A Study of Iron Oligosaccharide in Chronic Kidney Disease Patients
|Chronic Kidney Disease Anemia, Iron-Deficiency||Drug: Iron oligosaccharide||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Non-Comparative Open-Label Study of Iron Oligosaccharide in Chronic Kidney Disease Patients With a Need for Parenteral Iron|
- Adverse events (AE) (Number and type of AE) [ Time Frame: Eight weeks after enrollment ]
- Serious adverse events (SAEs) [ Time Frame: Eight weeks after enrollment ]
- Physical examination [ Time Frame: At screening visit and at end of study ]
- Vital signs [ Time Frame: At every visit ]
- Clinical laboratory tests (biochemistry, haematology) [ Time Frame: At every visit ]
- Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels [ Time Frame: At every visit ]
|Study Start Date:||May 2007|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 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 such safety reassurance with the use of iron oligosaccharide given either as repeated IV boluses or as total dose infusion for correction/maintenance therapy of anaemia in patients with chronic kidney disease with a need for parenteral iron due to either absolute or functional iron deficiency anaemia.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00536666
|Rigshospitalet, Nefrologisk afdeling P|
|Copenhagen, Denmark, DK-2100|
|Principal Investigator:||Soeren Ladefoged, MD, DMSc||Rigshospitalet, Nefrologisk afdeling P|