Intravenous Iron Isomaltoside 1000 (Monofer®) Compared With Oral Iron in the Treatment of Postgastrectomy Anemia: An Open-label Randomized Controlled Trial

Launched by YONSEI UNIVERSITY · Jul 24, 2017

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients ≥20 years of age
• • Underwent gastrectomy for stage I or II of primary gastric adenocarcinoma
• • Hb ≤11.0 g/dL at least one year after surgery
• • Willingness to participate after signing informed consent
• Exclusion Criteria:
• • Calculated dosage using the Ganzoni formula \>1,500 mg
• • Any medical condition may have caused the patient to be unsuitable for the completion of the study or placed the patient at potential risk from being in the study
• • Underwent chemotherapy or on chemotherapy
• • Drug hypersensitivity to iron isomaltoside
• • Active acute or chronic infections
• • Known intolerance to oral iron treatment
• • History of anemia due to extensive bleeding or causes other than iron deficiency
• • Untreated vitamin B12 or folate deficiency
• • Blood transfusion, Erythropoiesis stimulating agents(ESA), oral iron or intravenous iron treatment within 4 weeks prior to screening
• • History of bone marrow suppression treatment, active Hepatitis B or C, HIV or hematologic disorder other than iron deficiency
• • Iron overload, hematochromatosis or hemosiderosis
• • Pregnancy or nursing
• • Creatinine clearance rate using Cockcroft-Gault formula \<30 mL/min
• • Participation in any other clinical study within one month prior to screening