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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Cancer Center, Korea
Sponsor:
Information provided by (Responsible Party):
Young-Woo Kim, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01725789
First received: November 3, 2012
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Anemia
Drug: Ferinject®
Drug: normal saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • • Number of responders [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: No ]
    • 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:
  • • Percentage of patients with Hb ≥10, 11 and 12 g/dL [ Time Frame: 3weeks , 12 weeks post baseline ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • Percentage of patients requiring alternative anaemia management therapy

  • • Average time to response [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: No ]
    • 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: 3weeks, 12weeks post baseline ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: Yes ]
    • adverse events: type, nature, incidence and outcome


Estimated Enrollment: 450
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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.

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 19 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725789

Contacts
Contact: Young Woo Kim, MD, PhD 82-31-920-1635 gskim@ncc.re.kr
Contact: Youngsook Kim, BS 82-31-920-2895 trueclear@ncc.re.kr

Locations
Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Hwasun, Chollanam Do, Korea, Republic of, 519-763
Contact: Young Kyu Park, Dr    +82+10-7173-1196    parkyk@jnu.ac.kr   
Principal Investigator: Young Kyu Park, Dr         
National Cancer Center Recruiting
Goyang, Gyeonggi-do, Korea, Republic of, 411-764
Contact: Young-Woo Kim, MD, PHD    +82-31-920-1635    gskim@ncc.re.kr   
Sub-Investigator: Keun Won Ryu, PhD         
Sub-Investigator: Byoung -Ho Nam, PhD         
Principal Investigator: Young-Woo Kim, PhD         
Sub-Investigator: Hong Man Yoon, MD, PhD         
Sub-Investigator: MiJeong Kim, MD, PhD         
Sub-Investigator: Bangwool Um, PhD         
Kyungpook national university hospital Recruiting
Dae Gu, Korea, Republic of, 700-721
Contact: Wansik Yu, Dr    +82+10-4225-5616    wyu@knu.ac.kr   
Principal Investigator: Wansik Yu, Dr         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jeong-Whan YUK, MD, PhD         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jae-Moon Bae, MD, PhD         
Yonsei University Recruiting
Seoul, Korea, Republic of
Contact: Sung-Hoon ROH         
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Young Woo Kim, PhD National Cancer Center, Rep. of Korea
  More Information

No publications provided by National Cancer Center, Korea

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Young-Woo Kim, Head of Department of Gastric Cancer Research, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01725789     History of Changes
Other Study ID Numbers: NCCCTS-12-644
Study First Received: November 3, 2012
Last Updated: September 25, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by National Cancer Center, Korea:
Acute isovolemic anemia after gastrectomy for gastic cancer

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Ferric Compounds
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014