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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

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  • A more than 30 percent albuminuria reduction was observed in 51 and 55 percent of the atrasentan subjects, respectively (P=0.001).ii
  • Changes in estimated glomerular filtration rate (eGFR), another important measure of kidney function, were measured  compared to placebo in both groups (0.75mg= -0.81/min/1.73m2; p=0.412 and 1.25mg= -0.91 ml/min/1.73m2; p=0.355), and did not change significantly compared to placebo.ii
  • In the Phase 2b studies, the observed adverse events were similar among the three treatment and placebo groups.  The most commonly observed adverse events included peripheral edema (35 percent in 0.75mg arm, 42 percent in 1.25 mg arm vs. 42 percent on placebo), diarrhea and constipation (13 percent in 0.75mg arm, 21 percent in 1.25 mg arm vs. 14 percent on placebo).  There were no significant differences in the rate of peripheral edema or diarrhea and constipation among the treatment and placebo arms.ii 

    A small percentage of subjects discontinued the study due to adverse events (8 percent on 0.75 mg, 15 percent on 1.25mg vs. 0 on placebo), with edema as the most commonly cited reason.ii

    Importantly, the study concluded that the 0.75 mg dose of atrasentan administered orally once daily showed the best efficacy-safety balance, informing the dosing of atrasentan selected for further investigation in the Phase 3 clinical study.ii

    About SONAR Study

    SONAR is a randomized, double-blind, parallel, placebo-controlled, multicenter study designed to assess the effects of atrasentan (0.75 mg administered orally once a day) on renal outcomes in patients with type 2 diabetic nephropathy (diabetic kidney disease) while they continue to be treated with the current standard of care: the maximum tolerated labeled daily dose of a RAS inhibitor, such as an ACE inhibitor or an ARB, and a diuret
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