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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 : Recruiting
First Posted : July 26, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : October 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

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.




Primary Outcome Measures :
  1. Change from Baseline Hemoglobin at 2,4,8 and 12 weeks [ Time Frame: at Baseline and weeks 2, 4, 8, and 12 ]

Secondary Outcome Measures :
  1. serum iron [ Time Frame: at Baseline and weeks 2, 4, 8, and 12 ]
  2. serum ferritin [ Time Frame: at Baseline and weeks 2, 4, 8, and 12 ]
  3. serum transferrin [ Time Frame: at Baseline and weeks 2, 4, 8, and 12 ]
  4. transferrin saturation [ Time Frame: at Baseline and weeks 2, 4, 8, and 12 ]
  5. QOL (quality of life) of the patients [ Time Frame: at Baseline and weeks 2, 4, 8, and 12 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Woo Jin Hyung, MD +82-2-2228-2100 WJHYUNG@yuhs.ac

Locations
Korea, Republic of
Department of Surgery, Yonsei University College of Medicine, Seoul, Korea Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Woo Jin Hyung, MD    +82-2-2228-2100    WJHYUNG@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03229954     History of Changes
Other Study ID Numbers: 4-2017-0149
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Iron
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics