A Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease

Study Overview
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Brief Summary
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Treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency anaemia due to inflammatory bowel disease and comparison of the incidence of hypophosphatemia

Detailed Description
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Existing IV iron complexes differ in relation to the compounds capability to induce unintended hypophosphatemia to a degree defined as medical significant. This trial is designed evaluate the effect of IV iron isomaltoside compared to IV ferric carboxymaltose on phosphate in subjects with IDA due to inflammatory bowel disease .

Official Title
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A Randomized, Double-blinded, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Repeated Treatment Courses of Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease

Conditions
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IBD

Intervention / Treatment
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* Drug: Iron Isomaltoside
* Drug: Ferric Carboxymaltose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria include: Men or women ≥ 18 years Subjects diagnosed with IBD Hb < 13 g/dL Body weight ≥ 50 kg S-ferritin <100 ng/mL eGFR ≥ 65 mL/min/1.73 m2 S-phosphate > 2.5 mg/dL Oral iron preparations are ineffective or cannot be used or where there is a clinical need to de-liver iron rapidly Willingness to participate and signing the Informed Consent Form (ICF) Exclusion Criteria include: Anaemia predominantly caused by factors other than IDA according to Investigator's judgment Hb ≥ 10 g/dL and body weight < 70 kg Hemochromatosis or other iron storage disorders Known hypersensitivity reaction to any component of iron isomaltoside or ferric carboxymaltose Previous serious hypersensitivity reactions to any IV iron compounds Treatment with IV iron within the last 30 days prior to screening Treatment with erythropoietin or erythropoietin-stimulation agents, red blood cell transfusion, radiotherapy, and/or chemotherapy within the last 30 days prior to screening Received an investigational drug within the last 30 days prior to screening Planned surgical procedure within the trial period hepatic enzymes > 3 times upper limit of normal Surgery under general anaesthesia within the last 30 days prior to screening Any non-viral infection within the last 30 days prior to screening Alcohol or drug abuse within the past 6 months Untreated hyperparathyroidism Kidney transplantation Conditions that interfere with the subject's ability to understand the requirements of the trial and/or presumable non-compliance Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements Pregnant or nursing women.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron Isomaltoside<br>Iron Isomaltoside (Monofer) administered IV | Drug: Iron Isomaltoside<br>* administered IV<br>* Other names: Monofer;|
| Active Comparator: Ferric Carboxymaltose<br>Ferric Carboxymaltose (Injectafer) administered IV | Drug: Ferric Carboxymaltose<br>* administered IV<br>* Other names: Ferinject;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypophosphatemia | s-phosphate < 2 mg/dL | any time from baseline to day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypophosphatemia | s-phosphate < 2 mg/dL | any time from baseline to week 10 | 
| Incidence of s-phosphate < 1.0 mg/dL | s-phosphate < 1.0 mg/dL | any time from baseline to day 35 | 
| Time with hypophosphatemia | time with s-phosphate < 2.0 mg/dL | number of days any time from baseline to week 10 |