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news.AbbVie has begun Phase 3 study of atrasentan on renal outcomes including the onset of end-stage renal disease (ESRD) transplant or death due to renal failure progression in patients with diabetic nephropathy.
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The Study Of Diabetic Nephropathy with Atrasentan (SONAR) will assess the effects of atrasentan upon addition to standard of care on progression of kidney disease in patients with stage 2 to 4 chronic kidney disease and type 2 diabetes.
The SONAR steering committee co-chair and the University of Groningen, the Netherlands, department of clinical pharmacology and department of nephrology professor and chair Dick de Zeeuw said there is an urgent need to find new medications for nephropathy in patients with type 2 diabetes with high risk to end up in dialysis.
"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," Dick de Zeeuw added.
More than 4,000 patients with diabetic nephropathy will be enrolled in the multinational, double-blind, placebo-controlled study.
AbbVie dyslipidemia and renal divisional vice president James Stolzenbach said, "If validated in Phase 3, atrasentan has the potential to provide a novel treatment option for type 2 diabetic kidney disease patients worldwide."