Study identification

EU PAS number

EUPAS10254

Study ID

29008

Official title and acronym

Thromboembolic Risk in Patients with Chronic Kidney Disease Treated receiving Epoetin zeta or other Erythropoietin Stimulating Agents – the BIPS study

DARWIN EU® study

No

Study countries

Germany

Study description

Erythropoietin belongs to the group of erythropoiesis-stimulating agents (ESAs) that stimulate the production of red blood cells from the bone marrow. Erythropoietin-containing medicines are used to treat anaemia in patients with cancer who are receiving chemotherapy and in patients with chronic kidney disease (CKD). Currently several medicinal products containing erythropoietin are approved in the European Union including biosimilar products. One of those is epoetin zeta which was licensed 2007 and is marketed in Germany as Silapo®. Several studies showed an increased risk for thromboembolic events associated with ESA use, if ESAs differ with respect to their thromboembolic properties is unknown. To examine the risk of thromboembolic events in patients with CKD treated with ESAs, a retrospective cohort study based on data from the German Pharmacoepidemiological Research database will be conducted for the years 2007 to 2011. The study will compare the risk of thromboembolic events such as myocardial infarction, deep vein thrombosis or pulmonary embolism in patients treated with Epoetin zeta as compared with patients receiving epoetin alpha or other ESAs.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Tania Schink

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

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

More details on funding

STADA Arzneimittel AG
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable