OPKO Health OPK, has completed patient recruitment in the
second 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
second 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
See full press release
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