OPKO Health Completes Patient Recruitment In First Phase 3 Trial Of Rayaldy

(RTTNews) - OPKO Health Inc. (OPK) announced it has completed patient recruitment in the first phase 3 trial of Rayaldy to treat patients with secondary hyperparathyroidism, stage 3 or 4 chronic kidney disease and vitamin D insufficiency.

The trial is the first of two identical randomized, double-blind, placebo-controlled, multi-site studies intended to establish the safety and efficacy of Rayaldy as a new treatment for secondary hyperparathyroidism 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. Each of the two pivotal phase 3 trials involves approximately 210 patients. 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 Rayaldy.