A Study of Iron Oligosaccharide in Chronic Kidney Disease Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Kidney Disease, Anemia, Iron-Deficiency

Intervention / Treatment
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* Drug: Iron oligosaccharide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Iron oligosaccharide | Drug: Iron oligosaccharide<br> <br> * Other names: MonoFer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AE) (Number and type of AE) |  | Eight weeks after enrollment | 
| Serious adverse events (SAEs) |  | Eight weeks after enrollment | 
| Physical examination |  | At screening visit and at end of study | 
| Vital signs |  | At every visit | 
| Clinical laboratory tests (biochemistry, haematology) |  | At every visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels |  | At every visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic kidney disease, Aneamia, Iron oligosaccharide, Chronic kidney disease patients