Patients with anaemia and who have a need for parenteral iron due to either absolute or functional iron deficiency anaemia will be included. Patients may receive concomitant Erythropoeisis Stimulating Agents treatment according to hospital standards but this is not a requirement for participation. Patients previous treated with parenteral iron therapy but still needing further Iron who fullfils the inclusion criteria may be switched from an existing parenteral iron treatment. MedDRA version: 9.
Conditions
Sponsors
Pharmacosmos A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: CHF = 18 years of age at screening Hb =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Non iron deficiency anaemia. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis, haemosiderosis). Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes). Patients with a history of multiple allergies. Decompensated liver cirrhosis and hepatitis (ALAT > 3 times normal). Acute or chronic infections (Clinical evaluation, possibly supported by CRP and WBC). Rheumatoid arthritis with symptoms or signs of active inflammation. Pregnancy and nursing. To avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception. Active bleeding. Planned elective surgery during the study where significant blood loss is expected. Participation in any other clinical trial where the study drug has not passed five half-lives prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 (TDI) for the correction of anaemia in patients with CHF in order to ensure that Iron oligosaccharide will not lead to unexpected adverse events in CHF patients. ;Secondary Objective: To obtain PK data (urine and serum iron - free and bound) in patients with iron deficiency (either absolute or functional) anaemia treated with Iron oligosaccharide. To compare Hb, Hct, TSAT, serum Iron and Ferritin levels 1, 2, 4 and 8 weeks after treatment start to baseline levels. To compare QoL at baseline and 4 and 8 weeks after baseline. ;Primary end point(s): The safety endpoints for this study are: • Adverse events (AE) • Serious adverse events (SAEs) • Physical examination • Vital signs (including ECG) • Clinical Laboratory Tests (Clinical Chemistry, Haematology (additional to efficacy parameters e.g. White blood cells, platelets etc)) | — |
Countries
Sweden
Outcome results
None listed