Cytochroma Initiates Phase 3 Study of CTAP101 Capsules in Chronic Kidney Disease Patients

Cytochroma Initiates Phase 3 Study of CTAP101 Capsules in Chronic Kidney Disease Patients PR Newswire MARKHAM, Ontario, September 20, 2012 MARKHAM, Ontario, September 20, 2012 /PRNewswire/ -- Cytochroma today announced the initiation of a phase 3 study of CTAP101 capsules ("CTAP101 Capsules") in patients with secondary hyperparathyroidism (SHPT), stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. The newly initiated trial is the first of two identical randomized, double-blind, placebo controlled, multi-site studies intended to establish the safety and efficacy of CTAP101 Capsules as a new treatment for SHPT in the targeted population. The endpoints of both studies, which will be conducted in parallel, include vitamin D status, adverse events, physical and clinical laboratory assessments, and changes in serum calcium, serum phosphorus and plasma intact parathyroid hormone (PTH). "Secondary hyperparathyroidism develops in CKD patients due to vitamin D insufficiency or declining kidney function," explained Joel Z. Melnick, M.D., Cytochroma's Vice President, Clinical Research and Development. "Most CKD patients have insufficient stores of vitamin D due to the abnormal upregulation of CYP24, an enzyme which specifically destroys vitamin D and its metabolites. Many recent studies in CKD patients have demonstrated that over-the-counter and prescription vitamin D supplements cannot reliably raise blood vitamin D prohormone levels or effectively treat SHPT.