Back to resultsA Study of Iron Oligosaccharide in Chronic Kidney Disease Patients
Primary Purpose
Chronic Kidney Disease, Anemia, Iron-Deficiency
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Iron oligosaccharide
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic kidney disease, Aneamia, Iron oligosaccharide, Chronic kidney disease patients
Eligibility 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
Sites / Locations
- Rigshospitalet, Nefrologisk afdeling P
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Iron oligosaccharide
Outcomes
Primary Outcome Measures
Adverse events (AE) (Number and type of AE)
Serious adverse events (SAEs)
Physical examination
Vital signs
Clinical laboratory tests (biochemistry, haematology)
Secondary Outcome Measures
Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00536666
Brief Title
A Study of Iron Oligosaccharide in Chronic Kidney Disease Patients
Official Title
A Non-Comparative Open-Label Study of Iron Oligosaccharide in Chronic Kidney Disease Patients With a Need for Parenteral Iron
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pharmacosmos A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Anemia, Iron-Deficiency
Keywords
Chronic kidney disease, Aneamia, Iron oligosaccharide, Chronic kidney disease patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Iron oligosaccharide
Intervention Type
Drug
Intervention Name(s)
Iron oligosaccharide
Other Intervention Name(s)
MonoFer
Primary Outcome Measure Information:
Title
Adverse events (AE) (Number and type of AE)
Time Frame
Eight weeks after enrollment
Title
Serious adverse events (SAEs)
Time Frame
Eight weeks after enrollment
Title
Physical examination
Time Frame
At screening visit and at end of study
Title
Vital signs
Time Frame
At every visit
Title
Clinical laboratory tests (biochemistry, haematology)
Time Frame
At every visit
Secondary Outcome Measure Information:
Title
Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels
Time Frame
At every visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soeren Ladefoged, MD, DMSc
Organizational Affiliation
Rigshospitalet, Nefrologisk afdeling P
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet, Nefrologisk afdeling P
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
12. IPD Sharing Statement
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A Study of Iron Oligosaccharide in Chronic Kidney Disease Patients
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