Post Gastrectomy AnemiaPhase 4NCT03229954
Intravenous Iron Isomaltoside 1000 (Monofer®) Compared With Oral Iron in the Treatment of Postgastrectomy Anemia: An Open-label Randomized Controlled Trial
A Phase 4 study testing iron isomaltoside (Monofer) intravenous infusion and Ferrous sulfate(Feroba-YOU) per oral in people with Post Gastrectomy Anemia, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Post Gastrectomy Anemia
- What is being tested?
- iron isomaltoside (Monofer) intravenous infusion and Ferrous sulfate(Feroba-YOU) per oral
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Aug 2017to Apr 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
Seoul, 120-752
About this study
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.
Read more
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
- Being tested
- iron isomaltoside (Monofer) intravenous infusion, Ferrous sulfate(Feroba-YOU) per oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron isomaltoside (Monofer) intravenous infusionDrug
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.
Ferrous sulfate(Feroba-YOU) per oralDrug
160 mg/day of ferrous sulfate (Feroba-YOU) will be taken per oral for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| IV iron (Monofer) group | Experimental | Iron isomaltoside(Monofer) will be injected intravenously and injection dose will be calculated using Ganzoni formula. Receives: Drug: iron isomaltoside (Monofer) intravenous infusion |
| Oral iron group | Active comparator | Ferrous sulfate(Feroba-YOU) 160mg/day for 12 weeks will be taken per oral. Receives: Drug: Ferrous sulfate(Feroba-YOU) per oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Hemoglobin at 2,4,8 and 12 weeks
Measured: at Baseline and weeks 2, 4, 8, and 12
Secondary outcomes (5)
serum iron
Measured: at Baseline and weeks 2, 4, 8, and 12
serum ferritin
Measured: at Baseline and weeks 2, 4, 8, and 12
serum transferrin
Measured: at Baseline and weeks 2, 4, 8, and 12
transferrin saturation
Measured: at Baseline and weeks 2, 4, 8, and 12
QOL (quality of life) of the patients
Measured: at Baseline and weeks 2, 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start28 Aug 2017
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Gastrectomy AnemiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229954
- Sponsor's protocol ID
- 4-2017-0149
- Status last verified
- Jan 2019
- First submitted
- 23 Jul 2017
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Iron Isomaltoside 1000 (Monofer®) Compared With Oral Iron in the Treatment of Postgastrectomy Anemia: An Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03229954
- Acronym / sponsor ID
- 4-2017-0149
- Conditions
- Post Gastrectomy Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 26 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV iron (Monofer) group | Experimental | Drug: iron isomaltoside (Monofer) intravenous infusionIron isomaltoside(Monofer) will be injected intravenously and injection dose will be calculated using Ganzoni formula. |
| Oral iron group | Active comparator | Drug: Ferrous sulfate(Feroba-YOU) per oralFerrous sulfate(Feroba-YOU) 160mg/day for 12 weeks will be taken per oral. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iron isomaltoside (Monofer) intravenous infusionThe 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 | IV iron (Monofer) group |
| Ferrous sulfate(Feroba-YOU) per oral160 mg/day of ferrous sulfate (Feroba-YOU) will be taken per oral for 12 weeks. | Drug | Oral iron group |
Primary outcome
Change from Baseline Hemoglobin at 2,4,8 and 12 weeks
Time frame: at Baseline and weeks 2, 4, 8, and 12
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing iron isomaltoside (Monofer) intravenous infusion and Ferrous sulfate(Feroba-YOU) per oral in people with Post Gastrectomy Anemia, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Hemoglobin at 2,4,8 and 12 weeks (time frame: at Baseline and weeks 2, 4, 8, and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.