Occurrence of hypophosphataemia in patients with iron deficiency anemia caused by inflammatory bowel disease after treatment with ironisomaltoside or iron carboxymaltose

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

A subject will be eligible for inclusion in the trial if he/she fulfils the
following criteria:
1.Men or women = 18 years
2.Subjects diagnosed with IBD
3.Hb < 13 g/dL
4.Body weight = 50 kg
5.S-ferritin ? 100 ng/mL
6.eGFR = 65 mL/min/1.73 m2
7.S-phosphate > 2.5 mg/dL
8.Oral iron preparations are ineffective or cannot be used or where
there is a clinical need to de-liver iron rapidly
9.Willingness to participate and signing the Informed Consent Form
(ICF)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

A subject will not be eligible for inclusion in this trial if he/she fulfils any of the following criteria:
1.Anaemia predominantly caused by factors other than IDA according
to Investigator's judgment
2.Hb = 10 g/dL and body weight < 70 kg*
3.Hemochromatosis or other iron storage disorders
4.Known hypersensitivity reaction to any component of iron
isomaltoside or ferric carboxymalt-ose
5.Previous serious hypersensitivity reactions to any IV iron compounds
(seriousness criteria are defined in Section 12.2)
6.Treatment with IV iron within the last 30 days prior to screening
7.Treatment with erythropoietin or erythropoietin-stimulation agents,
red blood cell transfusion, radiotherapy, and/or chemotherapy (except immune modulating therapy for
standard IBD treatment) within the last 30 days prior to screening
8.Received an investigational drug within the last 30 days prior to
screening
9.Planned surgical procedure within the trial period
10.Alanine Aminotransferase (ALAT) and/or Aspartate
Aminotransferase (ASAT) > 3 times upper limit of normal (e.g.
decompensated liver cirrhosis or active hepatitis)
11.Surgery under anaesthetic within the last 30 days prior to screening
12.Any non-viral infection within the last 30 days prior to screening
13.Alcohol or drug abuse within the past 6 months
14.Untreated hyperparathyroidism
15.Kidney transplantation
16.Conditions that interfere with the subject's ability to understand the
requirements of the trial and/or presumable non-compliance
17.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
18.Pregnant or nursing women. In order to avoid pregnancy, women of
childbearing potential have to use highly efficient contraception (e.g.
intrauterine devices, hormonal contraceptives (contraceptive pills,
implants, transdermal patches, hormonal vaginal devices or injections
with prolonged release)) during the whole trial period and 7 days after
the last dosing. A sterile sole partner or sexual abstinence is also
considered acceptable provided it reflects the usual and preferred
lifestyle of the participant

*To ensure an iron need of minimum 1500 mg; subjects with a Hb = 10 g/dL must have a body weight = 70 kg. Subjects with a body weight of = 50 kg to < 70 kg are eligible only if Hb is below 10 mg/dL. See Section 10.2 of the protocol for more details and dosing table.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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