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Published ahead of print on February 2, 2005
Journal of the American Society of Nephrology
© 2005 American Society of Nephrology
doi: 10.1681/ASN.2004060512
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CLINICAL SCIENCE: 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 1*, Bruce Culleton 2, Gordon Wong 3, Michael F. Borah 4, Roderick V. Clark 5, Warren B. Shapiro 6, Simon D. Roger 7, Fred E. Husserl 1, Preston S. Klassen 8, Matthew D. Guo 8, Moetaz B. Albizem 8, Jack W. Coburn 9

1

*Ochsner Clinic Foundation and New Orleans Nephrology Associates New Orleans, Louisiana


2

{dagger}Foothills Hospital, Calgary, Alberta, Canada


3

{ddagger}Credit Valley Hospital, Mississauga, Ontario, Canada


4

{sect}California Pacific Medical Center, San Francisco, California


5

||Our Lady of Lourdes RMC, Lafayette, Louisiana


6

Brookdale Plaza Nephrology Associates, Brooklyn, New York


7

**Gosford Hospital, Gosford, New South Wales, Australia


8

{dagger}{dagger}Amgen Inc., Thousand Oaks, California


9

{ddagger}{ddagger}VA Greater Los Angeles Healthcare System and David Geffen School of Medicine at UCLA, Los Angeles, California


* To whom correspondence should be addressed. E-mail: jlindberg{at}bellsouth.net.


  Abstract

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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