Summary:
A Phase III, randomized, open label, comparative safety and efficacy tria of intrfavenous iron isomaltoside (Monofer) and iron sucrose n subjects with iron sucrose in subjects with iron deficiency anemia who are intolerant or unresponsive to oral iron therapy or in whom the hemoglobin measurement in Investigators' opinion were sufficiently low as to require rapid repletion of iron stores to minimize the risk of receiving a blood transfusion.
Inclusions:
- Men or Women 18 and older
- Subjects having IDA caused by different aetiologies such as abnormal uterine bleeding, gastroinstestinal diseases, cancer, bariatric procedures( gastric bypass), and other conditions leading to significant blood loss.
- S-ferritin < 100ng/mL
- Hb≤7g/dL
- Oral intolerance to oral iron/ Hb≤11g/dL
Exclusions:
- Known hypersensitivity raection to any IV iron compounds
- Received an investigational drug within 30days of screening
- Hemochromatosis or other iron storage disorder
- During 30-day period prior to screening or during the trial period, has or will be treated witha red blood cell transfusion, radiotherapy and/or chemotherapy
- Required dialysis for tratment of CKD
Qualified Participants May Receive:
Participants will be compensated for their time and travel.