Study identification

PURI

https://redirect.ema.europa.eu/resource/50484

EU PAS number

EUPAS23186

Study ID

50484

Official title and acronym

An Observational Study to Evaluate the Potential Association Between ParsabivTM and Gastrointestinal Bleeding (20170561)

DARWIN EU® study

No

Study countries

United States

Study description

The Food and Drug Administration (FDA) required Amgen to conduct an observational study to assess the potential association between ParsabivTM (etelcalcetide) and fatal and non-fatal gastrointestinal bleeding as a post-marketing requirement. This observational study is designed to assess the potential association between ParsabivTM use and the risk of fatal and non-fatal GI bleeding in patients receiving maintenance hemodialysis, using a nested case control study design.

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

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
Study protocol
Initial protocol
English (1.76 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)