Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer® (IRON CLAD)
Primary Purpose
Cancer and Chemotherapy Related Anemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Injectafer
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Cancer and Chemotherapy Related Anemia
Eligibility Criteria
Inclusion Criteria:
- Subjects (male of female) ≥ 18 years of age able to give informed consent to the study.
- Subjects with non-myeloid malignancies
- Receiving chemotherapy as part of their cancer treatment with at least 4 weeks of treatment remaining.
- Screening visit central laboratory hemoglobin (Hgb) ≤11 g/dL, but ≥8 g/dL.
- Ferritin between 100 and 800 ng/mL and transferrin saturation (TSAT) =<35%
- Subjects must have Eastern Coopertative Oncology Group (ECOG) performance status of 0-2.
- Life expectancy of at least 6 months.
- Demonstrate the ability to understand the requirements of the study, willingness to abide by study restrictions and to return for the required assessments.
Exclusion Criteria:
- Previous participation in a ferric carboxymaltose clinical trial.
- Known hypersensitivity reaction to any component of ferric carboxymaltose.
- Subjects with overt bleeding
- Any anemia treatment within 4 weeks before inclusion (oral iron, IV iron, transfusion, or erythropoiesis-stimulating agents).
- Subjects on erythropoiesis-stimulating agents.
- Requiring dialysis for the treatment of chronic kidney disease.
- Any non-viral infection.
- Known positive hepatitis with evidence of active disease.
- Received an investigational drug within 30 days of screening.
- Alcohol or drug abuse within the past 6 months.
- Hemochromatosis or other iron storage disorders.
- Any other laboratory abnormality, medical condition or psychiatric disorders which in the opinion of the Investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
- Pregnant or actively trying to become pregnant (Female subjects who are of childbearing age must have a negative pregnancy test at screening and be practicing an acceptable method of birth control during the study).
Sites / Locations
- Compassionate Care Research Group, Inc.
- Compassionate Care Research Group, Inc.
- Compassionate Care Research Group, Inc.
- University Cancer Institute
- AR Development Solutions
- Lakes Research
- H. Lee Moffitt Cancer Center
- Bond Bond Clinic, P.A.
- Joliet Oncology Hematology Associates
- MId-Illinois Hematology & Oncology Associates, Ltd.
- OSF Saint Anthony Medical Center for Cancer Care
- Horizon Oncology Research, Inc.
- Michiana Hematology Oncology, PC
- Northern Indiana Cancer Research Consortium
- Ashland-Bellefonte Cancer Center
- Rcca Md, Llc
- Antietam Oncology and Hematology Group, P.C.
- North Mississippi and Oncology Associates
- Montefiore Medical Center
- East Chester Cancer Center
- The Brookdale University Hospital and Medical Center
- Richmond University Medical Center
- Waverly Hematology Oncology
- Kinston Medical Specialists
- Gettysburg Cancer Center
- Charleston Hematology/Oncology Associates, P.A.
- Carolina Blood and Cancer Care, PA
- Westchase Clinical Associates
- Bon Secours St. Francis Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Injectafer
Normal Saline
Arm Description
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Outcomes
Primary Outcome Measures
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18
The following participants will be considered to have met the primary endpoint:
Participants with observed Hgb decrease from baseline between 0.5 g/dL to 1.0 g/dL on two consecutive visits between Weeks 3 and 18.
Participants with observed Hgb decrease from baseline ≥1.0 g/dL at one visit.
Participants who have a non-study intervention prior to Week 18.
Participants who discontinue prior to Week 18 for lack of efficacy or adverse events.
Secondary Outcome Measures
Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
Nonstudy Intervention is defined as any of the following:
Initiation of erythropoietin for any reason
Blood transfusion
IV iron
Prescribed use of oral iron
Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention
Summary of number and percentage(%) of participants with Hgb increase ≥ 1 g/dL increase at any time point in the absence of non-study intervention.
Percentage of Participants Who Received Nonstudy Intervention
Intervention is defined as any of the following:
Initiation of erythropoietin for any reason
Blood transfusion
IV iron
Prescribed use of oral iron
Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention
Intervention is defined as any of the following:
Initiation of erythropoietin for any reason
Blood transfusion
IV iron
Prescribed use of oral iron
Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention
Participants who discontinued or completed the study, or received a non-study intervention before having an increased in Hgb ≥ 1 g/dL will be censored at last study visit or time of receiving non-study intervention, respectively
Percentage of Participants Requiring a Blood Transfusion
Summary of the number (percentage) of participants requiring a blood transfusion at any time during the trial.
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively.
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively.
Correlation of Change in Hemoglobin With Baseline Hepcidin Level
For participants who receive non-study intervention or early withdraw from the study, the time of intervention or early withdrawal will be considered as end of study, respectively.
Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18
Summary of the actual value and change from baseline in total score of Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue Scale). Ranges from 0-52 and higher scores mean better Quality of Life (QOL). Data collected after receiving non-study intervention will not be included in the summary.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02453334
Brief Title
Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
Acronym
IRON CLAD
Official Title
IRON CLAD: Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Multi-center, Randomized, Double-blinded, Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose Injection) in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 23, 2015 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Regent, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study.
Detailed Description
This is a Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study. Subjects who meet all inclusion criteria and no exclusion criteria, will be randomized into the trial (Group A or B).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer and Chemotherapy Related Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
244 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Injectafer
Arm Type
Experimental
Arm Description
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Intervention Type
Drug
Intervention Name(s)
Injectafer
Other Intervention Name(s)
ferric carboxymaltose injection
Intervention Type
Other
Intervention Name(s)
Normal Saline
Primary Outcome Measure Information:
Title
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18
Description
The following participants will be considered to have met the primary endpoint:
Participants with observed Hgb decrease from baseline between 0.5 g/dL to 1.0 g/dL on two consecutive visits between Weeks 3 and 18.
Participants with observed Hgb decrease from baseline ≥1.0 g/dL at one visit.
Participants who have a non-study intervention prior to Week 18.
Participants who discontinue prior to Week 18 for lack of efficacy or adverse events.
Time Frame
Week 3 to Week 18
Secondary Outcome Measure Information:
Title
Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
Description
Nonstudy Intervention is defined as any of the following:
Initiation of erythropoietin for any reason
Blood transfusion
IV iron
Prescribed use of oral iron
Time Frame
Baseline to Week 18
Title
Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention
Description
Summary of number and percentage(%) of participants with Hgb increase ≥ 1 g/dL increase at any time point in the absence of non-study intervention.
Time Frame
Baseline to Week 18
Title
Percentage of Participants Who Received Nonstudy Intervention
Description
Intervention is defined as any of the following:
Initiation of erythropoietin for any reason
Blood transfusion
IV iron
Prescribed use of oral iron
Time Frame
Baseline to week 18
Title
Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention
Description
Intervention is defined as any of the following:
Initiation of erythropoietin for any reason
Blood transfusion
IV iron
Prescribed use of oral iron
Time Frame
Baseline to week 18
Title
Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention
Description
Participants who discontinued or completed the study, or received a non-study intervention before having an increased in Hgb ≥ 1 g/dL will be censored at last study visit or time of receiving non-study intervention, respectively
Time Frame
Baseline to Week 18
Title
Percentage of Participants Requiring a Blood Transfusion
Description
Summary of the number (percentage) of participants requiring a blood transfusion at any time during the trial.
Time Frame
Baseline to week 18
Title
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Description
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time Frame
Baseline to Day 7
Title
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Description
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time Frame
Baseline to Week 2
Title
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Description
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time Frame
Baseline to Week 3
Title
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Description
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time Frame
Baseline to Week 6
Title
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Description
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time Frame
Baseline to Week 9
Title
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
Description
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time Frame
Baseline to Week 12
Title
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
Description
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time Frame
Baseline to Week 15
Title
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Description
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time Frame
Baseline to Week 18
Title
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
Description
Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively.
Time Frame
Baseline to Week 18
Title
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
Description
Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively.
Time Frame
From Baseline to Week 18
Title
Correlation of Change in Hemoglobin With Baseline Hepcidin Level
Description
For participants who receive non-study intervention or early withdraw from the study, the time of intervention or early withdrawal will be considered as end of study, respectively.
Time Frame
Baseline to Week 18.
Title
Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18
Description
Summary of the actual value and change from baseline in total score of Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue Scale). Ranges from 0-52 and higher scores mean better Quality of Life (QOL). Data collected after receiving non-study intervention will not be included in the summary.
Time Frame
Baseline to Week 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects (male of female) ≥ 18 years of age able to give informed consent to the study.
Subjects with non-myeloid malignancies
Receiving chemotherapy as part of their cancer treatment with at least 4 weeks of treatment remaining.
Screening visit central laboratory hemoglobin (Hgb) ≤11 g/dL, but ≥8 g/dL.
Ferritin between 100 and 800 ng/mL and transferrin saturation (TSAT) =<35%
Subjects must have Eastern Coopertative Oncology Group (ECOG) performance status of 0-2.
Life expectancy of at least 6 months.
Demonstrate the ability to understand the requirements of the study, willingness to abide by study restrictions and to return for the required assessments.
Exclusion Criteria:
Previous participation in a ferric carboxymaltose clinical trial.
Known hypersensitivity reaction to any component of ferric carboxymaltose.
Subjects with overt bleeding
Any anemia treatment within 4 weeks before inclusion (oral iron, IV iron, transfusion, or erythropoiesis-stimulating agents).
Subjects on erythropoiesis-stimulating agents.
Requiring dialysis for the treatment of chronic kidney disease.
Any non-viral infection.
Known positive hepatitis with evidence of active disease.
Received an investigational drug within 30 days of screening.
Alcohol or drug abuse within the past 6 months.
Hemochromatosis or other iron storage disorders.
Any other laboratory abnormality, medical condition or psychiatric disorders which in the opinion of the Investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
Pregnant or actively trying to become pregnant (Female subjects who are of childbearing age must have a negative pregnancy test at screening and be practicing an acceptable method of birth control during the study).
Facility Information:
Facility Name
Compassionate Care Research Group, Inc.
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
Compassionate Care Research Group, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Compassionate Care Research Group, Inc.
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
University Cancer Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
AR Development Solutions
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Lakes Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Bond Bond Clinic, P.A.
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Joliet Oncology Hematology Associates
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
MId-Illinois Hematology & Oncology Associates, Ltd.
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
OSF Saint Anthony Medical Center for Cancer Care
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61108
Country
United States
Facility Name
Horizon Oncology Research, Inc.
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Michiana Hematology Oncology, PC
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46628
Country
United States
Facility Name
Northern Indiana Cancer Research Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46628
Country
United States
Facility Name
Ashland-Bellefonte Cancer Center
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Facility Name
Rcca Md, Llc
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Antietam Oncology and Hematology Group, P.C.
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
North Mississippi and Oncology Associates
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
East Chester Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10469
Country
United States
Facility Name
The Brookdale University Hospital and Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Facility Name
Richmond University Medical Center
City
Staten Island
State/Province
New York
ZIP/Postal Code
10310
Country
United States
Facility Name
Waverly Hematology Oncology
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Kinston Medical Specialists
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Gettysburg Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Charleston Hematology/Oncology Associates, P.A.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Carolina Blood and Cancer Care, PA
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Westchase Clinical Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77042
Country
United States
Facility Name
Bon Secours St. Francis Medical Center
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
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