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Published ahead of print on February 2, 2005
J Am Soc Nephrol 16: 800-807, 2005
© 2005 American Society of Nephrology
doi: 10.1681/ASN.2004060512
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Human Mineral Metabolism and Bone Disease

Cinacalcet HCl, an Oral Calcimimetic Agent for the Treatment of Secondary Hyperparathyroidism in Hemodialysis and Peritoneal Dialysis: A Randomized, Double-Blind, Multicenter Study

Jill S. Lindberg*, Bruce Culleton{dagger}, Gordon Wong{ddagger}, Michael F. Borah§, Roderick V. Clark||, Warren B. Shapiro, Simon D. Roger**, Fred E. Husserl*, Preston S. Klassen{dagger}{dagger}, Matthew D. Guo{dagger}{dagger}, Moetaz B. Albizem{dagger}{dagger} and Jack W. Coburn{ddagger}{ddagger},a

* Ochsner Clinic Foundation and New Orleans Nephrology Associates New Orleans, Louisiana; {dagger} Foothills Hospital, Calgary, Alberta, Canada; {ddagger} Credit Valley Hospital, Mississauga, Ontario, Canada; § California Pacific Medical Center, San Francisco, California; || Our Lady of Lourdes RMC, Lafayette, Louisiana; Brookdale Plaza Nephrology Associates, Brooklyn, New York; ** Gosford Hospital, Gosford, New South Wales, Australia; {dagger}{dagger} Amgen Inc., Thousand Oaks, California; and {ddagger}{ddagger} VA Greater Los Angeles Healthcare System and David Geffen School of Medicine at UCLA, Los Angeles, California

Address correspondence to: Dr. Jill S. Lindberg, New Orleans Nephrology Associates, 4228 Houma Boulevard, Metairie, LA 70006. Phone: 504-457-3687; Fax: 504-456-5082; E-mail: jlindberg{at}bellsouth.net

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 ≥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 ≤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 ≤300 pg/ml (46 versus 9%), proportion of patients with ≥30% reduction in iPTH from baseline (65 versus 13%), and proportion of patients with ≥20, ≥40, or ≥50% reduction from baseline. Cinacalcet had comparable efficacy in HD and PD patients; 50% of PD patients achieved a mean iPTH ≤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.


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