A randomized, open-label, comparative trial comparing the incidence of hypophosphatemia in relation to treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency anemia.
Subject Population
Subjects, who fulfil the following eligibility criteria, will be included.
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 having IDA caused by different aetiologies* such as ab-normal uterine bleeding, gastrointestinal diseases, cancer, bariatric procedures (gastric bypass operations), and other conditions leading to significant blood loss
2. Hb ≤ 11 g/dL
3. Body weight > 50 kg
4. S-ferritin 100 ng/mL
5. Estimated Glomerular Filtration Rate (eGFR) ≥ 65 mL/min/1.73 m2
6. S-phosphate > 2.5 mg/dL
7. Documented history of intolerance or unresponsiveness to oral iron therapy** for at least one month*** prior to trial enrolment
8. Willingness to participate and signing the Informed Consent Form (ICF)
*The aetiology for IDA should be documented in the medical history and verified in the source document.
**The intolerance and non-response to oral iron treatment should be documented with sign and symptoms in the medical history and verified in the source document.
***There should be a documentation of intolerance or unresponsiveness to at least one month of ordinated oral iron therapy per investigator’s judgment within the last 9 months and they would not be candidates for oral iron again.
Exclusion criteria:
A subject will not be eligible for inclusion in this trial if he/she fulfils any of the following criteria:
1. Acute bleeding > 500 mL within 72 hours
2. Anaemia predominantly caused by factors other than IDA according to Investigator's judgment
3. Hemochromatosis or other iron storage disorders
4. Known hypersensitivity reaction to any component of iron isomaltoside or ferric car-boxymaltose
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 within the last 30 days prior to screen-ing
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. Vitamin D deficiency
15. Untreated hyperparathyroidism
16. Kidney transplantation
17. Active malignant disease, disease-free for less than 5 years
18. History of a psychological illness or seizures
19. Conditions that interfere with the subject's ability to understand the requirements of the trial and/or presumable non-compliance
20. 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
21. Pregnant or nursing women. In order to avoid pregnancy, women of childbearing po-tential have to use adequate contraception (e.g. intrauterine devices, hormonal contra-ceptives, or double barrier method) during the whole trial period and 7 days after the last dosing