuard measures a patient’s urine output and automatically infuses hydration fluid based on that urine output. The system is designed to induce high urine rates, with the intention of protecting the kidney from a range of insults.
A number of clinical trial results have demonstrated RenalGuard’s ability to protect patients from AKI following catheterisation procedures when compared to the standard of care, including:
- Protect-TAVI, which reported a significant reduction in post-procedural acute kidney injury (AKI) following transcatheter aortic valve replacement (TAVR).
- MYTHOS, which found RenalGuard to be superior to overnight hydration.
- REMEDIAL II, which found RenalGuard to be superior to sodium bicarbonate hydration.
- AKIGUARD, which reported that patients treated with RenalGuard had reduced major adverse events and hospital stays at one year when compared to standard therapy.
The company recently announced the publication of the results of an additional study that confirmed the previous clinical trial results in 400 patients.