Status: Finalised First registered on: 14/07/2015
Last updated on: 21/03/2019
1. Study identification
EU PAS Register NumberEUPAS10254
Official titleThromboembolic Risk in Patients with Chronic Kidney Disease Treated receiving Epoetin zeta or other Erythropoietin Stimulating Agents – the BIPS study
Study title acronym
Study typeObservational study
Brief description of the studyErythropoietin 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.
Was this study requested by a regulator?Yes: Germany
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBIPS GmbH
Department/Research groupClinical Epidemiology
Organisation/affiliationLeibniz Inst. for Prevention Research and Epidem.
Website/Homepagewww.bips.eu
Details of (Primary) lead investigator
Title Dr
Last name Schink
First name Tania
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed28/07/201128/07/2011
Start date of data collection01/01/200701/01/2007
Start date of data analysis
Date of interim report, if expected
Date of final study report31/03/201710/03/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesSTADA Arzneimittel AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Schink
First name Tania
Address line 1Achterstraße 30
Address line 2 
Address line 3 
CityBremen 
Postcode28359 
CountryGermany
Phone number (incl. country code)49-421-21856860 
Alternative phone number 
Fax number (incl. country code) 
Email address schink@leibniz-bips.de
Public Enquiries
Title Dr 
Last name Schink 
First name Tania 
Address line 1Achterstraße 30 
Address line 2 
Address line 3 
CityBremen 
Postcode 
CountryGermany 
Phone number (incl. country code)004942121856865 
Alternative phone number 
Fax number (incl. country code) 
Email address schink@leibniz-bips.de 
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