Last month, the New England Journal of Medicine published data from a phase 2 study conducted by research leaders Bruce Spinowitz, M.D., associate chairman, Department of Medicine, and associate director, Nephrology, New York Hospital Queens, assessing the effect of medication on kidney disease and diabetes. The definition of chronic kidney disease is 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.

The study revealed a sustained improvement in kidney function in patients with moderate to severe kidney disease and type 2 diabetes, receiving bardoxolone methyl (antioxidant inflammation modulator) for one year. Bardoxolone methyl is an inflammation suppressant and reduces oxidative stress that can damage cells.

Dr. Spinowitz said:

"In the United States, there are more than 26 million patients with chronic kidney disease. 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, a multi-center trial called BEACON, which will study the medication's impact on clinical outcomes.

Researchers, including Dr. Spinowitz and his colleagues, propose to enroll approximately 1,600 patients with kidney disease and type-2 diabetes at more than 300 sites worldwide.

Interested patients wanting to enquire if they are eligible to enroll for this study should discuss this option with their physician. Additional information is available at ClinicalTrials.

Patients who need a physician, should go to "Find a Doctor" on www.nyhq or call the New York Hospital Queens' physician referral line at (800) 282-6684.

Results from the study, sponsored by Reata Pharmaceuticals, the company that retains exclusive rights to bardoxolone methyl in the U.S.
 are anticipated in 2013.

A clinical trial is a scientific study that evaluates the safety and effectiveness of medical treatments, drugs or devices as 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 an affiliate of the Weill Medical College of Cornell University.

Petra Rattue

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