454
Participants
Start Date
November 30, 2012
Primary Completion Date
April 30, 2016
Study Completion Date
April 30, 2016
Ferinject®
"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 saline
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.
Chonnam National University Hwasun Hospital, Hwasun
National Cancer Center, Goyang-si
Kyungpook national university hospital, Daegu
Asan Medical Center, Seoul
Samsung Medical Center, Seoul
Yonsei University, Seoul
National Cancer Center, Korea
OTHER_GOV