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

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: Cancer and Chemotherapy Related Anemia
• Intervention / Treatment: Other: Normal Saline; Drug: Injectafer

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

Study Locations

• United States
  • California
    • Corona, California, United States, 92879
      • Compassionate Care Research Group, Inc.
    • Fountain Valley, California, United States, 92708
      • Compassionate Care Research Group, Inc.
    • Riverside, California, United States, 92501
      • Compassionate Care Research Group, Inc.
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • University Cancer Institute
    • Miami Lakes, Florida, United States, 33014
      • Lakes Research
    • Miami Lakes, Florida, United States, 33014
      • AR Development Solutions
    • Tampa, Florida, United States, 33606
      • H. Lee Moffitt Cancer Center
    • Winter Haven, Florida, United States, 33880
      • Bond Bond Clinic, P.A.
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Joliet Oncology Hematology Associates
    • Normal, Illinois, United States, 61761
      • Mid-Illinois Hematology & Oncology Associates, Ltd.
    • Rockford, Illinois, United States, 61108
      • OSF Saint Anthony Medical Center for Cancer Care
  • Indiana
    • Lafayette, Indiana, United States, 47905
      • Horizon Oncology Research, Inc.
    • South Bend, Indiana, United States, 46628
      • Northern Indiana Cancer Research Consortium
    • South Bend, Indiana, United States, 46628
      • Michiana Hematology Oncology, PC
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • Ashland-Bellefonte Cancer Center
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Rcca Md, Llc
    • Hagerstown, Maryland, United States, 21740
      • Antietam Oncology and Hematology Group, P.C.
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi and Oncology Associates
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Bronx, New York, United States, 10469
      • East Chester Cancer Center
    • Brooklyn, New York, United States, 11212
      • The Brookdale University Hospital and Medical Center
    • Staten Island, New York, United States, 10310
      • Richmond University Medical Center
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Waverly Hematology Oncology
    • Kinston, North Carolina, United States, 28501
      • Kinston Medical Specialists
  • Pennsylvania
    • Gettysburg, Pennsylvania, United States, 17325
      • Gettysburg Cancer Center
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Hematology/Oncology Associates, P.A.
    • Rock Hill, South Carolina, United States, 29732
      • Carolina Blood and Cancer Care, PA
  • Texas
    • Houston, Texas, United States, 77042
      • Westchase Clinical Associates
  • Virginia
    • Midlothian, Virginia, United States, 23114
      • Bon Secours St. Francis Medical Center

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

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.	Drug: Injectafer; Other Names: ferric carboxymaltose injection
Placebo Comparator: Normal Saline; Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.	Other: Normal Saline

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	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.	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	Nonstudy Intervention is defined as any of the following: Initiation of erythropoietin for any reason; Blood transfusion; IV iron; Prescribed use of oral iron	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.	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	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	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	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline to Week 18

Collaborators and Investigators

• Sponsor: American Regent, Inc.

Study record dates

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: Hematologic Diseases; Anemia
• Other Study ID Numbers: 1VIT14039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES