EUCTR2017-002452-87-SEActive, not recruitingPhase 1
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
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Pharmacosmos A/S
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 general anaesthesia 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 pre-ferred 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.
Investigators
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