Non-interventional study of time to relapse of iron deficiency anaemia after Monofer
Research type
Research Study
Full title
A non-interventional study of the time to relapse of iron deficiency anaemia after standard treatment with the intravenous iron Monofer® (10% Iron Isomaltoside 1000)
IRAS ID
182160
Contact name
Jason Moore
Contact email
Sponsor organisation
Pharmacosmos UK Ltd
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
Intravenous (IV) iron is a well-tolerated and efficacious treatment for various conditions. In some of these conditions (inflammatory bowel disease, anaemia in chronic kidney disease and cancer) IV iron has been shown to be more effective than oral iron, likely due to decreased absorption (caused by the hepatic hormone hepcidin) and poor compliance (due to gastrointestinal side-effects) using oral iron.
The patented iron isomaltoside 1000 (Monofer®) has been developed to overcome the current limitations with regards to safety and convenience of use. The iron is strongly bound to the isomaltoside 1000 molecule thereby minimising the risk of free iron enabling administration of high doses in a short time, often in single visits. With Monofer®, it is possible to administer iron in doses up to 20 mg/kg in 60 minutes or less, depending on the dose. In addition, iron isomaltoside 1000 (Monofer®) consists of 3-5 glucose units which have a very low immunological activity, and therefore does not require any test dose. The possibility to administer Monofer® at high single doses reduces the number of treatment visits needed for full iron correction, which is cost-effective, resource and time-sparing, and a reduced drug exposure frequency decreases the risk of side-effects such as infusion reactions.
The objective is to monitor and quality assure the efficacy, including effects on quality of life, and safety of Monofer® in a broad patient population when Monofer® is used according to the Monofer® label (SPC) in current clinical practice and where standard routines are being followed. The scientific rationale being to fulfil a need for systematic information/auditing on applied practice including both short and long-term experience with the use of IV iron in different hospital settings and in current clinical practice. The outcome will provide an evidence base for optimised treatment procedures in terms of safety and efficacy.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
15/EM/0303
Date of REC Opinion
29 Jun 2015
REC opinion
Favourable Opinion