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

National Cancer Center, Korea454 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

454

Conditions

Anemia

Interventions

Ferinject®DRUG

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)

normal salineDRUG

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (6)

Chonnam National University Hwasun Hospital

Hwasun, Chollanam Do, South Korea

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Kyungpook national university hospital

Daegu, South Korea

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

• 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.

Time frame: 12 weeks post baseline

Secondary Outcomes

• 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)

Time frame: 3weeks , 12 weeks post baseline

• Percentage of patients requiring alternative anaemia management therapy

Time frame: 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

Time frame: 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

Time frame: 12 weeks post baseline

• adverse events: type, nature, incidence and outcome

Time frame: up to 3 weeks post baseline

Data from ClinicalTrials.gov

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