A Study of Iron Oligosaccharide in CHF Patients

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacosmos A/S
• Treatments: Iron

Criteria

Inclusion Criteria:

• Congestive heart failure

• ≥ 18 years of age at screening

• Haemoglobin < 110 g/L (or 6.8 mmol/L)

• Serum ferritin < 800 µgram/L

• Life expectancy beyond 12 months

• Willingness to participate after written informed consent

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 (alanine aminotransferase > 3 times normal) Acute or chronic infections 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 within 3 months prior to screening