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
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
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
• 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 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• 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
Young Woo Kim, PhD
National Cancer Center, Rep. of Korea
Korea: Food and Drug Administration