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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725789
• Other study ID #: NCCCTS-12-644
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2012
• Last updated: December 15, 2016
• Start date: November 2012
• Est. completion date: April 2016

Study information

• Verified date: December 2016
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Anemia

Intervention

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)
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook national university hospital	Dae Gu
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Chollanam Do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Yonsei University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	No
Secondary	• 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	No
Secondary	• Percentage of patients requiring alternative anaemia management therapy	• Percentage of patients requiring alternative anaemia management therapy	12 weeks post baseline	No
Secondary	• 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	No
Secondary	• 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	No
Secondary	• adverse events: type, nature, incidence and outcome	• adverse events: type, nature, incidence and outcome	up to 3 weeks post baseline	Yes