An open-label study to evaluate a single-dose of cinacalcet in pediatric dialysis subjectsReport as inadecuate




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Pediatric Nephrology

, Volume 27, Issue 10, pp 1953–1959

First Online: 26 May 2012Received: 20 July 2011Revised: 29 March 2012Accepted: 30 March 2012

Abstract

BackgroundThere is limited knowledge of the effectiveness and safety profile of cinacalcet in pediatric patients with secondary hyperparathyroidism sHPT treated with dialysis.

MethodsThis 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.

ResultsOverall, 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 = 0.41, although no relationship was found between area under the curve and age or BSA.

ConclusionsThese data support future analysis to determine the therapeutic starting dose of cinacalcet for pediatric patients with sHPT on dialysis.

KeywordsHyperparathyroidism CKD–MBD Hemodialysis End-stage renal disease Pharmacokinetics Pharmacodynamics Secondary  Download fulltext PDF



Author: Desmond Padhi - Craig B. Langman - Sahar Fathallah-Shaykh - Bradley A. Warady - Isidro B. Salusky - Edward Lee - Christin

Source: https://link.springer.com/







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