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

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 institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Innovation Monitoring and Health Technology Assessment, German Institute for Medical Documentation and Information (DIMDI)

Germany

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Bordeaux PharmacoEpi, University of Bordeaux

France

Carl von Ossietzky University of Oldenburg Oldenburg, Germany, University Hospital of Cologne - Board of Trustees for Dialysis and Kidney Transplantation (KfH-QiN) Cologne, Germany

Study timelines

Date when funding contract was signed

Planned: 01/02/2017

Actual: 16/03/2017

Study start date

Planned: 30/03/2018

Actual: 09/03/2018

Date of final study report

Planned: 30/03/2020

Actual: 29/04/2020

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

Updated protocol

IVfePASS_Protocol_V2.1_FINAL_26September2019_Redacted_ok

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)