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

• Published in: Journal of the American Society of Nephrology Vol. 16; no. 3; pp. 800 - 807
• Main Authors: LINDBERG, Jill S, CULLETON, Bruce, ALBIZEM, Moetaz B, COBURN, Jack W, WONG, Gordon, BORAH, Michael F, CLARK, Roderick V, SHAPIRO, Warren B, ROGER, Simon D, HUSSERL, Fred E, KLASSEN, Preston S, GUO, Matthew D
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 01.03.2005
• Subjects: Administration, Oral; Adult; Biological and medical sciences; Calcium - blood; Cinacalcet Hydrochloride; Double-Blind Method; Drug Therapy, Combination; Endocrinopathies; Female; Humans; Hyperparathyroidism, Secondary - blood; Hyperparathyroidism, Secondary - drug therapy; Hyperparathyroidism, Secondary - etiology; Kidney Failure, Chronic - complications; Kidney Failure, Chronic - therapy; Male; Medical sciences; Middle Aged; Naphthalenes - administration & dosage; Nephrology. Urinary tract diseases; Non tumoral diseases. Target tissue resistance. Benign neoplasms; Parathyroid Hormone - blood; Parathyroids. Parafollicular cells. Cholecalciferol. Phosphocalcic homeostasis (diseases); Peritoneal Dialysis; Phosphorus - blood; Renal Dialysis; Vitamin D - administration & dosage; Endocrinopathy; Human; Nephrology; Hemodialysis; Multicenter study; Oral administration; Peritoneal dialysis; Urology; Extrarenal dialysis; Chemotherapy; Randomization; Treatment; Parathyroid diseases; Double blind study; Complication; Cinacalcet; Hyperparathyroidism
• ISSN: 1046-6673; 1533-3450
• DOI: 10.1681/ASN.2004060512

Management of secondary hyperparathyroidism is challenging with traditional therapy. The calcimimetic cinacalcet HCl 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 > or =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 < or =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 < or =300 pg/ml (46 versus 9%), proportion of patients with > or =30% reduction in iPTH from baseline (65 versus 13%), and proportion of patients with > or =20, > or =40, or > or =50% reduction from baseline. Cinacalcet had comparable efficacy in HD and PD patients; 50% of PD patients achieved a mean iPTH < or =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.