- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02453334
Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer® (IRON CLAD)
May 7, 2021 updated by: American Regent, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
244
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
-
Corona, California, United States, 92879
- Compassionate Care Research Group, Inc.
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Fountain Valley, California, United States, 92708
- Compassionate Care Research Group, Inc.
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Riverside, California, United States, 92501
- Compassionate Care Research Group, Inc.
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Florida
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Boynton Beach, Florida, United States, 33426
- University Cancer Institute
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Miami Lakes, Florida, United States, 33014
- Lakes Research
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Miami Lakes, Florida, United States, 33014
- AR Development Solutions
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Tampa, Florida, United States, 33606
- H. Lee Moffitt Cancer Center
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Winter Haven, Florida, United States, 33880
- Bond Bond Clinic, P.A.
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Illinois
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Joliet, Illinois, United States, 60435
- Joliet Oncology Hematology Associates
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Normal, Illinois, United States, 61761
- Mid-Illinois Hematology & Oncology Associates, Ltd.
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Rockford, Illinois, United States, 61108
- OSF Saint Anthony Medical Center for Cancer Care
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Indiana
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Lafayette, Indiana, United States, 47905
- Horizon Oncology Research, Inc.
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South Bend, Indiana, United States, 46628
- Northern Indiana Cancer Research Consortium
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South Bend, Indiana, United States, 46628
- Michiana Hematology Oncology, PC
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Kentucky
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Ashland, Kentucky, United States, 41101
- Ashland-Bellefonte Cancer Center
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Maryland
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Bethesda, Maryland, United States, 20817
- Rcca Md, Llc
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Hagerstown, Maryland, United States, 21740
- Antietam Oncology and Hematology Group, P.C.
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Mississippi
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Tupelo, Mississippi, United States, 38801
- North Mississippi and Oncology Associates
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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Bronx, New York, United States, 10469
- East Chester Cancer Center
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Brooklyn, New York, United States, 11212
- The Brookdale University Hospital and Medical Center
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Staten Island, New York, United States, 10310
- Richmond University Medical Center
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North Carolina
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Cary, North Carolina, United States, 27518
- Waverly Hematology Oncology
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Kinston, North Carolina, United States, 28501
- Kinston Medical Specialists
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Pennsylvania
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Gettysburg, Pennsylvania, United States, 17325
- Gettysburg Cancer Center
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South Carolina
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Charleston, South Carolina, United States, 29414
- Charleston Hematology/Oncology Associates, P.A.
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Rock Hill, South Carolina, United States, 29732
- Carolina Blood and Cancer Care, PA
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Texas
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Houston, Texas, United States, 77042
- Westchase Clinical Associates
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Virginia
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Midlothian, Virginia, United States, 23114
- Bon Secours St. Francis Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Injectafer
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.
|
Other Names:
|
Placebo Comparator: Normal Saline
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18
Time Frame: Week 3 to Week 18
|
The following participants will be considered to have met the primary endpoint:
|
Week 3 to Week 18
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
Time Frame: Baseline to Week 18
|
Nonstudy Intervention is defined as any of the following:
|
Baseline to Week 18
|
Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention
Time Frame: Baseline to Week 18
|
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.
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Baseline to Week 18
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Percentage of Participants Who Received Nonstudy Intervention
Time Frame: Baseline to week 18
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Intervention is defined as any of the following:
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Baseline to week 18
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Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention
Time Frame: Baseline to week 18
|
Intervention is defined as any of the following:
|
Baseline to week 18
|
Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention
Time Frame: Baseline to Week 18
|
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
|
Baseline to Week 18
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Percentage of Participants Requiring a Blood Transfusion
Time Frame: Baseline to week 18
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Summary of the number (percentage) of participants requiring a blood transfusion at any time during the trial.
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Baseline to week 18
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Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Time Frame: Baseline to Day 7
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Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
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Baseline to Day 7
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Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Time Frame: Baseline to Week 2
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Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
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Baseline to Week 2
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Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Time Frame: Baseline to Week 3
|
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
|
Baseline to Week 3
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Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Time Frame: Baseline to Week 6
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Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
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Baseline to Week 6
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Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Time Frame: Baseline to Week 9
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Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
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Baseline to Week 9
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Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
Time Frame: Baseline to Week 12
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Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
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Baseline to Week 12
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Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
Time Frame: Baseline to Week 15
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Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
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Baseline to Week 15
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Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Time Frame: Baseline to Week 18
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Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
|
Baseline to Week 18
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Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
Time Frame: 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.
|
Baseline to Week 18
|
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
Time Frame: 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.
|
From Baseline to Week 18
|
Correlation of Change in Hemoglobin With Baseline Hepcidin Level
Time Frame: Baseline to Week 18.
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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.
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Baseline to Week 18.
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Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18
Time Frame: 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.
|
Baseline to Week 18
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 23, 2015
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
January 4, 2018
Study Registration Dates
First Submitted
May 21, 2015
First Submitted That Met QC Criteria
May 21, 2015
First Posted (Estimate)
May 25, 2015
Study Record Updates
Last Update Posted (Actual)
May 11, 2021
Last Update Submitted That Met QC Criteria
May 7, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1VIT14039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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