Niedokrwistość: badanie kliniczne fazy III

Kryteria wyłączenia kto nie może wziąć udziału (17)

1. Pregnant or breastfeeding patients
2. Female patients not willing to use a safe method of contraception (PEARL index <1) for the full study (screening - V5).
3. Severe physical inability, e.g., ASA physical status IV or V.
4. Non-iron deficiency anaemia, e.g., known Vitamin B12 or folate deficiency, hemoglobinopathy, or unexplained anaemia.
5. Patients with life-threatening anaemia, defined as Hb < 6.5 g/dL.
6. Patient is expected to require a blood transfusion within the study period or has had a blood transfusion within the 30 days prior screening.
7. Anticipated medical need for erythropoiesis-stimulating agents during the study period (screening - V5).
8. Patients with hemodynamic instability due to any ongoing bleeding. Absence of ongoing bleeding will be confirmed either by decision of two independent physicians or by removal of drainage whichever occurs earlier in routine care.
9. Patient has undergone a surgical procedure during the 30 days prior to screening, and/or is expected to undergo a surgical procedure during the study period (screening - V5).
10. Patients with any contraindication to the investigational products, e.g., 1. known sensitivity to iron or an ingredient of the investigational products, 2. significant history of systemic allergic reactions, 3. hemochromatosis, thalassemia or TSAT >50% as indicator of iron overload, 4. acute or chronic intoxication, 5. infection (patient on non-prophylactic antibiotics), 6. chronic liver disease and/or screening ALT or AST above three times the upper limit of the normal range. 7. chronic kidney disease, defined as GFR <30 mL/min.
11. Primary hematologic disease.
12. Drug or alcohol abuse according to WHO definition.
13. Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
14. Current or previous participation in another clinical trial during the last 90 days before screening.
15. Exclusion criteria according to SmPC of Ferric Carboxymaltose.
16. The following concomitant treatments prescribed by a physician for non-iron deficiency anaemia (e.g., known vitamin B12 or folate deficiency), hemoglobinopathy, or unexplained anaemia are not allowed during the study and 24 weeks before screening: Erythropoiesis-stimulating agents, vitamin B12, Folic acid or other I.V. or oral iron products.
17. Estimated life expectancy of <6 months or, for cancer patients, an Eastern Cooperative Oncology Group performance status >1