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An open-label study to evaluate a single-dose of cinacalcet in pediatric dialysis subjects.
Pediatr Nephrol. 2012 Oct; 27(10):1953-9.PN

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) (r (2) = 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.

Authors+Show Affiliations

Early Development, Amgen Inc., One Amgen Center Dr., M/S 38-3-A, Thousand Oaks, CA 91320, USA. dpadhi@amgen.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

22639045

Citation

Padhi, Desmond, et al. "An Open-label Study to Evaluate a Single-dose of Cinacalcet in Pediatric Dialysis Subjects." Pediatric Nephrology (Berlin, Germany), vol. 27, no. 10, 2012, pp. 1953-9.
Padhi D, Langman CB, Fathallah-Shaykh S, et al. An open-label study to evaluate a single-dose of cinacalcet in pediatric dialysis subjects. Pediatr Nephrol. 2012;27(10):1953-9.
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 (Berlin, Germany), 27(10), 1953-9. https://doi.org/10.1007/s00467-012-2186-9
Padhi D, et al. An Open-label Study to Evaluate a Single-dose of Cinacalcet in Pediatric Dialysis Subjects. Pediatr Nephrol. 2012;27(10):1953-9. PubMed PMID: 22639045.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An open-label study to evaluate a single-dose of cinacalcet in pediatric dialysis subjects. AU - Padhi,Desmond, AU - Langman,Craig B, AU - Fathallah-Shaykh,Sahar, AU - Warady,Bradley A, AU - Salusky,Isidro B, AU - Lee,Edward, AU - Wang,Christine, AU - Posvar,Edward, Y1 - 2012/05/26/ PY - 2011/07/20/received PY - 2012/03/30/accepted PY - 2012/03/29/revised PY - 2012/5/29/entrez PY - 2012/5/29/pubmed PY - 2013/1/25/medline SP - 1953 EP - 9 JF - Pediatric nephrology (Berlin, Germany) JO - Pediatr Nephrol VL - 27 IS - 10 N2 - 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) (r (2) = 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. SN - 1432-198X UR - https://wwww.unboundmedicine.com/medline/citation/22639045/An_open_label_study_to_evaluate_a_single_dose_of_cinacalcet_in_pediatric_dialysis_subjects_ L2 - https://dx.doi.org/10.1007/s00467-012-2186-9 DB - PRIME DP - Unbound Medicine ER -