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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 : Unknown
Verified January 2019 by Yonsei University.
Recruitment status was:  Enrolling by invitation
First Posted : July 26, 2017
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE July 23, 2017
First Posted Date  ICMJE July 26, 2017
Last Update Posted Date January 22, 2019
Actual Study Start Date  ICMJE August 28, 2017
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
Change from Baseline Hemoglobin at 2,4,8 and 12 weeks [ Time Frame: at Baseline and weeks 2, 4, 8, and 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Iron Isomaltoside 1000 (Monofer®) Compared With Oral Iron in the Treatment of Postgastrectomy Anemia: An Open-label Randomized Controlled Trial
Official Title  ICMJE Intravenous Iron Isomaltoside 1000 (Monofer®) Compared With Oral Iron in the Treatment of Postgastrectomy Anemia: An Open-label Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Post Gastrectomy Anemia
Intervention  ICMJE
  • 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.

  • Drug: Ferrous sulfate(Feroba-YOU) per oral
    160 mg/day of ferrous sulfate (Feroba-YOU) will be taken per oral for 12 weeks.
Study Arms  ICMJE
  • Experimental: IV iron (Monofer) group
    Iron isomaltoside(Monofer) will be injected intravenously and injection dose will be calculated using Ganzoni formula.
    Intervention: Drug: iron isomaltoside (Monofer) intravenous infusion
  • Active Comparator: Oral iron group
    Ferrous sulfate(Feroba-YOU) 160mg/day for 12 weeks will be taken per oral.
    Intervention: Drug: Ferrous sulfate(Feroba-YOU) per oral
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 24, 2017)
358
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03229954
Other Study ID Numbers  ICMJE 4-2017-0149
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP