A Study of Iron Oligosaccharide in CHF Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure, Congestive
• Intervention / Treatment: Drug: Iron oligosaccharide

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Roskilde, Denmark, DK-4000
    • Roskilde University Hospital, Medicinsk afdeling

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 1; Iron oligosaccharide	Drug: Iron oligosaccharide; Other Names: MonoFer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events (AE) (Number and type of AE)	Eight weeks after enrollment
Serious adverse events (SAEs)	Eight weeks after enrollment
Physical examination	At screening visit and at end of study
Vital signs	At every visit
Clinical laboratory tests (biochemistry, haematology)	At every visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels	At every visit

Collaborators and Investigators

• Sponsor: Pharmacosmos A/S
• Investigators: Principal Investigator: Per Hildebrandt, MD, Roskilde University Hospital, Medicinsk afdeling

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (ACTUAL): July 1, 2008
• Study Completion (ACTUAL): July 1, 2008

Study Registration Dates

• First Submitted: September 27, 2007
• First Submitted That Met QC Criteria: September 27, 2007
• First Posted (ESTIMATE): September 28, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): October 8, 2008
• Last Update Submitted That Met QC Criteria: October 7, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: Anaemia; Congestive heart failure; Iron oligosaccharide
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: P-CHF-01; EudraCT No.: 2007-000764-25