Cytochroma initiates CTAP101 repeat-dose safety, efficacy study in vitamin D insufficiency, SHPT and CKD

Feb 17 2011

Cytochroma today announced the initiation of a repeat-dose safety and efficacy study of CTAP101 Capsules in patients with vitamin D insufficiency, secondary hyperparathyroidism (SHPT) and stage 3 chronic kidney disease (CKD).

"Vitamin D insufficiency in CKD patients is a significant problem associated with increased mortality and morbidity and for which no approved treatment is available," stated Joel Z. Melnick, M.D., Cytochroma's Vice President, Clinical Research and Development. "Based on the positive profile observed for CTAP101 Capsules in a previous single-dose Phase 2 study, we have commenced this important repeat-dose study. We are optimistic that this study will demonstrate CTAP101 Capsules to be a more effective and reliable treatment option than currently available vitamin D supplements."

The newly initiated trial is a randomized, double-blind, placebo controlled, multi-site study designed to evaluate the safety, efficacy, pharmacokinetics, pharmacodynamics and tolerability of CTAP101 Capsules, administered at various daily doses, in approximately 60 patients.  The endpoints in this study will include vitamin D status, adverse events, physical and clinical laboratory assessments, and changes in serum calcium, phosphorus and intact parathyroid hormone (PTH).