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ARTICLE | Clinical News

Auryxia: Phase III data

April 4, 2016 7:00 AM UTC

Top-line data from a double-blind, U.S. Phase III trial in 234 stage 3-5 non-dialysis-dependent CKD patients who did not adequately respond to or tolerate current oral iron therapies showed that oral Auryxia met the primary endpoint of a greater proportion of patients achieving a >=1 g/dL increase in hemoglobin at any point during the 16-week efficacy period vs. placebo (52.1% vs. 19.1%, p<0.001). Auryxia also met the secondary endpoints of improving mean hemoglobin (increase of 0.75 g/dL vs. a reduction of 0.08 g/dL, p<0.001), TSAT (increase of 17.8% vs. a reduction of 0.6%, p<0.001), ferritin (increase of 162.5 ng/mL vs. a reduction of 7.7 ng/mL, p<0.001) and serum phosphate levels (reduction of 0.43 mg/dL vs. a reduction of 0.22 mg/dL, p=0.02) and the rate of durable response (48.7% vs. 14.8%, p<0.001) vs. placebo. The trial includes an 8-week open-label safety extension period in which all patients receive Auryxia. ...