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A Study of Iron Oligosaccharide in Chronic Kidney Disease Patients

This study has been completed.
Sponsor:
Information provided by:
Pharmacosmos A/S
ClinicalTrials.gov Identifier:
NCT00536666
First received: September 27, 2007
Last updated: October 7, 2008
Last verified: October 2008

September 27, 2007
October 7, 2008
May 2007
August 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Adverse events (AE) (Number and type of AE) [ Time Frame: Eight weeks after enrollment ]
  • Serious adverse events (SAEs) [ Time Frame: Eight weeks after enrollment ]
  • Physical examination [ Time Frame: At screening visit and at end of study ]
  • Vital signs [ Time Frame: At every visit ]
  • Clinical laboratory tests (biochemistry, haematology) [ Time Frame: At every visit ]
Complete list of historical versions of study NCT00536666 on ClinicalTrials.gov Archive Site
Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels [ Time Frame: At every visit ] [ Designated as safety issue: No ]
Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels [ Time Frame: At every visit ]
Not Provided
Not Provided
 
A Study of Iron Oligosaccharide in Chronic Kidney Disease Patients
A Non-Comparative Open-Label Study of Iron Oligosaccharide in Chronic Kidney Disease Patients With a Need for Parenteral Iron

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Anemia, Iron-Deficiency
Drug: Iron oligosaccharide
Other Name: MonoFer
1
Iron oligosaccharide
Intervention: Drug: Iron oligosaccharide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
182
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00536666
P-CKD-01, EudraCT No.: 2007-000765-37
No
Not Provided
Pharmacosmos A/S
Not Provided
Principal Investigator: Soeren Ladefoged, MD, DMSc Rigshospitalet, Nefrologisk afdeling P
Pharmacosmos A/S
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP