Public Affairs and Marketing
Flushing, NY – August 10, 2011 – Chronic kidney disease is a progressive loss of kidney function over a period of months or years that can be caused by a number of conditions, including diabetes and high blood pressure. Bruce Spinowitz, M.D., associate chairman, Department of Medicine, and associate director, Nephrology, New York Hospital Queens, served as a principal investigator in a phase 2 study of a medication’s effect on kidney disease and diabetes.
Data from this phase 2 study was published in the New England Journal of Medicine last month. The study showed that patients with moderate to severe kidney disease and type 2 diabetes who received bardoxolone methyl for one year experienced a sustained improvement in kidney function. Bardoxolone methyl is an antioxidant inflammation modulator, which means it reduces oxidative stress (which can damage cells) and suppresses inflammation.
“In the United States, there are more than 26 million patients with chronic kidney disease,” said Dr. Spinowitz. “The next phase of this study will assess whether bardoxolone methyl is effective in delaying the progression to end-stage kidney disease and cardiovascular deaths in patients with stage 4 kidney disease and type 2 diabetes.”
The study recently entered phase 3, which will study the medication’s impact on clinical outcomes. Phase 3 is a multi-center trial, called BEACON. The study plans to enroll approximately 1,600 patients with kidney disease and type 2 diabetes at more than 300 sites worldwide. Dr. Spinowitz and his associates are participating in this study.
Patients who are interested in finding out if they are eligible to enroll for this study should discuss this option with his/her physician. Additional information is available at ClinicalTrials.gov. Patients who need a physician, should go to “Find a Doctor” on www.nyhq.org or call the New York Hospital Queens’ physician referral line at (800) 282-6684.
Results from the study are expected in 2013. The study is sponsored by Reata Pharmaceuticals, the company that retains exclusive rights to bardoxolone methyl in the U.S.
A clinical trial is a scientific study that evaluates the safety and effectiveness of medical treatments, drugs or devices. These are required by the U.S. Federal Drug Administration (FDA) for manufacturers to earn approval to commercialize new products and new uses for existing products.
New York Hospital Queens is a member of the NewYork-Presbyterian Healthcare System and is an affiliate of the Weill Medical College of Cornell University.