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Completed

NCT Number: NCT02453334

Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®

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.

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Key information

Conditions

Cancer and Chemotherapy Related Anemia Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Compassionate Care Research Group, Inc., Corona, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Injectafer

Drug

Other names: ferric carboxymaltose injection

Normal Saline

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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:

    • Initiation of erythropoietin for any reason
    • Blood transfusion
    • IV iron
    • Prescribed use of oral iron

  2. 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.

  3. Percentage of Participants Who Received Nonstudy Intervention

    Time frame: Baseline to week 18

    Intervention is defined as any of the following:

    • Initiation of erythropoietin for any reason
    • Blood transfusion
    • IV iron
    • Prescribed use of oral iron

  4. 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:

    • Initiation of erythropoietin for any reason
    • Blood transfusion
    • IV iron
    • Prescribed use of oral iron

  5. 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

  6. Percentage of Participants Requiring a Blood Transfusion

    Time frame: Baseline to week 18

    Summary of the number (percentage) of participants requiring a blood transfusion at any time during the trial.

  7. Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit

    Time frame: Baseline to Day 7

    Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.

  8. Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit

    Time frame: Baseline to Week 2

    Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.

  9. 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.

  10. Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit

    Time frame: Baseline to Week 6

    Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.

  11. Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit

    Time frame: Baseline to Week 9

    Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.

  12. Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.

    Time frame: Baseline to Week 12

    Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.

  13. Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.

    Time frame: Baseline to Week 15

    Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.

  14. Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit

    Time frame: Baseline to Week 18

    Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.

  15. 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.

  16. 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.

  17. Correlation of Change in Hemoglobin With Baseline Hepcidin Level

    Time frame: Baseline to Week 18.

    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.

  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

    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.

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Official study 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

Acronym: IRON CLAD

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 25, 2015
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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