European STRENGTH Trial Will Evaluate Long-Term Impact of RenalGuard Therapy in Patients at High Risk for CI-AKI

January 26, 2016—RenalGuard Solutions, Inc. announced that the STRENGTH trial will begin later this year. The trial is designed to evaluate the long-term clinical and economic impact of RenalGuard therapy in patients at high risk for contrast-induced acute kidney injury (CI-AKI). 

Philippe Garot, MD, and Prof. Horst Sievert, MD, are the Coprimary Investigators for the STRENGTH study. Dr. Garot is Head of Interventional Cardiology at the Institut Cardiovasculaire Paris Sud in France. Prof. Sievert is Director and Founder of the CardioVascular Center in Frankfurt, Germany. The study, which is expected to enroll up to 300 patients, will be independently conducted by CERC, the Cardiovascular European Research Center.

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, which have been shown to protect the kidney from a range of insults. RenalGuard has received CE Mark approval and is commercially available in Europe and certain countries around the world.

The CIN-RG RenalGuard pivotal study is underway in the United States to support a planned premarket approval filing with the US Food and Drug Administration.

The company stated that a number of clinical trial results have demonstrated RenalGuard's ability to protect patients from AKI after catheterization procedures when compared to the standard of care. 

As reported in September 2015, Marco Barbanti, MD, et al published findings from the PROTECT-TAVI study in the Journal of the American College of Cardiology: Cardiovascular Interventions (2015;8:1595–1604). The investigators concluded that the RenalGuard is an effective therapeutic tool that can be used to reduce the occurrence of AKI in patients undergoing transcatheter aortic valve replacement.

On January 21, RenalGuard Solutions announced that findings of an investigator-sponsored study confirmed the previous clinical trial results of the use of RenalGuard in normal clinical use to protect patients who were at high risk of developing CI-AKI. Carlo Briguori, MD, et al published the study in the American Heart Journal (2016;173:67–76). 

The study evaluated the use of RenalGuard in 400 patients treated in the course of normal clinical use of RenalGuard at the clinic. It reported that RenalGuard therapy is safe and effective at enabling patients to reach target urine rates. The study also found that patients who reached a urine flow rate ≥ 450 mL/h during their catheterization saw the greatest protection from CI-AKI. Patients who did not reach the intraprocedural urine flow rate of 450 mL/h had an increased hazard ratio for developing CI-AKI of 2.27 (95% confidence interval, 1.05–2.01; P = .012) compared to those who did. This further validates the value of RenalGuard therapy’s ability to safely induce high urine flow rates as a protective measure against CI-AKI, stated the company.

On January 4, the company announced that the AKIGUARD study reported that patients treated with RenalGuard had reduced major adverse events and hospital stays at 1 year when compared to standard therapy. Tullio Usmiani, MD, et al published the findings online ahead of print in the Journal of Cardiovascular Medicine.

Additionally, the MYTHOS study found RenalGuard to be superior to overnight hydration, and REMEDIAL II found RenalGuard to be superior to sodium bicarbonate hydration, advised the company.