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

NCT01725789 | Completed Phase 3 DMC

• 1 other identifier: NCCCTS-12-644
• Study Type: interventional
• Target: 454
• Locations: 1 country
• Sites: 6

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.

Conditions

Anemia

Keywords

Acute isovolemic anemia after gastrectomy for gastric cancer

Outcome Measures

Primary Outcomes (1)

• • 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

Secondary Outcomes (5)

• • Percentage of patients with Hb ≥10, 11 and 12 g/dL

  3weeks , 12 weeks post baseline

• • Percentage of patients requiring alternative anaemia management therapy

  12 weeks post baseline

• • Self-reported patient assessment of EORTC QLQ C-30 and Sto-22

  3weeks, 12weeks post baseline

• • Evolution of Hb, ferritin and TSAT

  12 weeks post baseline

• • adverse events: type, nature, incidence and outcome

  up to 3 weeks post baseline

Study Arms (2)

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.

Drug: Ferinject®

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.

Drug: normal saline

Interventions

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)

Also known as: Ferric carboxymaltose

Ferinject® Group

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.

Placebo Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 20 years old
• g/dl ≤ Hb \< 10g/dl at 5 - 7 days after gastrectomy for gastric cancer
• signed written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (6)

Chonnam National University Hwasun Hospital

Hwasun, Chollanam Do, 519-763, South Korea

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 411-764, South Korea

Location

Kyungpook national university hospital

Daegu, 700-721, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Yonsei University

Seoul, South Korea

Location

Related Publications (2)

• 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.

  PMID: 28535237 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.

  PMID: 24708660 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

ferric carboxymaltose; Saline Solution

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Young Woo Kim, PhD

  National Cancer Center, Rep. of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Gastric Cancer Research

Study Record Dates

• First Submitted: November 3, 2012
• First Posted: November 14, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: December 16, 2016

Record last verified: 2016-12

Locations

KR (6)