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

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

Chronic Disease Research Group (CDRG) Minneapolis, MN, USA

Study timelines

Date when funding contract was signed

Planned: 22/12/2016

Actual: 22/12/2016

Study start date

Planned: 02/03/2018

Actual: 02/03/2018

Data analysis start date

Planned: 19/03/2018

Actual: 19/03/2018

Date of final study report

Planned: 01/09/2018

Actual: 07/09/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen Inc.

Study protocol

Initial protocol

20170171_Public Redacted Protocol Ver 1.0 2018-02-12 English

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable