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

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

Study timelines

Date when funding contract was signed

Planned: 26/10/2017

Actual: 14/03/2018

Study start date

Planned: 01/05/2018

Actual: 01/05/2018

Data analysis start date

Planned: 01/09/2018

Actual: 01/09/2018

Date of final study report

Planned: 30/06/2019

Actual: 24/06/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen, Inc.

Study protocol

Initial protocol

EUPAS23268-23566

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable