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

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ClinicalTrials.gov Identifier: NCT01725789
Recruitment Status : Completed
First Posted : November 14, 2012
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Young-Woo Kim, National Cancer Center, Korea

November 3, 2012
November 14, 2012
December 16, 2016
November 2012
April 2016   (Final data collection date for primary outcome measure)
• Number of responders [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01725789 on ClinicalTrials.gov Archive Site
  • • Percentage of patients with Hb ≥10, 11 and 12 g/dL [ Time Frame: 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 [ Time Frame: 12 weeks post baseline ]
    • Percentage of patients requiring alternative anaemia management therapy
  • • Self-reported patient assessment of EORTC QLQ C-30 and Sto-22 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: up to 3 weeks post baseline ]
    • adverse events: type, nature, incidence and outcome
  • • Percentage of patients with Hb ≥10, 11 and 12 g/dL [ Time Frame: 4weeks , 12 weeks post baseline ]
    • Percentage of patients with Hb ≥10, 11 and 12 g/dL at 4 and 12 weeks (independent of alternative anaemia management including transfusion or ESA use)
  • • Percentage of patients requiring alternative anaemia management therapy [ Time Frame: 12 weeks post baseline ]
    • Percentage of patients requiring alternative anaemia management therapy
  • • Average time to response [ Time Frame: 12 weeks post baseline ]
    • Average time to response(from Ferinjec® administration to Assessment) (Hb increase ≥2 g/dL with respect to the baseline Hb value and/or Hb ≥10 g/dL) independent of alternative anaemia management including transfusion or ESA use
  • • Self-reported patient assessment of EORTC QLQ C-30 and Sto-22 [ Time Frame: 4weeks, 12weeks post baseline ]
    • Self-reported patient assessment of EORTC QLQ C-30 and Sto-22 at 4 and 12 weeks
  • • Evolution of Hb, ferritin and TSAT [ Time Frame: 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 [ Time Frame: up to 4 weeks post baseline ]
    • adverse events: type, nature, incidence and outcome
Not Provided
Not Provided
 
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

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Anemia
  • 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)

    Other Name: Ferric carboxymaltose
  • 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.
  • Experimental: Ferinject® Group
    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.
    Intervention: Drug: Ferinject®
  • Placebo Comparator: Placebo Group
    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.
    Intervention: Drug: normal saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
454
450
April 2016
April 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01725789
NCCCTS-12-644
Yes
Not Provided
Not Provided
Young-Woo Kim, National Cancer Center, Korea
National Cancer Center, Korea
Not Provided
Principal Investigator: Young Woo Kim, PhD National Cancer Center, Rep. of Korea
National Cancer Center, Korea
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP