An open-label study to evaluate a single-dose of cinacalcet in pediatric dialysis subjects

Desmond Padhi*, Craig B. Langman, Sahar Fathallah-Shaykh, Bradley A. Warady, Isidro B. Salusky, Edward Lee, Christine Wang, Edward Posvar

*Corresponding author for this work

Research output: Contribution to journalArticle

14 Scopus citations

Abstract

Background: There is limited knowledge of the effectiveness and safety profile of cinacalcet in pediatric patients with secondary hyperparathyroidism (sHPT) treated with dialysis. Methods: This was an open-label, single-dose study conducted on 12 pediatric subjects with chronic kidney disease treated with dialysis. Subjects were stratified by four age cohorts and given a single 15-mg oral dose of cinacalcet. Multiple blood samples were collected up to 72 h post-dose for the assessment of serum calcium (Ca), serum intact parathyroid hormone (iPTH), and plasma cinacalcet concentrations. Results: Overall, cinacalcet was well tolerated with no serious adverse events. Mean (standard deviation) percentage change in serum Ca over the first 12 h post-dose was -2.93 % (5.70 %) with a nadir of -4.34 % (6.04 %) at 8 h; Ca values returned to baseline by 48 h post-dose. Mean percentage change in iPTH over the first 12 h post-dose was 57.94 % (71.82 %) with a nadir of -35.65 % (55.82 %) at 2 h. There was an inverse relationship between peak serum Ca concentration and body surface area (BSA) (r2=0.41), although no relationship was found between area under the curve and age or BSA. Conclusions: These data support future analysis to determine the therapeutic starting dose of cinacalcet for pediatric patients with sHPT on dialysis.

Original languageEnglish (US)
Pages (from-to)1953-1959
Number of pages7
JournalPediatric Nephrology
Volume27
Issue number10
DOIs
StatePublished - Oct 2012

Keywords

  • CKD-MBD
  • End-stage renal disease
  • Hemodialysis
  • Hyperparathyroidism
  • Pharmacodynamics
  • Pharmacokinetics
  • Secondary

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Nephrology

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    Padhi, D., Langman, C. B., Fathallah-Shaykh, S., Warady, B. A., Salusky, I. B., Lee, E., Wang, C., & Posvar, E. (2012). An open-label study to evaluate a single-dose of cinacalcet in pediatric dialysis subjects. Pediatric Nephrology, 27(10), 1953-1959. https://doi.org/10.1007/s00467-012-2186-9