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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferinject® Group | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferinject® | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| • Number of responders | • 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. | 12 weeks post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| • Percentage of patients with Hb ≥10, 11 and 12 g/dL | • 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) | 3weeks , 12 weeks post baseline |
| • Percentage of patients requiring alternative anaemia management therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young Woo Kim, PhD | National Cancer Center, Rep. of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hwasun Hospital | Hwasun | Chollanam Do | 519-763 | South Korea | ||
| National Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28535237 | Derived | 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. | |
| 24708660 |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| normal saline | Drug | 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. |
|
• Percentage of patients requiring alternative anaemia management therapy |
| 12 weeks post baseline |
| • Self-reported patient assessment of EORTC QLQ C-30 and Sto-22 | • Self-reported patient assessment of EORTC QLQ C-30 and Sto-22 at 3 weeks and 12 weeks | 3weeks, 12weeks post baseline |
| • Evolution of Hb, ferritin and TSAT | • Evolution of Hb, ferritin and TSAT over the study duration (12weeks) independent of alternative anaemia management including transfusion or ESA use | 12 weeks post baseline |
| • adverse events: type, nature, incidence and outcome | • adverse events: type, nature, incidence and outcome | up to 3 weeks post baseline |
| Goyang-si |
| Gyeonggi-do |
| 411-764 |
| South Korea |
| Kyungpook national university hospital | Daegu | 700-721 | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Yonsei University | Seoul | South Korea |
| Derived |
| 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. |