Research-based biopharmaceutical company AbbVie has started Phase 3 in study of investigational compound atrasentan on renal outcomes in patients with diabetic nephropathy.
The ‘Study Of Diabetic Nephropathy with Atrasentan’ (SONAR) is designed to 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 (CKD) and type 2 diabetes.
The SONAR steering committee co-chair chair Dick de Zeeuw said there was 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," de Zeeuw said.
The multinational, double-blind, placebo-controlled study will enrol more than 4,000 patients with diabetic nephropathy.
The atrasentan’s impact on renal outcomes, including the onset of end-stage renal disease (ESRD), as defined by need for chronic dialysis, transplant or death due to renal failure progression, will be assessed.
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."
Image: Nodular glomerulosclerosis in the kidney of a patient with diabetic nephropathy. Photo: courtesy of CDC.