Ferinject® Assessment In GastRectomy Patients With Acute Isovolemic Anemia (FAIRY)

Study Overview
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Brief Summary
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This study is designed to evaluate the efficacy of Ferinject® in improving acute isovolemic anemia after gastrectomy for gastric cancer in terms of Quality of life(QOL )and objective measures (Hb and iron parameters). Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.

Detailed Description
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Randomized patient-blind placebo controlled study. Hb level of 10 g/dl will be used as a cut-off value for our study based on the guidelines published by American Society of Clinical Oncology and the American Society of Hematology for the treatment of cancer-related anemia, recommending Hb<10 g/dl as a treatment threshold. Ferinject® to be administered based on Hb and body weight per approved summary of product characteristics (SmPC). 5 - 7 days after gastrectomy for gastric cancer, consented patients with 7g/dl≤Hb<10g/dl will be administered Ferinject® or placebo (normal saline) based on the results of randomization. • Study Group Ferinject®to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight <50Kg . Note, Ferinject® should be administered to a maximum of 20mg iron/kg. Therefore in patients with a body weight <50kg, administration of Ferinject® should be limited to 500mg at baseline . All patients with a serum ferritin value <15ng/mL at week 4 visit that a second dose (of 500mg iron or equivalent placebo) will be given.(Study group: Ferinject®500mg, Control Group:Placebo) • Control Group Placebo will be in the form of normal saline administered over same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus injection) for body weight <50 Kg.

Official Title
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A Randomized Patient -Blind Controlled Phase III Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject®) With Placebo in Patients With Acute Isovolemic Anemia After Gastrectomy

Conditions
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Anemia

Intervention / Treatment
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* Drug: Ferinject®
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 20 years old 7g/dl ≤ Hb < 10g/dl at 5 - 7 days after gastrectomy for gastric cancer signed written informed consent Exclusion Criteria: a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient hypersensitivity to any component of the formulation active severe infection/inflammation History of transfusion, erythropoietin, > 500 mg intravenous iron administration within 4 weeks prior to screening. History of acquired iron overload. Pregnancy or lactation. Decreased renal function (defined as creatinine clearance < 50 mL/min calculated by Cockcroft-Gault) Chronic liver disease or increase of liver enzymes (ALT, AST) > 3 times the upper limit of normal range. Participation in any other interventional study within 1 month prior to screening.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferinject® Group<br>Ferinject®to be administered as IV drip infusion or undiluted bolus injection to consented patients with 7g/dl≤Hb<10g/dl at 5 - 7 days after gastrectomy for gastric cancer. | Drug: Ferinject®<br>* Ferinject®to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight <50Kg . Note, Ferinject® should be administered to a maximum of 20mg iron/kg. Therefore in patients with a body weight <50kg, administration of Ferinject® should be limited to 500mg at baseline . All patients with a serum ferritin value <15ng/mL and Hb<10g/dl at week 3 visit that a second dose (of 500mg iron or equivalent placebo) will be given.(Study group: Ferinject®500mg, Control Group:Placebo)<br>* Other names: Ferric carboxymaltose;|
| Placebo Comparator: Placebo Group<br>Placebo(0.9% Normal Saline) to be administered as IV drip infusion or bolus injection to consented patients with 7g/dl≤Hb<10g/dl at 5 - 7 days after gastrectomy for gastric cancer. | Drug: normal saline<br>* Placebo will be in the form of normal saline administered over same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus injection) for body weight <50 Kg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Number of responders | • Number of responders (Hb increase ≥2 g/dL with respect to the baseline Hb value and/or Hb ≥11g/dL ) by 12 weeks (independent of alternative anaemia management including transfusion or ESA use). Note, if patient requires an ESA or blood transfusion by week 12 will be considered a non-responder. | 12 weeks post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Percentage of patients with Hb ≥10, 11 and 12 g/dL | • Percentage of patients with Hb ≥10, 11 and 12 g/dL at 3 and 12 weeks (independent of alternative anaemia management including transfusion or ESA use) | 3weeks , 12 weeks post baseline | 
| • Percentage of patients requiring alternative anaemia management therapy | • Percentage of patients requiring alternative anaemia management therapy | 12 weeks post baseline | 
| • Self-reported patient assessment of EORTC QLQ C-30 and Sto-22 | • Self-reported patient assessment of EORTC QLQ C-30 and Sto-22 at 3 weeks and 12 weeks | 3weeks, 12weeks post baseline | 
| • Evolution of Hb, ferritin and TSAT | • Evolution of Hb, ferritin and TSAT over the study duration (12weeks) independent of alternative anaemia management including transfusion or ESA use | 12 weeks post baseline | 
| • adverse events: type, nature, incidence and outcome | • adverse events: type, nature, incidence and outcome | up to 3 weeks post baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute isovolemic anemia after gastrectomy for gastric cancer