Ferinject® Assessment In GastRectomy Patients With Acute Isovolemic Anemia (FAIRY)
- Conditions
- Anemia
- Interventions
- Drug: Ferinject®Drug: normal saline
- Registration Number
- NCT01725789
- Lead Sponsor
- National Cancer Center, Korea
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 454
- ≥ 20 years old
- 7g/dl ≤ Hb < 10g/dl at 5 - 7 days after gastrectomy for gastric cancer
- signed written informed consent
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ferinject® Group Ferinject® 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. Placebo Group normal saline 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.
- Primary Outcome Measures
Name Time Method • Number of responders 12 weeks post baseline • 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.
- Secondary Outcome Measures
Name Time Method • Percentage of patients with Hb ≥10, 11 and 12 g/dL 3weeks , 12 weeks post baseline • Percentage of patients with Hb ≥10, 11 and 12 g/dL at 3 and 12 weeks (independent of alternative anaemia management including transfusion or ESA use)
• Percentage of patients requiring alternative anaemia management therapy 12 weeks post baseline • Percentage of patients requiring alternative anaemia management therapy
• Self-reported patient assessment of EORTC QLQ C-30 and Sto-22 3weeks, 12weeks post baseline • Self-reported patient assessment of EORTC QLQ C-30 and Sto-22 at 3 weeks and 12 weeks
• Evolution of Hb, ferritin and TSAT 12 weeks post baseline • Evolution of Hb, ferritin and TSAT over the study duration (12weeks) independent of alternative anaemia management including transfusion or ESA use
• adverse events: type, nature, incidence and outcome up to 3 weeks post baseline • adverse events: type, nature, incidence and outcome
Trial Locations
- Locations (6)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Chollanam Do, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Kyungpook national university hospital
🇰🇷Dae Gu, Korea, Republic of
Yonsei University
🇰🇷Seoul, Korea, Republic of
National Cancer Center
🇰🇷Goyang, Gyeonggi-do, Korea, Republic of