Clinical trial NCT00537186: A Study of Iron Oligosaccharide in CHF Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure, Congestive
Keywords: Congestive heart failure
Anaemia
Iron oligosaccharide
Lead sponsor: Pharmacosmos A/S
Sponsor class: INDUSTRY
First posted: 2007-09-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Adverse events (AE) (Number and type of AE)
timeFrame: Eight weeks after enrollment
measure: Serious adverse events (SAEs)
timeFrame: Eight weeks after enrollment
measure: Physical examination
timeFrame: At screening visit and at end of study
measure: Vital signs
timeFrame: At every visit
measure: Clinical laboratory tests (biochemistry, haematology)
timeFrame: At every visit
Secondary outcomes:
measure: Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels
timeFrame: At every visit
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Roskilde University Hospital, Medicinsk afdeling
Study officials:
affiliation: Roskilde University Hospital, Medicinsk afdeling
name: Per Hildebrandt, MD
role: PRINCIPAL_INVESTIGATOR
References: