Study identification

PURI

https://redirect.ema.europa.eu/resource/42909

EU PAS number

EUPAS20720

Study ID

42909

Official title and acronym

Intravenous Iron Postauthorisation Safety Study (PASS): Evaluation of the Risk of Severe Hypersensitivity Reactions

DARWIN EU® study

No

Study countries

Denmark
France
Germany
Netherlands
Sweden

Study description

In September 2013, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (EMA-PRAC) recommended that marketing authorisation holders of intravenous iron compounds conduct a postauthorisation safety study (PASS) to further characterise the safety concerns regarding hypersensitivity reactions. This is a multinational, longitudinal cohort study of new users of intravenous iron compounds conducted in populations covered through electronic health databases and patient registries in Denmark, the Netherlands, France, Germany, and Sweden. The study aims to evaluate the risk of anaphylactic or severe immediate hypersensitivity reactions on the day of or the day after the first intravenous iron use by estimating the incidence proportions of anaphylactic reactions in patients who were first dispensed/administered intravenous iron (new users). Incidence estimates will be calculated for patients overall, by group of intravenous iron product, and by type of intravenous iron product. Risk ratios will be used to compare the risk of anaphylaxis between intravenous iron groups and among the various intravenous iron types at the first exposure. The risk of anaphylactic reactions among new users of an intravenous anaphylaxis marker (penicillin), a compound for which anaphylaxis is a well-recognised side effect, will be estimated to provide context for the risk in users of intravenous iron.

Study status

Finalised
Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner
RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner
Carl von Ossietzky University of Oldenburg Oldenburg, Germany, University Hospital of Cologne - Board of Trustees for Dialysis and Kidney Transplantation (KfH-QiN) Cologne, Germany

Contact details

Lia Gutierrez

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

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

More details on funding

IV Iron Marketing Authorisation Holders (MAH) Consortium, comprising 17 MAHs (see Annex 3 in protocol for full list)
Study protocol
Initial protocol

IV_Iron_PASS_AmendedProtocol_v1.1_04May2017_Redacted

English (2.31 MB - PDF)View document
Updated protocol

IVfePASS_Protocol_V2.1_FINAL_26September2019_Redacted_ok

English (4 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 1 (imposed as condition of marketing authorisation)