Cancer and Chemotherapy Related Anemia
Conditions
Brief 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.
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).
Interventions
DRUGInjectafer
OTHERNormal Saline
Sponsors
American Regent, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18 | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention | 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. |
| Percentage of Participants Who Received Nonstudy Intervention | 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 |
| Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention | 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 |
| Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention | 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 |
| Percentage of Participants Requiring a Blood Transfusion | Baseline to week 18 | Summary of the number (percentage) of participants requiring a blood transfusion at any time during the trial. |
| Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | 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 |
| Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit. | Baseline to Week 12 | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. |
| Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 | 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. |
| Correlation of Change in Hemoglobin With Baseline Hepcidin Level | 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. |
| Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | 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. |
| Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | Baseline to Day 7 | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Injectafer | 122 |
| Normal Saline Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline | 122 |
| Total | 244 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Death | 15 | 13 |
| Overall Study | Lost to Follow-up | 5 | 9 |
| Overall Study | Other reason | 1 | 4 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 17 | 13 |
Baseline characteristics
| Characteristic | Injectafer | Total | Normal Saline |
|---|---|---|---|
| Age, Continuous | 63.0 years STANDARD_DEVIATION 10.02 | 63.0 years STANDARD_DEVIATION 9.63 | 63.1 years STANDARD_DEVIATION 9.26 |
| Cancer stage 0 | 2 Participants | 2 Participants | 0 Participants |
| Cancer stage 1 | 0 Participants | 0 Participants | 0 Participants |
| Cancer stage 2 | 2 Participants | 9 Participants | 7 Participants |
| Cancer stage 3 | 9 Participants | 21 Participants | 12 Participants |
| Cancer stage 4 | 81 Participants | 150 Participants | 69 Participants |
| Cancer stage Unknown | 28 Participants | 62 Participants | 34 Participants |
| ECOG grade 0 | 39 Participants | 69 Participants | 30 Participants |
| ECOG grade 1 | 75 Participants | 158 Participants | 83 Participants |
| ECOG grade 2 | 8 Participants | 17 Participants | 9 Participants |
| ECOG grade 3 | 0 Participants | 0 Participants | 0 Participants |
| ECOG grade 4 | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 10 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 119 Participants | 234 Participants | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 166.9 cm STANDARD_DEVIATION 9.5 | 166.4 cm STANDARD_DEVIATION 9.5 | 165.9 cm STANDARD_DEVIATION 9.6 |
| Iron intolerance No | 119 Participants | 238 Participants | 119 Participants |
| Iron intolerance Yes | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Race American Indian/Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black/African-American | 5 Participants | 13 Participants | 8 Participants |
| Race/Ethnicity, Customized Race Multiple | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian/Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race White | 117 Participants | 229 Participants | 112 Participants |
| Region of Enrollment Bulgaria | 11 Participants | 22 Participants | 11 Participants |
| Region of Enrollment Georgia | 39 Participants | 77 Participants | 38 Participants |
| Region of Enrollment Hungary | 26 Participants | 53 Participants | 27 Participants |
| Region of Enrollment Poland | 24 Participants | 48 Participants | 24 Participants |
| Region of Enrollment United States | 22 Participants | 44 Participants | 22 Participants |
| Sex: Female, Male Female | 67 Participants | 136 Participants | 69 Participants |
| Sex: Female, Male Male | 55 Participants | 108 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 121 | 0 / 118 |
| other Total, other adverse events | 96 / 121 | 95 / 118 |
| serious Total, serious adverse events | 28 / 121 | 22 / 118 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Injectafer | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18 | 42 Participants |
| Normal Saline | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18 | 60 Participants |
p-value: 0.014395% CI: [0.3, 0.87]Cochran-Mantel-Haenszel
95% CI: [-28.01, -3.1]
Secondary
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
Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Injectafer | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Day 7 Change from Baseline | 0.27 g/dL | Standard Deviation 0.901 |
| Injectafer | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Week 9 Change from Baseline | 0.85 g/dL | Standard Deviation 1.174 |
| Injectafer | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Week 3 Change from Baseline | 0.58 g/dL | Standard Deviation 1.015 |
| Injectafer | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Week 12 Change from Baseline | 1.00 g/dL | Standard Deviation 1.202 |
| Injectafer | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Week 2 Change from Baseline | 0.53 g/dL | Standard Deviation 1.077 |
| Injectafer | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Week 15 Change from Baseline | 0.97 g/dL | Standard Deviation 1.394 |
| Injectafer | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Week 6 Change from Baseline | 0.84 g/dL | Standard Deviation 1.264 |
| Injectafer | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Week 18/ET Change from Baseline | 1.04 g/dL | Standard Deviation 1.718 |
| Injectafer | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Baseline | 9.63 g/dL | Standard Deviation 1 |
| Normal Saline | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Week 18/ET Change from Baseline | 0.87 g/dL | Standard Deviation 1.475 |
| Normal Saline | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Baseline | 9.75 g/dL | Standard Deviation 1.008 |
| Normal Saline | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Day 7 Change from Baseline | 0.01 g/dL | Standard Deviation 0.741 |
| Normal Saline | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Week 2 Change from Baseline | 0.06 g/dL | Standard Deviation 0.937 |
| Normal Saline | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Week 3 Change from Baseline | 0.04 g/dL | Standard Deviation 1.028 |
| Normal Saline | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Week 6 Change from Baseline | 0.07 g/dL | Standard Deviation 1.254 |
| Normal Saline | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Week 9 Change from Baseline | 0.37 g/dL | Standard Deviation 1.512 |
| Normal Saline | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Week 12 Change from Baseline | 0.74 g/dL | Standard Deviation 1.274 |
| Normal Saline | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Week 15 Change from Baseline | 0.79 g/dL | Standard Deviation 1.313 |
Secondary
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.
Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Injectafer | Correlation of Change in Hemoglobin With Baseline Hepcidin Level | Hepcidin in 1st Tertile | 0.88 g/dL | Standard Deviation 1.892 |
| Injectafer | Correlation of Change in Hemoglobin With Baseline Hepcidin Level | hepcidin in 3rd Tertile | 1.28 g/dL | Standard Deviation 1.552 |
| Normal Saline | Correlation of Change in Hemoglobin With Baseline Hepcidin Level | Hepcidin in 1st Tertile | 1.13 g/dL | Standard Deviation 1.203 |
| Normal Saline | Correlation of Change in Hemoglobin With Baseline Hepcidin Level | hepcidin in 3rd Tertile | 0.02 g/dL | Standard Deviation 1.394 |
Secondary
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
Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Injectafer | Percentage of Participants Requiring a Blood Transfusion | 15 Participants |
| Normal Saline | Percentage of Participants Requiring a Blood Transfusion | 14 Participants |
95% CI: [-7.6, 9.08]
p-value: 0.892495% CI: [0.49, 2.29]Cochran-Mantel-Haenszel
Secondary
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
Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Injectafer | Percentage of Participants Who Received Nonstudy Intervention | 22 Participants |
| Normal Saline | Percentage of Participants Who Received Nonstudy Intervention | 25 Participants |
95% CI: [-12.85, 7.45]
Comparison: Placebo group was used as the denominator for odds ratio calculation.p-value: 0.575895% CI: [0.43, 1.6]Cochran-Mantel-Haenszel
Secondary
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
Population: Only participant with both a baseline and at least one post baseline value at Week 3 are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Injectafer | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | 12 Participants |
| Normal Saline | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | 33 Participants |
95% CI: [-30.9, -8.69]
p-value: 0.00195% CI: [0.14, 0.63]Cochran-Mantel-Haenszel
Secondary
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
Population: Only participant with both a baseline and at least one post baseline value at Day 7 are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Injectafer | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | 18 Participants |
| Normal Saline | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | 29 Participants |
95% CI: [-20.41, 0.77]
Comparison: The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country. Placebo group was used as the denominator for odds ratio calculation.p-value: 0.07495% CI: [0.28, 1.06]Cochran-Mantel-Haenszel
Secondary
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
Population: Only participant with both a baseline and at least one post baseline value at Week 2 are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Injectafer | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | 17 Participants |
| Normal Saline | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | 28 Participants |
95% CI: [-23.31, -0.91]
p-value: 0.044695% CI: [0.26, 0.99]Cochran-Mantel-Haenszel
Secondary
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
Population: Only participant with both a baseline and at least one post baseline value at Week 6 are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Injectafer | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | 12 Participants |
| Normal Saline | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | 32 Participants |
95% CI: [-33.22, -9.51]
p-value: 0.000995% CI: [0.13, 0.61]Cochran-Mantel-Haenszel
Secondary
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
Population: Only participant with both a baseline and at least one post baseline value at Week 9 are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Injectafer | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | 9 Participants |
| Normal Saline | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | 21 Participants |
95% CI: [-27.73, -4.26]
p-value: 0.009395% CI: [0.14, 0.79]Cochran-Mantel-Haenszel
Secondary
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
Population: Only participant with both a baseline and at least one post baseline value at Week 18 are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Injectafer | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | 12 Participants |
| Normal Saline | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | 9 Participants |
95% CI: [-9.33, 15.54]
p-value: 0.650895% CI: [0.48, 3.24]Cochran-Mantel-Haenszel
Secondary
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
Population: Only participant with both a baseline and at least one post baseline value at Week 12 are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Injectafer | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit. | 8 Participants |
| Normal Saline | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit. | 10 Participants |
95% CI: [-15.37, 6.57]
p-value: 0.478695% CI: [0.26, 1.89]Cochran-Mantel-Haenszel
Secondary
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
Population: Only participant with both a baseline and at least one post baseline value at Week 15 are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Injectafer | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit. | 8 Participants |
| Normal Saline | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit. | 12 Participants |
95% CI: [-19.25, 4.55]
p-value: 0.208495% CI: [0.2, 1.43]Cochran-Mantel-Haenszel
Secondary
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
Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Injectafer | Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention | 31 Participants |
| Normal Saline | Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention | 24 Participants |
p-value: 0.277295% CI: [0.76, 2.56]Cochran-Mantel-Haenszel
95% CI: [-5.01, 16.43]
Secondary
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
Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Injectafer | Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention | 84 Participants |
| Normal Saline | Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention | 64 Participants |
p-value: 0.009795% CI: [1.19, 3.5]Cochran-Mantel-Haenszel
Comparison: Percentage difference95% CI: [4.19, 28.51]
Secondary
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
Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Injectafer | Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 | Q1,1st quartile | 15 Days |
| Injectafer | Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 | 2nd quartile or median | 127 Days |
| Injectafer | Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 | Q3, 3rd quartile | NA Days |
| Normal Saline | Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 | Q1,1st quartile | 14 Days |
| Normal Saline | Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 | 2nd quartile or median | 43 Days |
| Normal Saline | Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 | Q3, 3rd quartile | NA Days |
p-value: 0.0063Log Rank
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Injectafer | Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 | Q1 | 15 Days |
| Injectafer | Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 | Q2 | 127 Days |
| Normal Saline | Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 | Q1 | 14 Days |
| Normal Saline | Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 | Q2 | 43 Days |
Secondary
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
Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Injectafer | Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention | Q1, 1st quartile | 15 Days |
| Injectafer | Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention | Q2, 2nd quartile or median | 43 Days |
| Injectafer | Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention | Q3, 3rd quartile | 106 Days |
| Normal Saline | Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention | Q1, 1st quartile | 23 Days |
| Normal Saline | Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention | Q2, 2nd quartile or median | 85 Days |
| Normal Saline | Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention | Q3, 3rd quartile | NA Days |
p-value: 0.0011Log Rank
Secondary
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
Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Injectafer | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Day 7 Change from Baseline | -0.8 Score on a scale | Standard Deviation 6.78 |
| Injectafer | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Week 9 Change from Baseline | -0.7 Score on a scale | Standard Deviation 8.35 |
| Injectafer | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Week 3 Change from Baseline | -0.3 Score on a scale | Standard Deviation 7.75 |
| Injectafer | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Week 12 Change from Baseline | -0.1 Score on a scale | Standard Deviation 9.82 |
| Injectafer | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Week 2 Change from Baseline | -0.3 Score on a scale | Standard Deviation 7.34 |
| Injectafer | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Week 15 Change from Baseline | -0.1 Score on a scale | Standard Deviation 9.65 |
| Injectafer | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Week 6 Change from Baseline | -0.2 Score on a scale | Standard Deviation 9.7 |
| Injectafer | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Week 18 Change from Baseline | -1.5 Score on a scale | Standard Deviation 8.78 |
| Injectafer | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Baseline | 21.8 Score on a scale | Standard Deviation 9.47 |
| Normal Saline | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Week 18 Change from Baseline | 0.0 Score on a scale | Standard Deviation 8.92 |
| Normal Saline | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Baseline | 21.5 Score on a scale | Standard Deviation 8.64 |
| Normal Saline | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Day 7 Change from Baseline | -0.7 Score on a scale | Standard Deviation 6.21 |
| Normal Saline | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Week 2 Change from Baseline | 0.2 Score on a scale | Standard Deviation 8.13 |
| Normal Saline | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Week 3 Change from Baseline | -0.6 Score on a scale | Standard Deviation 7.41 |
| Normal Saline | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Week 6 Change from Baseline | -0.7 Score on a scale | Standard Deviation 8.13 |
| Normal Saline | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Week 9 Change from Baseline | 0.3 Score on a scale | Standard Deviation 8.22 |
| Normal Saline | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Week 12 Change from Baseline | -0.5 Score on a scale | Standard Deviation 8.09 |
| Normal Saline | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Week 15 Change from Baseline | 0.8 Score on a scale | Standard Deviation 9.11 |