CTAP101: Phase IIb data

A double-blind, U.S. Phase IIb trial in 78 stage III or IV CKD patients with SHPT and vitamin D insufficiency showed that once-daily 30, 60 and 90 µg oral CTAP101 significantly reduced mean intact PTH levels from baseline to week 6 by 20%, 33% and 39%, respectively, vs. a 17% increase for placebo (p<0.005 for all). Additionally, 98% of patients receiving CTAP101 achieved an increase in serum 25-hydroxyvitamin D levels to >=30 ng/mL vs. 3% for placebo. Specifically, low-, mid- and high-dose CTAP101 increased mean serum 25-hydroxyvitamin D levels to 37.3, 66.9 and 84.8 ng/mL, respectively, at week 6 vs. 18.5 ng/mL for placebo (p<0.001 for all). Baseline levels of intact PTH and 25-hydroxyvitamin D were comparable across all 4 treatment arms, with mean values ranging from 115-150 pg/mL and 20-23 ng/mL, respectively. ...