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
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Anemia, Iron-Deficiency
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 Chronic Kidney Disease Patients With 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: 182
Study Start Date: May 2007
Study Completion Date: August 2008
Primary Completion Date: August 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00536666

Locations
Denmark
Rigshospitalet, Nefrologisk afdeling P
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Pharmacosmos A/S
Investigators
Principal Investigator: Soeren Ladefoged, MD, DMSc Rigshospitalet, Nefrologisk afdeling P
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00536666     History of Changes
Other Study ID Numbers: P-CKD-01, EudraCT No.: 2007-000765-37
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
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Pharmacosmos A/S:
Chronic kidney disease
Aneamia
Iron oligosaccharide
Chronic kidney disease patients

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Anemia, Iron-Deficiency
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Renal Insufficiency
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014