AbbVie inc. (ABBV) said Monday that it has inititated a Phase 3 clinical study called SONAR 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 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, as defined by need for chronic dialysis, transplant or death due to renal failure progression.
The initiation of the Phase 3 study follows results from Phase 2b studies, which were presented Friday during a late breaking clinical trials scientific session at the 2013 European Renal Association-European Dialysis and Transplant Association Congress in Istanbul, Turkey.
Diabetic nephropathy, or diabetic kidney disease, is a common complication of diabetes and the leading cause of chronic kidney disease in the developed world. In the US, about 40% of patients with diabetes develop diabetic nephropathy.
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