Study identification

PURI

https://redirect.ema.europa.eu/resource/30274

EU PAS number

EUPAS23268

Study ID

30274

Official title and acronym

Cinacalcet Use and the Risk of Gastrointestinal (GI) Bleeding Among Hemodialysis Patients with Secondary Hyperparathyroidism (SHPT) in DOPPS

DARWIN EU® study

No

Study countries

United States

Study description

The rate of GI bleeding in the 2013 US Medicare hemodialysis population was 23 per 1,000 patien-years (PYs), while the mortality rate from GI bleeding was 0.91 per 1,000 PYs. In placebo-controlled trials, the rate of GI bleeding in hemodialysis patients was similar in the etelcalcetide group (2.0%) and the placebo group (2.1%). We will conduct an observational study to address the possibility of a potential association between calcimimetics and fatal and non-fatal GI bleeding in a population of hemodialysis patients.

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

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 (433.84 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable