RenalGuard Clinical Investigations are conducted using RenalGuard Therapy® and RenalGuard System™.
For more information, please contact ClinicalInvestigations@renalguard.com.
(US Pivotal Trial)
|Charles Davidson, MD
Richard J. Solomon, MD
Roxana Mehran, MD
|Study the efficacy of RenalGuard Therapy and RenalGuard System compared to the current standard of care.||Currently enrolling patients|
|REMEDIAL II||Carlo Briguori, MD||Study the efficacy of RenalGuard Therapy compared to the current standard of care.||RenalGuard Therapy is superior to sodium bicarbonate and N-acetylcysteine in preventing contrast-induced acute kidney injury in high-risk patients.|
|MYTHOS||Antonio Bartorelli, MD
Giancarlo Marenzi, MD
|Compare the rates of CIN in at-risk patient who receive induced diuresis with automated matched hydration therapy utilizing RenalGuard, compared to patients who receive standard overnight hydration.||Patients who were at higher risk for renal failure and who were treated with RenalGuard while undergoing imaging procedures developed CIN at a rate 74% lower than those who were treated with overnight hydration.|
US Pilot Study
|Fred Resnic, MD||Study the performance and safety of RenalGuard||The study confirmed that the RenalGuard system is safe and dynamically balances volume hydration with urine production.|
In October 2011, we received final approval from the FDA to commence the CIN-RG trial, its U.S. pivotal trial to study the efficacy of RenalGuard Therapy® and RenalGuard System™ compared to the current standard of care.
The CIN-RG trial is under the supervision of Principal Investigators Charles Davidson, MD, Professor of Medicine, Northwestern University Medical School, Richard J. Solomon, MD, Professor of Medicine, University of Vermont College of Medicine and Roxana Mehran, MD, Professor of Medicine at Mount Sinai School of Medicine. It is designed as an adaptive, randomized controlled trial at up to 30 sites in the U.S. Enrollment in the trial 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, often used in adaptive trials, enables investigators to ensure that the trial is sufficiently powered so that the final results are statistically meaningful.
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.
MYTHOS is an investigator-sponsored, randomized clinical trial designed to evaluate the effectiveness of RenalGuard Therapy® at reducing the incidence of Contrast-Induced Nephropathy (CIN). The study compares the rates of CIN in at-risk patient who receive induced diuresis with automated matched hydration therapy utilizing RenalGuard, compared to patients who receive standard overnight hydration. Final results were published in January 2012 in JACC - Cardiovascular Interventions.
Dr. Antonio Bartorelli and Dr. Giancarlo Marenzi, the principal investigators for the trial, reported on data from 170 patients with chronic kidney disease (CKD) who underwent elective or urgent percutaneous coronary interventions (PCI) in Italy. The results indicate that patients who were at higher risk for renal failure and who were treated with RenalGuard while undergoing imaging procedures developed CIN at a rate 74% lower than those who were treated with overnight hydration. The trial also found that patients treated with RenalGuard had significantly fewer in-hospital adverse events than those treated with overnight hydration.
A Pilot Study was conducted in four clinical sites in the U.S. with a total of 23 patients enrolled in the study. The Study was designed to evaluate the safety of RenalGuard System and RenalGuard Therapy, under an Investigational Device Exemption (IDE) approved by the U.S. Food and Drug Administration (FDA). The results were presented at the American College of Cardiology, March 2009, and published in the International Journal of Cardiology in December 2011.
RenalGuard is CE-marked for the intended use of temporary (up to 14 days) replacement of urine output by infusion of a matched volume of sterile replacement solution to maintain a patient’s intravascular fluid volume. The RenalGuard System is not intended for infusion of blood, blood components, medications, or nutritional fluids. All treatments administered via The RenalGuard System must be prescribed by a physician. RenalGuard Solutions, Inc. reserves the right to modify the specifications and features described herein, or discontinue manufacture of the product described at any time without prior notice or obligation.
Limited by US Law to Investigational Use only in the US.