Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in Hemodialysis and peritoneal dialysis: A randomized, double-blind, multicenter study

Management of secondary hyperparathyroidism is challenging with traditional therapy. The calcimimetic cinacalcet HCI acts on the calcium-sensing receptor to increase its sensitivity to calcium, thereby reducing parathyroid hormone (PTH) secretion. This phase 3, multicenter, randomized, placebo-controlled, double-blind study evaluated the efficacy and safety of cinacalcet in hemodialysis (HD) and peritoneal dialysis (PD) patients with PTH greater than or equal to 300 pg/ml despite traditional therapy. A total of 395 patients received once-daily oral cinacalcet (260 HD, 34 PD) or placebo (89 HD, 12 PD) titrated from 30 to 180 mg to achieve a target intact PTH (iPTH) level of less than or equal to 250 pg/ml. During a 10-wk efficacy assessment phase, cinacalcet was more effective than control for PTH reduction outcomes, including proportion of patients with mean iPTH levels less than or equal to 300 pg/ml (46 versus 9%), proportion of patients with greater than or equal to 30% reduction in iPTH from baseline (65 versus 13%), and proportion of patients with greater than or equal to 20, greater than or equal to 40, or greater than or equal to 50% reduction from baseline. Cinacalcet had comparable efficacy in HD and PD patients; 50% of PD patients achieved a mean iPTH less than or equal to 300 pg/ml. Cinacalcet also significantly reduced serum calcium, phosphorus, and Ca x P levels compared with control treatment. The most common side effects, nausea and vomiting, were usually mild to moderate in severity and transient. Once-daily oral cinacalcet was effective in rapidly and safely reducing PTH, Ca x P, calcium, and phosphorus levels in patients who received HD or PD. Cinacalcet offers a new therapeutic option for controlling secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.