A Study of Iron Oligosaccharide in CHF Patients

This study has been completed.
Sponsor:
Information provided by:
Pharmacosmos A/S
ClinicalTrials.gov Identifier:
NCT00537186
First received: September 27, 2007
Last updated: October 7, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Heart Failure, Congestive
Drug: Iron oligosaccharide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pharmacosmos A/S:

Primary Outcome Measures:
  • Adverse events (AE) (Number and type of AE) [ Time Frame: Eight weeks after enrollment ] [ Designated as safety issue: Yes ]
  • Serious adverse events (SAEs) [ Time Frame: Eight weeks after enrollment ] [ Designated as safety issue: Yes ]
  • Physical examination [ Time Frame: At screening visit and at end of study ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: At every visit ] [ Designated as safety issue: Yes ]
  • Clinical laboratory tests (biochemistry, haematology) [ Time Frame: At every visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels [ Time Frame: At every visit ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Iron oligosaccharide
Drug: Iron oligosaccharide
Other Name: MonoFer

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537186

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

No publications provided

ClinicalTrials.gov Identifier: NCT00537186     History of Changes
Other Study ID Numbers: P-CHF-01, EudraCT No.: 2007-000764-25
Study First Received: September 27, 2007
Last Updated: October 7, 2008
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by Pharmacosmos A/S:
Congestive heart failure
Anaemia
Iron oligosaccharide

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014