Post-authorization safety study with Epoetin theta in patients with chronic kidney disease An observational, non-interventional, multinational, multicentre, uncontrolled, prospective cohort study

Study identification

• EU PAS number:
  EUPAS11237
• Study ID:
  28615
• Official title and acronym:
  Post-authorization safety study with Epoetin theta in patients with chronic kidney disease An observational, non-interventional, multinational, multicentre, uncontrolled, prospective cohort study
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Czechia

  Germany

  Greece
• Study description:
  The study was conducted to evaluate if therapy with Epoetin theta in patients with Chronic Kidney Disease (CKD) increases the risk for cardiovascular morbidity and Pure Red Cell Aplasia (PRCA). The primary objective of the study was to assess the incidence and severity of predefined cardiovascular events including ischaemic stroke in a large population of 1,000 CKD patients treated with Epoetin theta. The secondary objective was to detect and describe any adverse drug reaction including PRCA. This was a multinational, multicentre, observational, non-interventional, uncontrolled, prospective cohort studyconducted in Austria, the Czech Republic, Germany and Greece during April 2012 -January 2014.
• Study status:
  Finalised

Research institutions and networks

Institutions

PHARMALOG

Multiple centres: 55 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:31/05/2011

Actual:09/05/2011

Study start date

Planned:30/04/2012

Actual:19/04/2012

Date of interim report, if expected

Planned:30/10/2012

Actual:30/10/2012

Date of final study report

Planned:30/10/2014

Actual:30/10/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merckle GmbH

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable