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AbbVie Initiates Phase 3 Study of Its Investigational Compound Atrasentan on Renal Outcomes in Patients with Diabetic Nephropathy
Date:5/20/2013

NORTH CHICAGO, Ill., May 20, 2013 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today the initiation of a Phase 3 clinical study called SONAR (Study Of Diabetic Nephropathy with Atrasentan) to assess the effects of the investigational compound atrasentan - when added to standard of care - on progression of kidney disease in patients with stage 2 to 4 chronic kidney disease (CKD) and type 2 diabetes.  SONAR is a large, multinational, double-blind, placebo-controlled clinical study that is expected to enroll more than 4,000 patients with diabetic nephropathy.  The study will evaluate atrasentan's impact on renal outcomes, such as the onset of end-stage renal disease (ESRD), as defined by need for chronic dialysis, transplant or death due to renal failure progression.i

The initiation of the Phase 3 study follows results from Phase 2b studies, which were presented today during a late breaking clinical trials scientific session at the 2013 European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress in Istanbul, Turkey.ii

"There is a pressing need for new medications to treat nephropathy in patients with type 2 diabetes, who have a high risk to end up in dialysis," said Dick de Zeeuw , M.D., Ph.D., Professor and Chair of the Department of Clinical Pharmacology and Department of Nephrology at the University of Groningen, the Netherlands, and Co-Chair of the SONAR steering committee. "Phase 2 studies of atrasentan in this patient population have shown encouraging results, and we look forward to further evaluating this investigational treatment in the Phase 3 SONAR study."

Diabetic nephropathy, or diabetic kidney disease, is a common complication of diabetes and the leading cause of CKD
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