"Vitamin D insufficiency in CKD patients is a significant problem associated with increased mortality and morbidity and for which no approved treatment is available," said Joel Z. Melnick, MD, 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).
CTAP101 Capsules are being developed as a treatment for vitamin D insufficiency and elevated PTH levels in CKD patients. The product is designed to raise serum total vitamin D pro-hormone concentrations to levels of 30 ng/mL or higher, while also lowering the risk of side effects associated with other vitamin D treatments. CTAP101 Capsules is intended to help nephrologists treat and/or prevent SHPT associated with vitamin D insufficiency.
