A Study of Iron Oligosaccharide in Chronic Kidney Disease Patients

Chronic Kidney Disease Clinical Trial

Official title:

A Non-Comparative Open-Label Study of Iron Oligosaccharide in Chronic Kidney Disease Patients With a Need for Parenteral Iron

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00536666
• Other study ID #: P-CKD-01
• Secondary ID: EudraCT No.: 200
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2007
• Last updated: October 7, 2008
• Start date: May 2007
• Est. completion date: August 2008

Study information

• Verified date: October 2008
• Source: Pharmacosmos A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics CommitteeSweden: Medical Products AgencySweden: Regional Ethical Review BoardUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety profile of iron oligosaccharide in patients with chronic kidney disease with a need for parenteral iron.

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 such safety reassurance with the use of iron oligosaccharide given either as repeated IV boluses or as total dose infusion for correction/maintenance therapy of anaemia in patients with chronic kidney disease with a need for parenteral iron due to either absolute or functional iron deficiency anaemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Chronic kidney disease patients in pre-dialysis or undergoing dialysis not currently treated with parenteral iron may be included if they meet the following criteria:

• = 18 years of age at screening

• Hb < 110 g/L (6.8 mmol/L)

• Serum ferritin < 800 µgram/L

• Life expectancy beyond 12 months

• Willingness to participate after written informed consent

Chronic kidney disease patients in pre-dialysis or undergoing dialysis willing to switch their current parenteral iron maintenance therapy to iron oligosaccharide may be included if they meet the following criteria:

• = 18 years of age at screening

• Hb = 130 g/L

• Serum ferritin > 200 µgram/L but < 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 three months prior to screening

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Iron oligosaccharide

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Nefrologisk afdeling P	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacosmos A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AE) (Number and type of AE)		Eight weeks after enrollment	Yes
Primary	Serious adverse events (SAEs)		Eight weeks after enrollment	Yes
Primary	Physical examination		At screening visit and at end of study	Yes
Primary	Vital signs		At every visit	Yes
Primary	Clinical laboratory tests (biochemistry, haematology)		At every visit	Yes
Secondary	Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels		At every visit	No