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

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.

Study Overview

• Status: Unknown
• Conditions: Post Gastrectomy Anemia
• Intervention / Treatment: Drug: iron isomaltoside (Monofer) intravenous infusion; Drug: Ferrous sulfate(Feroba-YOU) per oral

• Study Type: Interventional
• Enrollment (Anticipated): 358
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Department of Surgery, Yonsei University College of Medicine, Seoul, Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline Hemoglobin at 2,4,8 and 12 weeks	at Baseline and weeks 2, 4, 8, and 12

Secondary Outcome Measures

Outcome Measure	Time Frame
serum iron	at Baseline and weeks 2, 4, 8, and 12
serum ferritin	at Baseline and weeks 2, 4, 8, and 12
serum transferrin	at Baseline and weeks 2, 4, 8, and 12
transferrin saturation	at Baseline and weeks 2, 4, 8, and 12
QOL (quality of life) of the patients	at Baseline and weeks 2, 4, 8, and 12

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2017
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: July 23, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 26, 2017

Study Record Updates

• Last Update Posted (Actual): January 22, 2019
• Last Update Submitted That Met QC Criteria: January 17, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Iron isomaltoside 1000
• Other Study ID Numbers: 4-2017-0149

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No