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Trial record 30 of 36 for:    pharmacosmos

A Study of Iron Oligosaccharide in CHF Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00537186
Recruitment Status : Completed
First Posted : September 28, 2007
Last Update Posted : October 8, 2008
Information provided by:
Pharmacosmos A/S

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.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Drug: Iron oligosaccharide Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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 CHF Patients With Iron Deficiency (Either Absolute or Functional) Anaemia and a Need for Parenteral Iron
Study Start Date : June 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Iron

Arm Intervention/treatment
Iron oligosaccharide
Drug: Iron oligosaccharide
Other Name: MonoFer

Primary Outcome Measures :
  1. Adverse events (AE) (Number and type of AE) [ Time Frame: Eight weeks after enrollment ]
  2. Serious adverse events (SAEs) [ Time Frame: Eight weeks after enrollment ]
  3. Physical examination [ Time Frame: At screening visit and at end of study ]
  4. Vital signs [ Time Frame: At every visit ]
  5. Clinical laboratory tests (biochemistry, haematology) [ Time Frame: At every visit ]

Secondary Outcome Measures :
  1. Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels [ Time Frame: At every visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00537186

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Roskilde University Hospital, Medicinsk afdeling
Roskilde, Denmark, DK-4000
Sponsors and Collaborators
Pharmacosmos A/S
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Principal Investigator: Per Hildebrandt, MD Roskilde University Hospital, Medicinsk afdeling

Layout table for additonal information Identifier: NCT00537186     History of Changes
Other Study ID Numbers: P-CHF-01
EudraCT No.: 2007-000764-25
First Posted: September 28, 2007    Key Record Dates
Last Update Posted: October 8, 2008
Last Verified: October 2008
Keywords provided by Pharmacosmos A/S:
Congestive heart failure
Iron oligosaccharide
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs