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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-23

Study Completion Date

2020-05-25

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

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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 .

Conditions

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IBD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

double-blinded

Study Groups

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Iron Isomaltoside

Iron Isomaltoside (Monofer) administered IV

Group Type EXPERIMENTAL

Iron Isomaltoside

Intervention Type DRUG

administered IV

Ferric Carboxymaltose

Ferric Carboxymaltose (Injectafer) administered IV

Group Type ACTIVE_COMPARATOR

Ferric Carboxymaltose

Intervention Type DRUG

administered IV

Interventions

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Iron Isomaltoside

administered IV

Intervention Type DRUG

Ferric Carboxymaltose

administered IV

Intervention Type DRUG

Other Intervention Names

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Monofer Ferinject

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No