Bardoxolone methyl: Phase IIb data

A double-blind Phase IIb trial in 227 patients with moderate to severe CKD and Type II diabetes showed that once-daily bardoxolone methyl met the primary endpoint of significantly increasing mean eGFR from baseline to week 24 vs. placebo (10.1 vs. 0.1 mL/min/1.73 m2, p<0.0001). Additionally, about 60% of patients treated with bardoxolone experienced a reduction in the classification of the severity of their disease vs. 17% for placebo, and 4% of bardoxolone-treated patients experienced a worsening of their CKD stage vs. 13% for placebo. Furthermore, about 75% of bardoxolone-treated patients achieved an improvement of >=10% in their eGFR. The most common adverse event was muscle spasm, and the frequency of adverse events was higher for bardoxolone compared to placebo. Patients received once-daily 25, 75 or 150 mg bardoxolone or placebo for 24 weeks. Data were presented at the American Society of Nephrology meeting in Denver. ...