Cancer and Chemotherapy Related AnemiaPhase 3IRON CLADNCT02453334
Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
A Phase 3 study testing Injectafer and Normal Saline in people with Cancer and Chemotherapy Related Anemia, run by American Regent, Inc. at 29 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer and Chemotherapy Related Anemia
- What is being tested?
- Injectafer and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 29 sitesUnited States
- Study dates
- 23 May 2015to 4 Jan 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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).
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Ashland-Bellefonte Cancer Center
Ashland, Kentucky, 41101
Rcca Md, Llc
Bethesda, Maryland, 20817
University Cancer Institute
Boynton Beach, Florida, 33426
The Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212
Waverly Hematology Oncology
Cary, North Carolina, 27518
Charleston Hematology/Oncology Associates, P.A.
Charleston, South Carolina, 29414
Compassionate Care Research Group, Inc.
Corona, California, 92879
Compassionate Care Research Group, Inc.
Fountain Valley, California, 92708
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
Antietam Oncology and Hematology Group, P.C.
Hagerstown, Maryland, 21740
Westchase Clinical Associates
Houston, Texas, 77042
Joliet Oncology Hematology Associates
Joliet, Illinois, 60435
Kinston Medical Specialists
Kinston, North Carolina, 28501
Horizon Oncology Research, Inc.
Lafayette, Indiana, 47905
AR Development Solutions
Miami Lakes, Florida, 33014
Lakes Research
Miami Lakes, Florida, 33014
Bon Secours St. Francis Medical Center
Midlothian, Virginia, 23114
MId-Illinois Hematology & Oncology Associates, Ltd.
Normal, Illinois, 61761
Compassionate Care Research Group, Inc.
Riverside, California, 92501
Carolina Blood and Cancer Care, PA
Rock Hill, South Carolina, 29732
OSF Saint Anthony Medical Center for Cancer Care
Rockford, Illinois, 61108
Michiana Hematology Oncology, PC
South Bend, Indiana, 46628
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628
Richmond University Medical Center
Staten Island, New York, 10310
H. Lee Moffitt Cancer Center
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
East Chester Cancer Center
The Bronx, New York, 10469
North Mississippi and Oncology Associates
Tupelo, Mississippi, 38801
Bond Bond Clinic, P.A.
Winter Haven, Florida, 33880
About this study
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
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.
Read the 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).
- Conditions
- Cancer and Chemotherapy Related Anemia
- Being tested
- Injectafer, Normal Saline
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InjectaferDrug
Also called ferric carboxymaltose injection
Normal SalineOther
| Study group | Role | What they receive |
|---|---|---|
| Injectafer | Experimental | 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. Receives: Drug: Injectafer |
| Normal Saline | Placebo comparator | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 3 to Week 18
Secondary outcomes (18)
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
Measured: Baseline to Week 18
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.
Measured: Baseline to Week 18
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
Measured: Baseline to week 18
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
Measured: Baseline to week 18
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
Measured: Baseline to Week 18
Percentage of Participants Requiring a Blood Transfusion
Summary of the number (percentage) of participants requiring a blood transfusion at any time during the trial.
Measured: Baseline to week 18
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.
Measured: Baseline to Day 7
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.
Measured: Baseline to Week 2
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.
Measured: Baseline to Week 3
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.
Measured: Baseline to Week 6
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.
Measured: Baseline to Week 9
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.
Measured: Baseline to Week 12
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.
Measured: Baseline to Week 15
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.
Measured: Baseline to Week 18
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.
Measured: Baseline to Week 18
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.
Measured: From Baseline to Week 18
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.
Measured: Baseline to Week 18.
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.
Measured: Baseline to Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study start23 May 2015
- Primary completionJan 2018
- Study completion4 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer and Chemotherapy Related AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453334
- Sponsor's protocol ID
- 1VIT14039
- Acronym
- IRON CLAD
- Status last verified
- May 2021
- First submitted
- 21 May 2015
- Last updated
- 11 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02453334
- Acronym / sponsor ID
- IRON CLAD / 1VIT14039
- Conditions
- Cancer and Chemotherapy Related Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 May 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- 4 Jan 2018 (actual)
- First posted
- 25 May 2015 (estimated)
- Results
- Posted 10 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injectafer | Experimental | Drug: Injectafer2 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 | Placebo comparator | Other: Normal SalineNormal saline administered as an infusion of no more than 250mL infused over 15 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InjectaferAlso: ferric carboxymaltose injection | Drug | Injectafer |
| Normal Saline | Other | Normal Saline |
Primary outcome
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: * 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.
18 secondary outcomes
Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
Time frame: 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
Percentage of Participants Who Received Nonstudy Intervention
Time frame: Baseline to week 18
Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention
Time frame: Baseline to week 18
Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention
Time frame: Baseline to Week 18
Percentage of Participants Requiring a Blood Transfusion
Time frame: Baseline to week 18
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Time frame: Baseline to Day 7
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Time frame: Baseline to Week 2
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Time frame: Baseline to Week 3
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Time frame: Baseline to Week 6
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Time frame: Baseline to Week 9
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
Time frame: Baseline to Week 12
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
Time frame: Baseline to Week 15
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Time frame: Baseline to Week 18
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
Time frame: 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
Correlation of Change in Hemoglobin With Baseline Hepcidin Level
Time frame: Baseline to Week 18.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
Related trials for Cancer and Chemotherapy Related Anemia
RecruitingPhase 2
Personalized NK Cell Therapy in CBT
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia
Active, not recruitingPhase 1/2
Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant
Acute Myeloid Leukemia in Remission, Adult Acute Lymphoblastic Leukemia in Complete Remission
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Injectafer and Normal Saline in people with Cancer and Chemotherapy Related Anemia, run by American Regent, Inc. at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.