Status:
UNKNOWN
Intravenous Iron Isomaltoside 1000 (Monofer®) Compared With Oral Iron in the Treatment of Postgastrectomy Anemia: An Open-label Randomized Controlled Trial
Lead Sponsor:
Yonsei University
Conditions:
Post Gastrectomy Anemia
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
Iron deficiency anemia is a common complication in patients who underwent gastrectomy and leads to a deterioration in patient's quality of life. Therefore iron supplementation is one of the important ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2019
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT03229954
Start Date
August 28 2017
End Date
April 1 2019
Last Update
January 22 2019
Active Locations (1)
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1
Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
Seoul, South Korea, 120-752