E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Iron deficiency anemia in subject with inflammatory bowel disease |
Eisenmangelanämie bei Patienten mit chronisch-entzündlicher Darmerkrankung |
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E.1.1.1 | Medical condition in easily understood language |
Iron deficiency anemia in subject with inflammatory bowel disease |
Blutarmut aufgrund von Eisenmangel bei Patienten mit einer chronisch-entzündlichen Darmerkrankung |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10079322 |
E.1.2 | Term | Anaemia of chronic inflammation |
E.1.2 | System Organ Class | 10005329 - Blood and lymphatic system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10005329 |
E.1.2 | Term | Blood and lymphatic system disorders |
E.1.2 | System Organ Class | 10005329 - Blood and lymphatic system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the trial is to compare the incidence of hypophosphatemia in subjects with IDA due to IBD treated with iron isomaltoside or ferric carboxymaltose. |
Die Hauptzielgröße dieser Studie ist es, die Inzidenzen von Hypophosphatämie bei Patienten mit Eisenmangelanämie aufgrund von CED bei Behandlung mit Eisen-Isomaltosid oder Eisenhydroxid-Polymaltose zu vergleichen. |
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E.2.2 | Secondary objectives of the trial |
The secondary efficacy objective of the trial is to compare the effects of iron isomaltoside and ferric carboxymaltose treatment in subjects with IDA due to IBD on haemoglobin (Hb), s-ferritin, and Transferrin Saturation (TSAT). In addition to the primary and secondary objectives, the effect of iron isomaltoside and ferric carboxymaltose will be investigated purely exploratory on the following: (1) Biochemical bone/muscle markers (2) Fatigue symptoms (3) QoL (4) Bone pain (5) Muscle strength (6) Disease activity status |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) |
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E.4 | Principal exclusion criteria |
A subject will not be eligible for inclusion in this trial if he/she fulfils any E.5 END POINT(S): 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the incidence of hypophosphatemia (defined as s-phosphate < 2 mg/dL) at any time from baseline to day 35. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At any time from baseline to day 35.
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E.5.2 | Secondary end point(s) |
The secondary efficacy endpoints are the following: • Change in Hb, s-ferritin, and TSAT from baseline to day 1 and weeks 1, 2, 5, 6, 7, and 10 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
From baseline to day 1 and weeks 1, 2, 5, 6, 7, and 10 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |