Intravenous Iron Isomaltoside 1000 (Monofer®) Compared With Oral Iron in the Treatment of Postgastrectomy Anemia: An Open-label Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT03229954|
Recruitment Status : Unknown
Verified January 2019 by Yonsei University.
Recruitment status was: Enrolling by invitation
First Posted : July 26, 2017
Last Update Posted : January 22, 2019
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 treatments in postgastrectomy patients.
Taking an oral iron is an option for iron supplementation, but the postgastrectomy patients has poor absorption of iron due to their anatomic change. Accordingly, intravenous iron supplementation has been emerged as another treatment option, but there are only a few studies to evaluate the efficacy of intravenous iron supplementation compared with oral iron in patients underwent gastrectomy.
Therefore, this study aims to evaluate the iron supplementation method as intravenous injection of iron isomaltoside compared with oral iron in the treatment of postgastrectomy anemia.
Gastric cancer patients who underwent curative gastrectomy more than 1 year ago and hemoglobin level lower than 11 g/dL will be included in this trial. After the registration, the patients will be randomly assigned to intravenous iron (n = 179) or oral iron groups (n = 179).
Calculated dose of iron isomaltoside using Ganzoni formula will be injected intravenously in intravenous iron group and 160 mg/day of ferrous sulfate for 12 weeks will be taken in oral iron group. Hemoglobin and iron profiles at baseline and weeks 2, 4, 8, and 12 and quality of life score at baseline and weeks 12 period will be evaluated.
|Condition or disease||Intervention/treatment||Phase|
|Post Gastrectomy Anemia||Drug: iron isomaltoside (Monofer) intravenous infusion Drug: Ferrous sulfate(Feroba-YOU) per oral||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||358 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intravenous Iron Isomaltoside 1000 (Monofer®) Compared With Oral Iron in the Treatment of Postgastrectomy Anemia: An Open-label Randomized Controlled Trial|
|Actual Study Start Date :||August 28, 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: IV iron (Monofer) group
Iron isomaltoside(Monofer) will be injected intravenously and injection dose will be calculated using Ganzoni formula.
Drug: iron isomaltoside (Monofer) intravenous infusion
The investigational drug is a newest formulation of intravenous iron. The drug, iron isomaltoside (Monofer), will be infused one single high dose with infusion time more than 30 minutes (< 1,000 mg) or 60 minutes (≥ 1,000 mg). The dosage is determined using the Ganzoni formula and divided when the calculated dose exceeds 20 mg/kg.
If the calculated dose exceeds 1,500 mg, the patient will be excluded from trial for patient safety.
Active Comparator: Oral iron group
Ferrous sulfate(Feroba-YOU) 160mg/day for 12 weeks will be taken per oral.
Drug: Ferrous sulfate(Feroba-YOU) per oral
160 mg/day of ferrous sulfate (Feroba-YOU) will be taken per oral for 12 weeks.
- Change from Baseline Hemoglobin at 2,4,8 and 12 weeks [ Time Frame: at Baseline and weeks 2, 4, 8, and 12 ]
- serum iron [ Time Frame: at Baseline and weeks 2, 4, 8, and 12 ]
- serum ferritin [ Time Frame: at Baseline and weeks 2, 4, 8, and 12 ]
- serum transferrin [ Time Frame: at Baseline and weeks 2, 4, 8, and 12 ]
- transferrin saturation [ Time Frame: at Baseline and weeks 2, 4, 8, and 12 ]
- QOL (quality of life) of the patients [ Time Frame: at Baseline and weeks 2, 4, 8, and 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229954
|Korea, Republic of|
|Department of Surgery, Yonsei University College of Medicine, Seoul, Korea|
|Seoul, Korea, Republic of, 120-752|