Abbott’s Phase II Kidney Drug Shows Promise

Abbott achieved positive results from a Phase II dose-ranging study of atrasentan, a highly selective endothelin A receptor antagonist in development to help slow chronic kidney disease (CKD) progression in patients with type 2 diabetic kidney disease. Results suggest that atrasentan, used with renin-angiotensin system (RAS) inhibitors, may reduce the presence of protein in urine for patients with type 2 diabetes. Albuminuria is the main sign of diabetic nephropathy and as kidney function decreases, the level of albumin in the urine rises.

The eight-week study of three doses of atrasentan (0.25 mg, 0.75 mg, and 1.75 mg) vs. placebo showed atrasentan significantly reduced urine albumin-to-creatinine ratio (UACR) in the 0.75 mg and 1.75 mg groups vs. placebo. Reduction from baseline to final UACR was 21%, 42%, and 34% in the 0.25 mg, 0.75 mg and 1.75 mg groups vs. 11% in placebo, respectively. Also, a statistically significant proportion of subjects achieved greater than 40% reduction in UACR from baseline in the 0.75 mg group vs. placebo. Peripheral edema (primarily mild) was the most common adverse event (14%, 18% and 46% for 0.25, 0.75 and 1.75 mg vs. 9% in placebo).

“The impact of chronic kidney disease is a growing global public health concern but few advancements in treatment have been made in the last decade that positively affect outcomes for patients with this progressive disease,” said James Stolzenbach, Ph.D., divisional vice president, Dyslipidemia and Renal, Abbott. “Longer, outcome-driven clinical trials are needed to establish the safety and efficacy of atrasentan in diabetic nephropathy, but we are encouraged by the findings from this study and look forward to further evaluating atrasentan as a candidate for treating this type of chronic kidney disease.”