Ferumoxytol-5005: Hypersensitivity events occurring proximal to administration of intravenous iron

Study identification

• EU PAS number:
  EUPAS15737
• Study ID:
  44009
• Official title and acronym:
  Ferumoxytol-5005: Hypersensitivity events occurring proximal to administration of intravenous iron
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The purpose of this study was to assess incidence of hypersensitivity events and mortality proximal to intravenous (IV) iron use. This was assessed among a 2010 and 2011 US: 1) Dialysis population using CMS end-stage renal disease (ESRD) data, and 2) Non-dialysis chronic kidney disease (CKD) and non-CKD population using Medicare 20% sample data. Incidence of hypersensitivity and mortality rates were reported by IV iron type (InFed, Ferrlecit, Venofer, and Feraheme).
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual:08/04/2014

Study start date

Actual:16/04/2014

Data analysis start date

Actual:30/04/2014

Date of final study report

Actual:17/06/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda Development Centre

Regulatory

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