Clinical trial NCT01725789: Ferinject® Assessment In GastRectomy Patients With Acute Isovolemic Anemia (FAIRY)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: Acute isovolemic anemia after gastrectomy for gastric cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2012-11-14
Enrollment: 454
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: • Number of responders
timeFrame: 12 weeks post baseline
Secondary outcomes:
measure: • Percentage of patients with Hb ≥10, 11 and 12 g/dL
timeFrame: 3weeks , 12 weeks post baseline
measure: • Percentage of patients requiring alternative anaemia management therapy
timeFrame: 12 weeks post baseline
measure: • Self-reported patient assessment of EORTC QLQ C-30 and Sto-22
timeFrame: 3weeks, 12weeks post baseline
measure: • Evolution of Hb, ferritin and TSAT
timeFrame: 12 weeks post baseline
measure: • adverse events: type, nature, incidence and outcome
timeFrame: up to 3 weeks post baseline
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Chollanam Do
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Dae Gu
country: Korea, Republic of
facility: Kyungpook national university hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University
Study officials:
affiliation: National Cancer Center, Rep. of Korea
name: Young Woo Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim YW, Bae JM, Park YK, Yang HK, Yu W, Yook JH, Noh SH, Han M, Ryu KW, Sohn TS, Lee HJ, Kwon OK, Ryu SY, Lee JH, Kim S, Yoon HM, Eom BW, Choi MG, Kim BS, Jeong O, Suh YS, Yoo MW, Lee IS, Jung MR, An JY, Kim HI, Kim Y, Yang H, Nam BH; FAIRY Study Group. Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response Among Patients With Acute Isovolemic Anemia Following Gastrectomy: The FAIRY Randomized Clinical Trial. JAMA. 2017 May 23;317(20):2097-2104. doi: 10.1001/jama.2017.5703.
citation: Reim D, Kim YW, Nam BH, Kim MJ, Yook JH, Park YK, Roh SH, Yu WS, Bae JM. FAIRY: a randomized controlled patient-blind phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose (Ferinject(R)) to placebo in patients with acute isovolemic anemia after gastrectomy - study protocol for a randomized controlled trial. Trials. 2014 Apr 5;15:111. doi: 10.1186/1745-6215-15-111.