OPKO Health, Inc. (NYSE:OPK), has completed patient recruitment in the first phase 3 trial of RayaldyTM to treat patients with secondary hyperparathyroidism (SHPT), stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. This trial is the first of two identical randomized, double-blind, placebo-controlled, multi-site studies intended to establish the safety and efficacy of RayaldyTM as a new treatment for SHPT in the targeted population. The endpoints of both studies, which are being conducted in parallel, include vitamin D status and changes in serum calcium, serum phosphorus and plasma intact parathyroid hormone (PTH).
Each of the two pivotal phase 3 trials involves approximately 210 patients recruited at approximately 40 sites in the United States (U.S.). Patients are being stratified by CKD stage and randomized in a 2:1 fashion to receive six months of treatment with either RayaldyTM or placebo. Top-line data from both trials are expected in mid-2014.
The two pivotal trials are being followed by an open-label extension study in which patients are treated, at their election, for an additional 6 months with RayaldyTM. To date, 129 patients have enrolled in this open-label study.