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

NCT ID: NCT03229954

Last Updated: 2019-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 358 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-28
• Study Completion Date: 2019-04-30

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 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.

Conditions

Post Gastrectomy Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IV iron (Monofer) group

Iron isomaltoside(Monofer) will be injected intravenously and injection dose will be calculated using Ganzoni formula.

Group Type: EXPERIMENTAL

iron isomaltoside (Monofer) intravenous infusion

Intervention Type: DRUG

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.

Oral iron group

Ferrous sulfate(Feroba-YOU) 160mg/day for 12 weeks will be taken per oral.

Group Type: ACTIVE_COMPARATOR

Ferrous sulfate(Feroba-YOU) per oral

Intervention Type: DRUG

160 mg/day of ferrous sulfate (Feroba-YOU) will be taken per oral for 12 weeks.

Interventions

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.

Intervention Type: DRUG

Ferrous sulfate(Feroba-YOU) per oral

160 mg/day of ferrous sulfate (Feroba-YOU) will be taken per oral for 12 weeks.

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Surgery, Yonsei University College of Medicine, Seoul, Korea

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2017-0149

Identifier Type: -

Identifier Source: org_study_id