Post Gastrectomy Anemia Clinical Trial
Official title:
Intravenous Iron Isomaltoside 1000 (Monofer®) Compared With Oral Iron in the Treatment of Postgastrectomy Anemia: An Open-label Randomized Controlled Trial
| Verified date | January 2019 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Enrolling by invitation |
| Enrollment | 358 |
| Est. completion date | April 2019 |
| Est. primary completion date | April 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Department of Surgery, Yonsei University College of Medicine, Seoul, Korea | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline Hemoglobin at 2,4,8 and 12 weeks | at Baseline and weeks 2, 4, 8, and 12 | ||
| Secondary | serum iron | at Baseline and weeks 2, 4, 8, and 12 | ||
| Secondary | serum ferritin | at Baseline and weeks 2, 4, 8, and 12 | ||
| Secondary | serum transferrin | at Baseline and weeks 2, 4, 8, and 12 | ||
| Secondary | transferrin saturation | at Baseline and weeks 2, 4, 8, and 12 | ||
| Secondary | QOL (quality of life) of the patients | at Baseline and weeks 2, 4, 8, and 12 |