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

PHASE3CompletedINTERVENTIONAL
Enrollment

454

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Anemia
Interventions
DRUG

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)"

DRUG

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.

Trial Locations (6)

519-763

Chonnam National University Hwasun Hospital, Hwasun

411-764

National Cancer Center, Goyang-si

700-721

Kyungpook national university hospital, Daegu

Unknown

Asan Medical Center, Seoul

Samsung Medical Center, Seoul

Yonsei University, Seoul

All Listed Sponsors
lead

National Cancer Center, Korea

OTHER_GOV

NCT01725789 - Ferinject® Assessment In GastRectomy Patients With Acute Isovolemic Anemia (FAIRY) | Biotech Hunter | Biotech Hunter