Study identification

PURI

https://redirect.ema.europa.eu/resource/26219

EU PAS number

EUPAS21914

Study ID

26219

Official title and acronym

An Observational Study to Evaluate the Potential Association Between Cinacalcet and Gastrointestinal Bleeding (20170171)

DARWIN EU® study

No

Study countries

United States

Study description

An observational study to assess the potential association between cinacalcet use and risk of gastrointestinal bleeding in patients receiving maintenance hemodialysis.

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution
Chronic Disease Research Group (CDRG) Minneapolis, MN, USA

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 final study report

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

More details on funding

Amgen Inc.
Study protocol
Initial protocol
English (1.82 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable