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CompletedNCT02453334IRON CLADUpdated May 11, 2021Results posted

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

A Phase 3 interventional study of Injectafer and Normal Saline in Cancer and Chemotherapy Related Anemia, sponsored by American Regent, Inc.. Completed at 29 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-11.

Sponsored by American Regent, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
244
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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).

02

Conditions studied

  • Cancer and Chemotherapy Related Anemia

Browse trials for

03

In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's enrollment of 244 is above the median of 94 across 1,291 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

American Regent, Inc. is the lead sponsor of 53 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
244 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Normal Saline

    Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.

    Other: Normal Saline

Interventions

  • DrugInjectafer

    Also known as: ferric carboxymaltose injection

  • OtherNormal Saline
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Week 3 to Week 18

Secondary outcomes

  1. 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

    Time frame: Baseline to Week 18

  2. 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.

    Time frame: Baseline to Week 18

  3. 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

    Time frame: Baseline to week 18

  4. 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 frame: Baseline to week 18

  5. 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

    Time frame: Baseline to Week 18

  6. Percentage of Participants Requiring a Blood Transfusion

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

    Time frame: Baseline to week 18

  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.

    Time frame: Baseline to Day 7

  8. 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 frame: Baseline to Week 2

  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.

    Time frame: Baseline to Week 3

  10. 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 frame: Baseline to Week 6

  11. 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 frame: Baseline to Week 9

  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.

    Time frame: Baseline to Week 12

  13. 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 frame: Baseline to Week 15

  14. 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 frame: Baseline to Week 18

  15. 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 frame: Baseline to Week 18

  16. 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 frame: From Baseline to Week 18

  17. 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.

    Time frame: Baseline to Week 18.

  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.

    Time frame: Baseline to Week 18

07

Results

Posted May 10, 2021

Participant flow

Participant flow — Overall Study
MilestoneInjectaferNormal Saline
Started122122
Completed8182
Not completed4140
Withdrew: Death1513
Withdrew: Adverse event21
Withdrew: Lost to follow-up59
Withdrew: Physician decision10
Withdrew: Withdrawal by subject1713
Withdrew: Other reason14

Outcome measures

PrimaryPercentage 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.

Time frame:
Week 3 to Week 18
Reported as:
Count of participants · Participants
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18
ParticipantsInjectaferNormal Saline
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 184260
Statistical analysis
  • Injectafer vs Normal Saline · Cochran-Mantel-Haenszel · p = 0.0143 · Odds ratio (or): 0.51 · 95% CI 0.30 to 0.87
  • Injectafer vs Normal Saline · Percentage difference: -15.6 · 95% CI -28.01 to -3.10
SecondaryChange 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

Time frame:
Baseline to Week 18
Reported as:
Mean · g/dL
Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
g/dLInjectaferNormal Saline
Baseline9.63 ± 1.0009.75 ± 1.008
Day 7 Change from Baseline0.27 ± 0.9010.01 ± 0.741
Week 2 Change from Baseline0.53 ± 1.0770.06 ± 0.937
Week 3 Change from Baseline0.58 ± 1.0150.04 ± 1.028
Week 6 Change from Baseline0.84 ± 1.2640.07 ± 1.254
Week 9 Change from Baseline0.85 ± 1.1740.37 ± 1.512
Week 12 Change from Baseline1.00 ± 1.2020.74 ± 1.274
Week 15 Change from Baseline0.97 ± 1.3940.79 ± 1.313
Week 18/ET Change from Baseline1.04 ± 1.7180.87 ± 1.475
SecondaryPercentage 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.

Time frame:
Baseline to Week 18
Reported as:
Count of participants · Participants
Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention
ParticipantsInjectaferNormal Saline
Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention8464
Statistical analysis
  • Injectafer vs Normal Saline · Cochran-Mantel-Haenszel · p = 0.0097 · Odds ratio (or): 2.04 · 95% CI 1.19 to 3.50
  • Injectafer vs Normal Saline · Percentage difference: 16.4 · 95% CI 4.19 to 28.51
SecondaryPercentage 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

Time frame:
Baseline to week 18
Reported as:
Count of participants · Participants
Percentage of Participants Who Received Nonstudy Intervention
ParticipantsInjectaferNormal Saline
Percentage of Participants Who Received Nonstudy Intervention2225
Statistical analysis
  • Injectafer vs Normal Saline · Percentage difference: -2.7 · 95% CI -12.85 to 7.45
  • Injectafer vs Normal Saline · Cochran-Mantel-Haenszel · p = 0.5758 · Odds ratio (or): 0.83 · 95% CI 0.43 to 1.60
SecondaryPercentage 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 frame:
Baseline to week 18
Reported as:
Count of participants · Participants
Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention
ParticipantsInjectaferNormal Saline
Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention3124
Statistical analysis
  • Injectafer vs Normal Saline · Cochran-Mantel-Haenszel · p = 0.2772 (Placebo group was used as the denominator for odds ratio calculation) · Odds ratio (or): 1.40 · 95% CI 0.76 to 2.56
  • Injectafer vs Normal Saline · Percentage difference: 5.7 · 95% CI -5.01 to 16.43
SecondaryTime 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

Time frame:
Baseline to Week 18
Reported as:
Number · Days
Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention
DaysInjectaferNormal Saline
Q1, 1st quartile15 (15 to 20)23 (21 to 43)
Q2, 2nd quartile or median43 (22 to 45)85 (64 to 106)
Q3, 3rd quartile106 (69 to NA)NA (126 to NA)
Statistical analysis
  • Injectafer vs Normal Saline · Log Rank · p = 0.0011P-value was estimated using logrank test stratified by country
SecondaryPercentage of Participants Requiring a Blood Transfusion

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

Time frame:
Baseline to week 18
Reported as:
Count of participants · Participants
Percentage of Participants Requiring a Blood Transfusion
ParticipantsInjectaferNormal Saline
Percentage of Participants Requiring a Blood Transfusion1514
Statistical analysis
  • Injectafer vs Normal Saline · Percentage difference: 0.7 · 95% CI -7.60 to 9.08
  • Injectafer vs Normal Saline · Cochran-Mantel-Haenszel · p = 0.8924 · Odds ratio (or): 1.05 · 95% CI 0.49 to 2.29
SecondaryPercentage 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 frame:
Baseline to Day 7
Reported as:
Count of participants · Participants
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
ParticipantsInjectaferNormal Saline
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit1829
Statistical analysis
  • Injectafer vs Normal Saline · Percentage difference: -9.8 · 95% CI -20.41 to 0.77
  • Injectafer vs Normal Saline · Cochran-Mantel-Haenszel · p = 0.0740 · Odds ratio (or): 0.55 · 95% CI 0.28 to 1.06Placebo group was used as the denominator for odds ratio calculation.
SecondaryPercentage 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 frame:
Baseline to Week 2
Reported as:
Count of participants · Participants
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
ParticipantsInjectaferNormal Saline
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit1728
Statistical analysis
  • Injectafer vs Normal Saline · Percentage difference: -12.1 · 95% CI -23.31 to -0.91
  • Injectafer vs Normal Saline · Cochran-Mantel-Haenszel · p = 0.0446 (The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.) · Odds ratio (or): 0.51 · 95% CI 0.26 to 0.99Placebo group was used as the denominator for odds ratio calculation
SecondaryPercentage 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 frame:
Baseline to Week 3
Reported as:
Count of participants · Participants
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
ParticipantsInjectaferNormal Saline
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit1233
Statistical analysis
  • Injectafer vs Normal Saline · Percentage difference: -19.8 · 95% CI -30.90 to -8.69
  • Injectafer vs Normal Saline · Cochran-Mantel-Haenszel · p = 0.0010 (The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.) · Odds ratio (or): 0.30 · 95% CI 0.14 to 0.63Placebo group was used as the denominator for odds ratio calculation.
SecondaryPercentage 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 frame:
Baseline to Week 6
Reported as:
Count of participants · Participants
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
ParticipantsInjectaferNormal Saline
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit1232
Statistical analysis
  • Injectafer vs Normal Saline · Percentage difference: -21.4 · 95% CI -33.22 to -9.51
  • Injectafer vs Normal Saline · Cochran-Mantel-Haenszel · p = 0.0009 (The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country) · Odds ratio (or): 0.29 · 95% CI 0.13 to 0.61Placebo group was used as the denominator for odds ratio calculation.
SecondaryPercentage 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 frame:
Baseline to Week 9
Reported as:
Count of participants · Participants
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
ParticipantsInjectaferNormal Saline
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit921
Statistical analysis
  • Injectafer vs Normal Saline · Percentage difference: -16.0 · 95% CI -27.73 to -4.26
  • Injectafer vs Normal Saline · Cochran-Mantel-Haenszel · p = 0.0093 (The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.) · Odds ratio (or): 0.34 · 95% CI 0.14 to 0.79Placebo group was used as the denominator for odds ratio calculation.
SecondaryPercentage 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 frame:
Baseline to Week 12
Reported as:
Count of participants · Participants
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
ParticipantsInjectaferNormal Saline
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.810
Statistical analysis
  • Injectafer vs Normal Saline · Percentage difference: -4.4 · 95% CI -15.37 to 6.57
  • Injectafer vs Normal Saline · Cochran-Mantel-Haenszel · p = 0.4786 (The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.) · Odds ratio (or): 0.70 · 95% CI 0.26 to 1.89Placebo group was used as the denominator for odds ratio calculation.
SecondaryPercentage 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 frame:
Baseline to Week 15
Reported as:
Count of participants · Participants
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
ParticipantsInjectaferNormal Saline
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.812
Statistical analysis
  • Injectafer vs Normal Saline · Percentage difference: -7.4 · 95% CI -19.25 to 4.55
  • Injectafer vs Normal Saline · Cochran-Mantel-Haenszel · p = 0.2084 (The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.) · Odds ratio (or): 0.54 · 95% CI 0.20 to 1.43Placebo group was used as the denominator for odds ratio calculation.
SecondaryPercentage 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 frame:
Baseline to Week 18
Reported as:
Count of participants · Participants
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
ParticipantsInjectaferNormal Saline
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit129
Statistical analysis
  • Injectafer vs Normal Saline · Percentage difference: 3.1 · 95% CI -9.33 to 15.54
  • Injectafer vs Normal Saline · Cochran-Mantel-Haenszel · p = 0.6508 · Odds ratio (or): 1.25 · 95% CI 0.48 to 3.24Placebo group was used as the denominator for odds ratio calculation.
SecondaryTime 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 frame:
Baseline to Week 18
Reported as:
Number · Days
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
DaysInjectaferNormal Saline
Q115 (14 to 43)14 (8 to 15)
Q2127 (106 to NA)43 (22 to 64)
SecondaryTime 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 frame:
From Baseline to Week 18
Reported as:
Number · Days
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
DaysInjectaferNormal Saline
Q1,1st quartile15 (14 to 43)14 (8 to 15)
2nd quartile or median127 (106 to NA)43 (22 to 64)
Q3, 3rd quartileNA (NA to NA)NA (128 to NA)
Statistical analysis
  • Injectafer vs Normal Saline · Log Rank · p = 0.0063 (P-value was estimated using logrank test stratified by pooled sites.)
SecondaryCorrelation 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.

Time frame:
Baseline to Week 18.
Reported as:
Mean · g/dL
Correlation of Change in Hemoglobin With Baseline Hepcidin Level
g/dLInjectaferNormal Saline
Hepcidin in 1st Tertile0.88 ± 1.8921.13 ± 1.203
hepcidin in 3rd Tertile1.28 ± 1.5520.02 ± 1.394
SecondaryTotal 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.

Time frame:
Baseline to Week 18
Reported as:
Mean · Score on a scale
Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18
Score on a scaleInjectaferNormal Saline
Baseline21.8 ± 9.4721.5 ± 8.64
Day 7 Change from Baseline-0.8 ± 6.78-0.7 ± 6.21
Week 2 Change from Baseline-0.3 ± 7.340.2 ± 8.13
Week 3 Change from Baseline-0.3 ± 7.75-0.6 ± 7.41
Week 6 Change from Baseline-0.2 ± 9.70-0.7 ± 8.13
Week 9 Change from Baseline-0.7 ± 8.350.3 ± 8.22
Week 12 Change from Baseline-0.1 ± 9.82-0.5 ± 8.09
Week 15 Change from Baseline-0.1 ± 9.650.8 ± 9.11
Week 18 Change from Baseline-1.5 ± 8.780.0 ± 8.92

Adverse events

Collected over 1 year, 7 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Injectafer0/121 (0%)28/121 (23.1%)96/121 (79.3%)
Normal Saline0/118 (0%)22/118 (18.6%)95/118 (80.5%)
Most frequent serious events
Most frequent serious events
EventInjectaferNormal Saline
Gastrointestinal DisordersGastrointestinal disorders7/1210/118
Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)6/1211/118
Respiratory, Thoracic and Mediastinal DisordersRespiratory, thoracic and mediastinal disorders5/1213/118
Disease progressionGeneral disorders4/1214/118
Blood And Lymphatic System DisordersBlood and lymphatic system disorders4/1213/118
Infections And InfestationsInfections and infestations4/1213/118
Cardiac DisordersCardiac disorders2/1213/118
Hepatobiliary DisordersHepatobiliary disorders0/1213/118
Renal And Urinary DisordersRenal and urinary disorders3/1212/118
Most frequent other events
Showing 10 of 25
Most frequent other events
EventInjectaferNormal Saline
NeutropeniaBlood and lymphatic system disorders21/12114/118
HypophosphatemiaMetabolism and nutrition disorders19/1213/118
FatigueGeneral disorders18/12117/118
Respiratory, Thoracic and Mediastinal DisordersRespiratory, thoracic and mediastinal disorders11/12117/118
Infections and InfestationsInfections and infestations16/12114/118
DiarrhoeaGastrointestinal disorders15/1218/118
LeukopeniaBlood and lymphatic system disorders15/12113/118
NauseaGastrointestinal disorders11/12111/118
AstheniaGeneral disorders10/12111/118
PyrexiaGeneral disorders6/12111/118

Baseline characteristics

Age, Continuous
Age, Continuous(years)InjectaferNormal SalineTotal
Mean63.0 ± 10.0263.1 ± 9.2663.0 ± 9.63
Sex: Female, Male
Sex: Female, Male(Participants)InjectaferNormal SalineTotal
Female6769136
Male5553108
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)InjectaferNormal SalineTotal
Hispanic or Latino3710
Not Hispanic or Latino119115234
Unknown or Not Reported000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)InjectaferNormal SalineTotal
Race — White117112229
Race — Black/African-American5813
Race — Multiple022
Race — American Indian/Alaska Native000
Race — Asian000
Race — Native Hawaiian/Other Pacific Islander000
Region of Enrollment
Region of Enrollment(Participants)InjectaferNormal SalineTotal
United States222244
Georgia393877
Hungary262753
Poland242448
Bulgaria111122
Height
Height(cm)InjectaferNormal SalineTotal
Mean166.9 ± 9.5165.9 ± 9.6166.4 ± 9.5
Iron intolerance
Iron intolerance(Participants)InjectaferNormal SalineTotal
Yes336
No119119238
ECOG grade
ECOG grade(Participants)InjectaferNormal SalineTotal
0393069
17583158
28917
3000
4000

1 further baseline measures are reported on the registry.

08

Study locations

29 sites
  • Compassionate Care Research Group, Inc.
    Corona, California 92879, United States
  • Compassionate Care Research Group, Inc.
    Fountain Valley, California 92708, United States
  • Compassionate Care Research Group, Inc.
    Riverside, California 92501, United States
  • University Cancer Institute
    Boynton Beach, Florida 33426, United States
  • AR Development Solutions
    Miami Lakes, Florida 33014, United States
  • Lakes Research
    Miami Lakes, Florida 33014, United States
  • H. Lee Moffitt Cancer Center
    Tampa, Florida 33606, United States
  • Bond Bond Clinic, P.A.
    Winter Haven, Florida 33880, United States
  • Joliet Oncology Hematology Associates
    Joliet, Illinois 60435, United States
  • MId-Illinois Hematology & Oncology Associates, Ltd.
    Normal, Illinois 61761, United States
  • OSF Saint Anthony Medical Center for Cancer Care
    Rockford, Illinois 61108, United States
  • Horizon Oncology Research, Inc.
    Lafayette, Indiana 47905, United States
  • Michiana Hematology Oncology, PC
    South Bend, Indiana 46628, United States
  • Northern Indiana Cancer Research Consortium
    South Bend, Indiana 46628, United States
  • Ashland-Bellefonte Cancer Center
    Ashland, Kentucky 41101, United States
  • Rcca Md, Llc
    Bethesda, Maryland 20817, United States
  • Antietam Oncology and Hematology Group, P.C.
    Hagerstown, Maryland 21740, United States
  • North Mississippi and Oncology Associates
    Tupelo, Mississippi 38801, United States
  • Montefiore Medical Center
    Bronx, New York 10467, United States
  • East Chester Cancer Center
    Bronx, New York 10469, United States
  • The Brookdale University Hospital and Medical Center
    Brooklyn, New York 11212, United States
  • Richmond University Medical Center
    Staten Island, New York 10310, United States
  • Waverly Hematology Oncology
    Cary, North Carolina 27518, United States
  • Kinston Medical Specialists
    Kinston, North Carolina 28501, United States
  • Gettysburg Cancer Center
    Gettysburg, Pennsylvania 17325, United States
  • Charleston Hematology/Oncology Associates, P.A.
    Charleston, South Carolina 29414, United States
  • Carolina Blood and Cancer Care, PA
    Rock Hill, South Carolina 29732, United States
  • Westchase Clinical Associates
    Houston, Texas 77042, United States
  • Bon Secours St. Francis Medical Center
    Midlothian, Virginia 23114, United States
09

References and documents

Study documents

  • Study protocol · Nov 2, 2017
  • Statistical analysis plan · Jan 3, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02453334
Lead sponsor
American Regent, Inc.
Responsible party
Sponsor
First posted
May 25, 2015
Start date
May 23, 2015
Primary completion
Jan 2018
Completion
Jan 4, 2018
Results posted
May 10, 2021
Last update
May 11, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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