Cytochroma starts Phase I/II trial for kidney disease drug

This Phase I/II trial is a four-week, open label study designed to establish the pharmacokinetic profile and safety of CTAP101 capsules in subjects with vitamin D insufficiency. The product’s pharmacokinetic profile will be characterized at low-, mid- and high-dosages in subjects with normal renal function, and at a single mid-dosage in subjects with stage 3 and 4 chronic kidney disease (CKD). The safety endpoints for the trial include serum and urine calcium, serum phosphorus and the serum calcium times serum phosphorus product.

CTAP101 capsules are designed to reliably boost circulating vitamin D prohormone levels to above the minimum adequate level established by the National Kidney Foundation in its kidney disease outcomes quality initiative guidelines. CTAP101 capsules can potentially help nephrologists treat or prevent secondary hyperparathyroidism which develops in most CKD patients in part because of vitamin D insufficiency.

Joel Melnick, vice president, clinical & regulatory affairs, Cytochroma, said: “CTAP101 capsules are designed specifically to address the marginal effectiveness of high-dose ergocalciferol (vitamin D(2)) in treating vitamin D insufficiency in CKD while providing a safer alternative to current off-label use of vitamin D hormone replacement therapies.”