Observational, non-interventional, multicenter study of adverse events in hemodialysis patients receiving ESA (erythropoiesis-stimulating agents) originators or biosimilars (ESAVIEW -View on erythropoiesis-stimulating agents)

Study identification

• EU PAS number:
  EUPAS5711
• Study ID:
  27994
• Official title and acronym:
  Observational, non-interventional, multicenter study of adverse events in hemodialysis patients receiving ESA (erythropoiesis-stimulating agents) originators or biosimilars (ESAVIEW -View on erythropoiesis-stimulating agents)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Background: Erythropoietin is a growth factor that primarily stimulates red cell production and it is produced by the kidneys. When there is a chronic renal failure, the erythropoietin’s production is not sufficient for the growth of red blood cells and these patients develop anemia. ESAs are administered to anaemic patients. Epoetin alfa has been the first representative of ESA. The patient of epoetin alfa was expired in 2004 and in this year EMA approved two biosimilars of epoetina alfa. These drugs are produced by recombinant DNA technology and the major preoccupation is the immunogenicity. For the complexity of the production process it is necessary a pharmacovigilance’s activity. The study estimates the incidence of adverse event (AE) that happen in patients making hemodialysis and taking ESA. Objectives: The main objective is the safety profile of ESAs: originators and biosimilars. The secondary objectives are the effectiveness and the cost-effectiveness of ESA (originators and biosimilars). Methods: It’s an observational study and the prescription drugs in question are part of the normal clinical practice. The originators observed are Eprex®, Neorecormon®, Aranesp® and Mircera®. The biosimilars are Binocrit® and Retacrit®. The study is conducted in these regions: Veneto (center coordinator), Calabria, Liguria, Molise and Sardinia. Each region has one or more monitors. Inclusion criteria are: 1) patients who do the dialysis at least two times a week, 2) patients receiving ESAs, 3) patients older than 18 years. Esclusion criteria are: patients who are not able to read and sign the informed consent. Criteria for the exit during the study are: 1) patients who are transplanted, 2) patients who switch to peritoneal dialysis. Monitors have to register on a electronic Case Report Form: patient data, drug therapy and specific laboratory tests and adverse event. Results: we are working on and results will be published as soon as available.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pharmacology Unit - Veneto Pharmacovigilance Centre (Pharmacol UNIVR), University Hospital Verona

Italy

15 Dialysis centre Veneto Region, 3 Dialysis centre Sardinia Region, 4 Dialysis centre Molise Region, 1 Dialysis centre Liguria Region, 1 Dialysis centre Calabria Region

Study timelines

Date when funding contract was signed

Planned: 01/01/2011

Actual: 01/01/2011

Study start date

Planned: 01/09/2013

Actual: 01/10/2013

Data analysis start date

Planned: 01/01/2015

Actual: 06/10/2017

Date of final study report

Planned: 31/12/2015

Actual: 20/07/2018

Sources of funding

Other

More details on funding

AIFA_ Italian Medines Agency

Regulatory

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