Study identification

PURI

https://redirect.ema.europa.eu/resource/38179

EU PAS number

EUPAS24954

Study ID

38179

Official title and acronym

An Observational Registry Study To Evaluate The Use And Safety Of Cinacalcet Among Paediatric Patients With Secondary Hyperparathyroidism (20180204)

DARWIN EU® study

No

Study countries

Austria
Belgium
Czechia
France
Germany
Greece
Italy
Portugal
Spain
United Kingdom

Study description

This is a non-interventional observational registry of paediatric patients receiving maintenance dialysis with sHPT and using cinacalcet. A patient will receive standard of care treatment as determined by the patient’s physician.

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution
- Universitair Ziekenhuis Gent (Ghent University Hospital)
- Universitaetsklinikum Allgemeines Krankenhaus Wien (Vienna General Hospital)
- Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg
- Hopital Universitaire des Enfants Reine Fabiola (Queen Fabiola Children's University Hospital)
- Universite Catholique de Louvain, Cliniques Universitaires Saint Luc
- Clinique Centre Hospitalier Chrétien MontLégia
- Hospices Civils de Lyon
- Hopital Femme Mere Enfant
- Hopital des Enfants Centre
- Hospitalier Regional Universitaire de Montpellier
- Hopital Arnaud de Villeneuve
- Hopital Pellegrin
- Centre Hospitalier Universitaire Archet 2
- Kindernierenzentrum Bonn
- Medizinische Hochschule Hannover
- Charite – Universitaetsmedizin Berlin, Campus Virchow
- General Children Hospital Panagioti and Aglaias Kyriakou
- Ippokrateio General Hospital of Thessaloniki
- IRCCS Istituto Giannina Gaslini
- IRCCS Ospedale Pediatrico Bambino Gesu
- Unidade Local de Saude de Sao Jose, EPE
- Hospital Universitari Vall d Hebron
- Royal Hospital for Children Glasgow
- Southampton Children's Hospital
- Royal Manchester Children's Hospital

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Study protocol
Initial protocol

01.02.06 Public Redacted Protocol Ver 1.0 English.pdf

English (1.03 MB - PDF)View document
Updated protocol

Protocol-Published Amendment cinacalcet hydrochloride 20180204 8.pdf

English (1.12 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)