Abbott Laboratories’ atrasentan has shown promise in a Phase II trial in patients with diabetic kidney disease, with data indicating that it could be a useful tool in helping to slow down progression of the illness.
Results from the Phase II dose-ranging study of atrasentan suggest that adding it to therapy with renin-angiotensin system (RAS) inhibitors could help reduce albuminuria – the presence of protein in urine and a primary marker for diabetic nephropathy – in patients with type II diabetes.
Headline results of the double-blind trial, which involved 89 patients, showed significant reductions in the albumin-to-creatinine ratio (UACR) in two of the three doses of atrasentan tested – the 0.75mg and 1.75mg strengths – compared to placebo.
In addition, a statistically significant proportion of subjects achieved a greater than 40% reduction in UACR from baseline in the 0.75mg group compared to the control (50% versus 17%, respectively), a secondary endpoint of the trial, but the other doses failed to reach statistical significance, the firms said.
Commenting on the findings, which were presented at the annual American Society of Nephrology meeting this week, lead study investigator Donald Kohan, Professor of Medicine at the University of Utah Health Sciences Center, said the results are “encouraging” and that atrasentan “may have an additional therapeutic role for albuminuria reduction on top of the current standard of care for patients with type 2 diabetes”.
“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,” added James Stolzenbach, divisional vice president of Abbott’s Dyslipidemia and Renal division.
