Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease

Study Overview
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Brief Summary
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The study is a prospective, non-controlled, open-label multi-centre pilot safety study of iron isomaltoside 1000 (Monofer®) administered to subjects with anaemia and Inflammatory Bowel Disease (IBD). Based upon haemoglobin (Hb) level, the subjects are divided into two treatment groups, A and B. Depending on the body weight, subjects in Treatment Group A will receive a total dose of 1,500 mg or 2,000 mg IV iron isomaltoside 1000 as a single infusion, whereas subjects in Treatment Group B will receive a total dose of 2,500 mg or 3,000 mg IV iron isomaltoside 1000 divided into two administrations.

Detailed Description
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Subjects with a diagnosis of IBD (Crohn's disease or ulcerative colitis) and IDA ( Iron Deficiency Anaemia) with or without concomi-tant inflammation will be enrolled to receive a high dose of IV iron isomaltoside 1000.

Official Title
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A Prospective, Non-controlled, Safety Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease (PROMISE)

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Drug: Iron Isomaltoside 1000


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with age ≥ 18 years Subjects diagnosed with IBD either in remission or active Hb < 12 g/dL for women and Hb < 13 g/dL for men Subjects with a CRP above upper limit of normality must have a ferritin below 100 µg/L, whereas subjects with a CRP below or equal to upper limit of normality must have a ferritin below 30 µg/L Willingness to participate after signing informed consent Exclusion Criteria: Patient judged by the physician to be in need of surgery due to Crohn´s disease or ulcerative colitis within the next 2 months Anaemia predominantly caused by factors other than IDA Iron overload or disturbance in utilisation of iron (e.g. haemochromatosis and haemosiderosis) Known hypersensitivity to any excipients of iron isomaltoside 1000 History of multiple allergies Decompensated liver cirrhosis and/or known chronic viral hepatitis (defined as Alanine Aminotransferase (ALAT) > 3 times upper limit of normal) Acute and/or chronic infections Body weight < 50 kg Rheumatoid arthritis with symptoms or signs of active joint inflammation Pregnancy and nursing. In order to avoid pregnancy, women have to be postmenopausal, surgically sterile, or use one of the following contraceptives during the whole study period and 5 days after the study has ended (i.e. 5 times plasma biological half-life of the investigational medicinal product): intrauterine devices and hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release) Blood transfusion within the previous 12 weeks Subjects with a history of asthma, allergic eczema, or other atopic allergy Planned elective surgery during the study Untreated Vitamin B12 or folate deficiency, defined as values below the lower reference range Participation in any other clinical study within 3 months prior to Screening IV iron treatment within 8 weeks prior to Screening Oral iron treatment within 1 week prior to Screening Erythropoiesis Stimulating Agent (ESA) treatment within 8 weeks prior to Screening Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study

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

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A Monofer<br>Depending on the body weight, subjects in Treatment Group A will receive a total dose of 1,500 mg or 2,000 mg IV iron isomaltoside 1000 where 1,500 mg is administered as a single infusion and 2,000 mg is divided into 2 administrations: 1 administration of 1,500 mg at baseline and 1 administration of 500 mg 1 week later. All doses will be diluted in 100 ml normal saline (0.9 % sodium chloride) and administered by infusion over approximately 15 minutes. | Drug: Iron Isomaltoside 1000<br>* 1500-3000mg IV depending on HB level, sex and body weight<br>* Other names: Monofer;|
| Experimental: Group B Monofer<br>Depending on the body weight, Subjects in Treatment Group B will receive a total dose of 2,500 mg or 3,000 mg IV iron isomaltoside 1000 divided into 2 administrations; 1 administration of 1,500 mg and 8 weeks later a second administration of 1,000 mg or 1,500 mg.. All doses will be diluted in 100 ml normal saline (0.9 % sodium chloride) and administered by infusion over approximately 15 minutes. | Drug: Iron Isomaltoside 1000<br>* 1500-3000mg IV depending on HB level, sex and body weight<br>* Other names: Monofer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of the study is to evaluate the safety of a high IV iron dosing regimen of iron isomaltoside 1000 in subjects with IDA secondary to IBD. | type and incidence of adverse drug reactions (ADRs) | up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of a high IV iron dosing regimen of iron isomaltoside 1000 | obtain a target Hb (≥ 13 g/dL in men and ≥ 12g/dL in women) | up to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBD, IDA, Subjects, diagnosis