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.

Phase 1

Conditions: 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: 9.1Level: LLTClassification code 10002062Term: Anaemia iron deficiency
MedDRA version: 9.1Level: LLTClassification code 10010684Term: Congestive heart failure

Registration Number: EUCTR2007-000764-25-DK

Lead Sponsor: Pharmacosmos A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

CHF
= 18 years of age at screening
Hb < 115g/L. (or 7.1 mmol/L) in women and
Hb < 120g/L (or 7.4 mmol/L) in men
Serum Ferritin <800 µgram/L.
Life expectancy beyond 12 months.
Willingness to participate after written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.