| Outcome Measures: |
Primary: Percent change in intact parathyroid hormone (iPTH) from baseline during the efficacy assessment period (EAP) at weeks 20 to 26, To evaluate the efficacy of etelcalcetide in reducing the intact parathyroid hormone (iPTH) level in children ages equal to or greater than 2 to less than 18 years with secondary hyperparathyroidism (SHPT) receiving maintenance hemodialysis, 20 to 26 weeks | Secondary: Achievement of a greater than 30% reduction from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment period (EAP), To evaluate the efficacy of etelcalcetide, 20 to 26 weeks|Percent change from baseline in corrected total serum calcium (Ca) and serum phosphorus from baseline during the EAP, To characterize change in laboratory markers of chronic kidney disease, 20 to 26 weeks|Proportion of subjects achieving corrected serum calcium (Ca) levels less than 8.0 mg/dL (2.0 mmol/L) at any time during the study, To characterize the safety of etelcalcetide treatment based on laboratory values, During the treatment period|Proportion of subjects with hypocalcemia (corrected serum calcium levels less than 8.4 mg/dL), To characterize the safety of etelcalcetide treatment based on laboratory values, During the treatment period|Etelcalcetide plasma concentrations before and at the end of dialysis after single and multiple doses, Etelcalcetide plasma concentrations before and at the end of dialysis after single and multiple doses, During the treatment period|Etelcalcetide PK parameter of maximum-observed concentration (Cmax), Etelcalcetide plasma concentrations before and at the end of dialysis after single and multiple doses, During the treatment period|Etelcalcetide pharmacokinetic (PK) parameter of plasma trough concentrations (Cmin), To characterize the pharmacokinetic (PK) of etelcalcetide treatment after single and multiple doses, During the treatment period|Subject incidence of all treatment-emergent adverse events, To characterize the safety of etelcalcetide treatment based on adverse events. Nature, frequency, severity, and relationship to treatment of all adverse events, including those of special interest reported during the study, During the treatment period
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| Locations: |
Universitair Ziekenhuis Gent, Gent, 9000, Belgium|Fakultni nemocnice v Motole, Praha 5, 150 06, Czechia|Hospices Civils de Lyon Hopital Femme Mere Enfant, Bron cedex, 69677, France|Hôpital Armand Trousseau, Paris, 75012, France|Kindernierenzentrum Bonn, Bonn, 53127, Germany|Universitaetsklinikum Hamburg Eppendorf, Hamburg, 20246, Germany|Medizinische Hochschule Hannover, Hannover, 30625, Germany|Universitaetsklinikum Heidelberg, Zentrum fuer Kinder und Jugendmedizin, Heidelberg, 69120, Germany|Universitaetsklinikum Koeln, Koeln, 50937, Germany|General Children Hospital Panagioti and Aglaias Kyriakou, Athens, 11527, Greece|Ippokrateio General Hospital of Thessaloniki, Thessaloniki, 54642, Greece|Semmelweis Egyetem, Budapest, 1083, Hungary|Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar, Szeged, 6720, Hungary|Azienda Ospedaliera Universitaria Meyer, Firenze, 50139, Italy|Childrens Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos, Vilinus, 08406, Lithuania|Uniwersytecki Szpital Dzieciecy w Krakowie, Krakow, 30-663, Poland|Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio, Porto, 4050-651, Portugal|Hospital Universitario Virgen del Rocio, Sevilla, Andalucía, 41013, Spain|Hospital Universitari Vall d Hebron, Barcelona, Cataluña, 08035, Spain|Royal Hospital for Sick Children, Glasgow, G51 4TF, United Kingdom|Leeds Teaching Hospitals NHS Trust, Leeds, LS1 3EX, United Kingdom|Great Ormond Street Hospital for Children, London, WC1N 3JH, United Kingdom|University Hospital Southampton NHS Foundation Trust, Southampton, SO16 6YD, United Kingdom
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