Cytochroma announced initiation of its Phase 2b study of CTAP101 capsules for the treatment of patients with vitamin D insufficiency, secondary hyperparathyroidism (SHPT), and stage 3 CKD. This trial is a randomized, double-blind, placebo-controlled, multisite study designed to evaluate the safety, efficacy, pharmacokinetics, pharmacodynamics and tolerability of CTAP101 capsules, administered at various daily doses, in approximately 60 patients. The efficacy endpoints include vitamin D status, adverse events, physical and clinical laboratory assessments, and changes in serum calcium, phosphorus and intact parathyroid hormone (PTH).

CTAP101 is designed to reliably raise serum total vitamin D pro-hormone concentrations to levels of 30ng/mL or higher, while also lowering the risk of side effects associated with other vitamin D treatments.

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