Clinical trial · Interventional
Ferinject® Assessment In GastRectomy Patients With Acute Isovolemic Anemia (FAIRY)
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
NCT01725789CI-TRIAL-00025190completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ferinject® | Drug | — | UNRESOLVED |
| normal saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ferinject® Group
- description
- Ferinject®to be administered as IV drip infusion or undiluted bolus injection to consented patients with 7g/dl≤Hb\<10g/dl at 5 - 7 days after gastrectomy for gastric cancer.
- interventionNames
- Drug: Ferinject®
- type
- PLACEBO_COMPARATOR
- label
- Placebo Group
- description
- Placebo(0.9% Normal Saline) to be administered as IV drip infusion or bolus injection to consented patients with 7g/dl≤Hb\<10g/dl at 5 - 7 days after gastrectomy for gastric cancer.
- interventionNames
- Drug: normal saline
Primary outcomes (1)
- measure
- • Number of responders
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDKim 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. PMID 28535237
- DERIVEDReim 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. PMID 24708660