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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

in the developed world.  In the US, approximately 40 percent of patients with diabetes develop diabetic nephropathy.  Albuminuria - protein in the urine, as measured by urine albumin-to-creatinine ratio (UACR) - is the main sign of diabetic nephropathy.iii As kidney function decreases, the level of protein in the urine rises, leading to further damage to the kidney.iv Previous research has suggested that endothelin receptors play a role in this process and drugs that target this receptor system, such as atrasentan, may have the potential to delay progression of CKD.i

"We are committed to improving renal outcomes for patients with type 2 diabetes, where there is significant unmet need," said James Stolzenbach , Ph.D., divisional vice president, dyslipidemia and renal, AbbVie.  "If validated in Phase 3, atrasentan has the potential to provide a novel treatment option for type 2 diabetic kidney disease patients worldwide."

About Phase 2b Studies

The Phase 2b studies of atrasentan were conducted to evaluate the efficacy and safety of atrasentan in lowering albuminuria in subjects with type 2 diabetes and nephropathy receiving maximum tolerated labeled doses of angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB).  Two parallel, double-blind, placebo-controlled, multinational studies were conducted: one in Japan with 58 patients and a second in the US, Canada and Taiwan with 153 patients.  Findings from the 12-week studies of two doses of atrasentan (0.75 mg, n=78; 1.25 mg, n=83) vs. placebo (n=50) showed sustained reductions in UACR (primary endpoint): 36 percent in the 0.75 mg, 44 percent in 1.25 mg group vs. increase of 2 percent in placebo group (P<0.001).ii

Additionally, as secondary endpoints:


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