A Study of Iron Oligosaccharide in CHF Patients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 27, 2007

Last Updated Date

October 7, 2008

Start Date ^†

June 2007

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00537186 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Single Group Assignment

Condition ^†

Heart Failure, Congestive

Intervention ^†

Drug: Iron oligosaccharide

Study Arms / Comparison Groups

Other: Iron oligosaccharide

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Denmark

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00537186

Responsible Party

Secondary IDs ^††

EudraCT No.: 2007-000764-25

Study Sponsor ^†

Pharmacosmos A/S

Collaborators ^††

Investigators ^†

Principal Investigator:

Per Hildebrandt, MD

Roskilde University Hospital, Medicinsk afdeling

Information Provided By

Pharmacosmos A/S

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.