A non-intervention trial of the time to relapse of iron deficiency anemia after standard treatment with a new intravenous iron (Monofer®) (Monofer®-NIS-14)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28191
• EU PAS number:
  EUPAS4492
• Study ID:
  28191
• Official title and acronym:
  A non-intervention trial of the time to relapse of iron deficiency anemia after standard treatment with a new intravenous iron (Monofer®) (Monofer®-NIS-14)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Norway

  Sweden
• Study description:
  A prospective Scandinavian multicentre non-intervention trial with systematic monitoring of iron parameters in relation to intravenous iron isomaltoside 1000 (Monofer®) therapy according to local hospital standards.
• Study status:
  Finalised

Research institutions and networks

Institutions

NA

Multiple centres: 16 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 06/08/2013

Study start date

Planned: 13/09/2013

Actual: 19/08/2013

Date of final study report

Planned: 17/06/2016

Actual: 18/07/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pharmacosmos A/S

Regulatory

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