Additional Relevant Details
The data showed that RAYALDEE has similar effectiveness and safety in controlling SHPT in both African-American (AA) and non-African-American(nAA) patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency (defined as serum total 25-hydroxyvitamin D levels less than 30 ng/mL). Serum total 25-hyrdroxyvitamin D levels showed a similar increase in both patient populations beyond the target of 30 ng/mL, a level considered sufficient for CKD patients in published clinical practice guidelines, despite the well established tendency for lower levels in AA patients. Plasma intact parathyroid hormone (iPTH) levels were effectively suppressed by RAYALDEE in AA patients and nAA patients versus placebo treatment.