ArticlePediatric nephrology (Berlin, Germany)2026
The pharmacokinetics of a single intravenous dose of difelikefalin in adolescents aged 12 to 17 years on hemodialysis.
Article in Pediatric nephrology (Berlin, Germany), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundThe aim of this study was to evaluate the pharmacokinetic profile, safety, and tolerability of a single intravenous bolus injection of difelikefalin in adolescents on maintenance hemodialysis.
methodsIn this multicenter, open-label study, adolescents (12 to 17 years old) received a single difelikefalin dose of 0.5 μg/kg dry body weight at the end of the dialysis. Blood samples were collected over 3 days to assess difelikefalin plasma concentrations, and participants were followed up for adverse events (AEs) for 7-10 days. Key pharmacokinetic parameters were maximum plasma concentration (C
resultsEight participants completed the study and seven (3 males and 4 females; aged 12-17 [mean 15.1] years) had evaluable pharmacokinetic data. Mean (standard deviation) C
conclusionAfter a single difelikefalin 0.5 μg/kg dose, the overall exposure in adolescents on hemodialysis was comparable to prior adult data, with no new safety signals identified, supporting further evaluation of the 0.5 μg/kg dose in adolescents with moderate-to-severe chronic kidney disease-associated pruritus.
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