A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis

PHASE3RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

December 20, 2019

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions
Secondary Hyperparathyroidism
Interventions
DRUG

Etelcalcetide

Etelcalcetide has been shown to be safe and efficacious in treating adult chronic kidney disease (CKD) patients with secondary hyperparathyroidism (SHPT) by simultaneously controlling intact parathyroid hormone (iPTH), calcium (Ca), and phosphorus and has recently been approved for use in adult patients with secondary hyperparathyroidism (SHPT) treated with hemodialysis in both the United States and Europe

Trial Locations (23)

1083

TERMINATED

Semmelweis Egyetem, Budapest

6720

TERMINATED

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar, Szeged

9000

TERMINATED

Universitair Ziekenhuis Gent, Ghent

11527

RECRUITING

General Children Hospital Panagioti and Aglaias Kyriakou, Athens

20246

RECRUITING

Universitaetsklinikum Hamburg Eppendorf, Hamburg

30625

COMPLETED

Medizinische Hochschule Hannover, Hanover

41013

RECRUITING

Hospital Universitario Virgen del Rocio, Seville

50139

TERMINATED

Azienda Ospedaliera Universitaria Meyer, Florence

50937

RECRUITING

Universitaetsklinikum Koeln, Cologne

53127

COMPLETED

Kindernierenzentrum Bonn, Bonn

54642

RECRUITING

Ippokrateio General Hospital of Thessaloniki, Thessaloniki

69120

RECRUITING

Universitaetsklinikum Heidelberg, Zentrum fuer Kinder und Jugendmedizin, Heidelberg

69677

TERMINATED

Hospices Civils de Lyon Hopital Femme Mere Enfant, Bron

75012

COMPLETED

Hopital Armand Trousseau, Paris

150 06

COMPLETED

Fakultni nemocnice v Motole, Prague

08406

TERMINATED

Childrens Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos, Vilinus

30-663

TERMINATED

Uniwersytecki Szpital Dzieciecy w Krakowie, Krakow

4050-651

RECRUITING

Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio, Porto

08035

RECRUITING

Hospital Universitari Vall d Hebron, Barcelona

G51 4TF

RECRUITING

Royal Hospital for Sick Children, Glasgow

LS1 3EX

RECRUITING

Leeds Teaching Hospitals NHS Trust, Leeds

WC1N 3JH

TERMINATED

Great Ormond Street Hospital for Children, London

SO16 6YD

RECRUITING

University Hospital Southampton NHS Foundation Trust, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT03969329 - A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis | Biotech Hunter | Biotech Hunter