A Study of Iron Oligosaccharide in CHF Patients
The purpose of this study is to determine the safety profile of iron oligosaccharide in patients with congestive heart failure with a need for parenteral iron.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Non-Comparative Open-Label Study of Iron Oligosaccharide in CHF Patients With Iron Deficiency (Either Absolute or Functional) Anaemia and a Need for Parenteral Iron|
- Adverse events (AE) (Number and type of AE) [ Time Frame: Eight weeks after enrollment ] [ Designated as safety issue: Yes ]
- Serious adverse events (SAEs) [ Time Frame: Eight weeks after enrollment ] [ Designated as safety issue: Yes ]
- Physical examination [ Time Frame: At screening visit and at end of study ] [ Designated as safety issue: Yes ]
- Vital signs [ Time Frame: At every visit ] [ Designated as safety issue: Yes ]
- Clinical laboratory tests (biochemistry, haematology) [ Time Frame: At every visit ] [ Designated as safety issue: Yes ]
- Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels [ Time Frame: At every visit ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Iron dextrans have been marketed for more than 50 years and the compiled preclinical and clinical experience with iron dextrans in general is well established. Pharmacosmos A/S already markets the iron dextran CosmoFer® worldwide, except in the US where the product is named INFeD®. A new iron oligosaccharide has been manufactured by Pharmacosmos A/S and it is a further development of CosmoFer® where ferric hydroxide has been combined with low molecular weight oligosaccharides in a relatively strong complex. This iron carbohydrate complex builds on the well established efficacy and safety profile of existing iron dextran but with a significantly reduced anaphylactic potential.
In order to ensure that iron oligosaccharide will not lead to unexpected adverse events the existing clinical information on iron dextrans in general needs to be supplied with clinical safety data from a limited number of relevant patients exposed to iron oligosaccharide in open label non-comparator studies.
The primary objective of the present study is to obtain safety reassurance with the use of iron oligosaccharide given either as repeated IV boluses or as total dose infusion for the correction of anaemia in patients with congestive heart failure in order to ensure that iron oligosaccharide will not lead to unexpected adverse events in these patients.
|Roskilde University Hospital, Medicinsk afdeling|
|Roskilde, Denmark, DK-4000|
|Principal Investigator:||Per Hildebrandt, MD||Roskilde University Hospital, Medicinsk afdeling|