Phase 1, single-dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of etelcalcetide in pediatric patients with secondary hyperparathyroidism receiving hemodialysis.

Winnie SohnIsidro B SaluskyClaus Peter SchmittChristina TaylanJohan Vande WalleJude NgangLucy YanMark KroenkeBradley A Warady

Published in: Pediatric nephrology (Berlin, Germany) (2020)

Single-dose etelcalcetide (0.035 mg/kg) was well tolerated with expected PK and safety profiles. Overall pattern of changes in serum iPTH and serum calcium was similar between cohorts and consistent with expected responses to etelcalcetide.

Keyphrases

chronic kidney disease
peritoneal dialysis
open label
end stage renal disease
randomized controlled trial
childhood cancer