Simultaneous control of PTH and CaxP Is sustained over three years of treatment with cinacalcet HCl

Clin J Am Soc Nephrol. 2009 Sep;4(9):1465-76. doi: 10.2215/CJN.06141108. Epub 2009 Aug 20.


Background & objectives: Chronic kidney disease (CKD) is commonly complicated by secondary hyperparathyroidism (SHPT), leading to increased risk of morbidity and mortality. SHPT is a progressive disease often requiring long-term therapy to control parathyroid hormone (PTH) and mineral imbalances. Vitamin D sterols and phosphate binders, used as traditional therapies to lower PTH and phosphorus, may provide inadequate long-term control for many dialysis patients. Cinacalcet, by simultaneously lowering PTH, calcium, phosphorus, and calcium-phosphorus levels, may maintain PTH and mineral balance in these individuals. However, as with traditional therapies, long-term data are limited. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENT: Dialysis subjects from at least one of five lead-in studies (double-blind placebo-controlled, including one extension trial) completing up to 52 wk of either cinacalcet or placebo were eligible for this open-label extension study, including an 8-wk dose titration (initiated at 30 mg/d), followed by 24-wk maintenance and up to 132 wk of follow-up. Final efficacy analysis was at week 180.

Results: Three hundred thirty-four of 589 enrolled subjects received cinacalcet from the beginning of the lead-in study. Weekly median PTH values were < or =300 pg/ml (weeks 16 through 180) and median CaxP values were < or =55 mg(2)/dl(2) (weeks 4 through 180). Similar results were exhibited in the 255 subjects who initially received placebo. Among the patients exposed to cinacalcet from the beginning of the lead-in study, 3% of subjects exhibited treatment-related serious adverse events.

Conclusions: Cinacalcet effectively maintained PTH, Ca and P reductions in dialysis subjects for up to 180 wk.

Publication types

  • Controlled Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Biomarkers / blood
  • Calcium / blood*
  • Canada
  • Chelating Agents / therapeutic use
  • Chronic Disease
  • Cinacalcet
  • Double-Blind Method
  • Drug Therapy, Combination
  • Europe
  • Female
  • Humans
  • Hyperparathyroidism, Secondary / blood
  • Hyperparathyroidism, Secondary / drug therapy*
  • Hyperparathyroidism, Secondary / etiology
  • Kidney Diseases / blood
  • Kidney Diseases / complications
  • Kidney Diseases / drug therapy
  • Kidney Diseases / therapy*
  • Male
  • Middle Aged
  • Naphthalenes / adverse effects
  • Naphthalenes / therapeutic use*
  • Parathyroid Hormone / blood*
  • Peritoneal Dialysis*
  • Phosphates / blood
  • Phosphorus / blood*
  • Renal Dialysis*
  • Time Factors
  • Treatment Outcome
  • United States
  • Vitamin D / therapeutic use


  • Biomarkers
  • Chelating Agents
  • Naphthalenes
  • Parathyroid Hormone
  • Phosphates
  • Vitamin D
  • Phosphorus
  • Calcium
  • Cinacalcet