Phase 2 study of atrasentan for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes

Abbott announced results from its Phase 2 trial of atrasentan to help slow chronic kidney disease (CKD) progression in patients with type 2 diabetic nephropathy (diabetic kidney disease). The study was a double-blind, dose-ranging, placebo-controlled study of 89 patients with diabetic nephropathy on stable doses of renin-angiotensin system (RAS) inhibitors for >2 months with urinary albumin-to-creatinine ratio (UACR) of 100-3000 mg/g, eGFR >20 mL/min/1.73m2, and NT-pro-BNP <500 pg/mL. Patients were equally randomized to placebo, atrasentan 0.25, 0.75, or 1.75mg daily for 8 weeks. The study's primary endpoint was mean change in UACR ratio from baseline to each treatment visit. The secondary endpoint was measured as the proportion of subjects achieving at least a 40% reduction in final UACR levels from baseline.

Atrasentan significantly reduced urine albumin-to-creatinine ratio (UACR) in the 0.75 and 1.75mg groups vs. placebo (P=0.001 and P=0.011 by repeated measures, respectively). The 0.25mg dose had no significant effect.  Additionally, the study demonstrated a reduction from baseline to final UACR was 21%, 42%, and 34% in the 0.25, 0.75 and 1.75mg groups vs. 11% in placebo (P=0.292, P=0.023 and P=0.080, respectively).  A statistically significant proportion of subjects achieved >40% reduction in UACR from baseline in the 0.75mg group vs. placebo (50% vs. 17% respectively, P=0.029). The proportion of patients in the 0.25 and 1.75mg groups (30% and 38% respectively) did not reach statistical significance.

Atrasentan is an investigational compound belonging to a class of compounds known as selective endothelin-A receptor antagonists, which block the effect of endothelin-l (ET-l), a protein that constricts blood vessels and raises blood pressure that impact kidney functions.

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