Spots Global Cancer Trial Database for A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
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Trial Identification
Brief Title: A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
Official Title: Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis
Study ID: NCT03969329
Conditions
Interventions
Study Description
Brief Summary: Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric subjects between ≥ 2 to \< 18 years of age, with chronic kidney disease (CKD) on hemodialysis
Detailed Description:
Eligibility
Minimum Age: 2 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Universitair Ziekenhuis Gent, Gent, , Belgium
Fakultni nemocnice v Motole, Praha 5, , Czechia
Hospices Civils de Lyon Hopital Femme Mere Enfant, Bron cedex, , France
Hôpital Armand Trousseau, Paris, , France
Kindernierenzentrum Bonn, Bonn, , Germany
Universitaetsklinikum Hamburg Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitaetsklinikum Heidelberg, Zentrum fuer Kinder und Jugendmedizin, Heidelberg, , Germany
Universitaetsklinikum Koeln, Koeln, , Germany
General Children Hospital Panagioti and Aglaias Kyriakou, Athens, , Greece
Ippokrateio General Hospital of Thessaloniki, Thessaloniki, , Greece
Semmelweis Egyetem, Budapest, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar, Szeged, , Hungary
Azienda Ospedaliera Universitaria Meyer, Firenze, , Italy
Childrens Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos, Vilinus, , Lithuania
Uniwersytecki Szpital Dzieciecy w Krakowie, Krakow, , Poland
Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio, Porto, , Portugal
Hospital Universitario Virgen del Rocio, Sevilla, Andalucía, Spain
Hospital Universitari Vall d Hebron, Barcelona, Cataluña, Spain
Royal Hospital for Sick Children, Glasgow, , United Kingdom
Great Ormond Street Hospital for Children, London, , United Kingdom
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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