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The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy or to IV iron therapy.
The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy for 28 days or to IV iron therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injectafer | Experimental | 2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg. |
|
| IV Iron Standard of Care (SOC) | Active Comparator | At a dose and administration regimen as determined by the study site investigator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injectafer | Drug | 2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Multidimensional Assessment of Fatigue (MAF) Scores | The MAF scale has 16 items that measure the Global Fatigue Index (GFI), a composite score of Items 1 through 15. Items 1 through 14 were measured on a scale of 1 to 10, with 1 = not at all and 10 = a great deal. Items 15 and 16 had categorical responses: degree of agreement from 0 to 4, with 0=no days and 4=every day. Then, a Global Fatigue Index (GFI) is calculated by summing specific items and averaging others. The final GFI score ranges from 1 (no fatigue) to 50 (severe fatigue). The resulting score is given as the mean value. | Baseline to Day 30 |
| Work Productivity and Activity Impairment Questionnaire (WPAI) Scores | The WPAI consisted of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working using a scale of 0 to 10, with 0 = PROBLEM had no effect on my work and 10 = PROBLEM completely prevented me from working; 6 = degree health affected productivity in regular unpaid activities using a scale of 0 to 10, with 0 = PROBLEM had no effect on my daily activities and 10 = PROBLEM completely prevented me from doing my daily activities. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. | Baseline and Day 30 |
| Treatment Satisfaction Questionnaire for Medication Version 1.4 Scores | Participants rated 14 items with 4 domains. Scores for item 1 to 3, 9 to 11 and 14 ranged from 1=extremely dissatisfied to 7=extremely satisfied. Items 5 to 8, 12, 13 ranged from 1=extremely dissatisfied to 5=not at all dissatisfied. Item 4 was scored as: 0=No, 1=Yes. Effectiveness measured as ([{sum of item 1 to 3} - 3]/18)*100; if 1 question (Q) was missing: ([{sum of item 1 to 3} -2]/12)*100. Side-effect measured as if item 4=No, score=100; if not then ([{sum of item 5 to 8} -4]/16)*100; if 1 Q was missing: ([{sum of item 5 to 8} -3]/12)*100. Convenience measured as ([{sum of item 9 to 11} -3]/18)*100; if 1 Q was missing: ([{sum of item 9 to 11} - 2]/12)*100. Global satisfaction as ([{sum of item 12 to 14} -3]/14)*100; if item 12 or 13 was missing: ([{sum of item 12 to 14} -2]/10)*100; if item 14 was missing: ([{sum of item 12 and 13} -2]/8)*100. All domains had scale of 0 (no satisfaction) to 100 (best level of satisfaction), higher score equals greater satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Falone, MD | American Regent, Inc. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Iron Standard of Care (SOC) | At a dose and administration regimen as determined by the study site investigator Standard of Care (SOC) |
| FG001 | Injectafer | 2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg. Injectafer: 2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Injectafer | 2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg. Injectafer: 2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg. |
| BG001 | IV Iron Standard of Care (SOC) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Multidimensional Assessment of Fatigue (MAF) Scores | The MAF scale has 16 items that measure the Global Fatigue Index (GFI), a composite score of Items 1 through 15. Items 1 through 14 were measured on a scale of 1 to 10, with 1 = not at all and 10 = a great deal. Items 15 and 16 had categorical responses: degree of agreement from 0 to 4, with 0=no days and 4=every day. Then, a Global Fatigue Index (GFI) is calculated by summing specific items and averaging others. The final GFI score ranges from 1 (no fatigue) to 50 (severe fatigue). The resulting score is given as the mean value. | Change from baseline to Day 30 | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 30 |
|
Day 1 to Day 30
Adverse events were collected by systematic assessment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Injectafer | 2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg. Injectafer: 2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | MedDRA 16.4 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 16.4 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Falone, MD. | American Regent, Inc. | 631.772.3544 | mfalone@americanregent.com |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
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| SOC | Drug |
|
|
| Baseline and Day 30 |
| Short Form Health Survey, 12-Item (SF-12) v2 Quality of Life Scores. | The SF-12 is a multipurpose short form to measure health status. There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means a better outcome. The overall scale and sub-scales were calculated with the standard SF-12 formulas. | Baseline and Day 30 |
| Physician Decision |
|
| Adverse Event |
|
| Death |
|
| Not Defined |
|
At a dose and administration regimen as determined by the study site investigator SOC |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | IV Iron Standard of Care (SOC) | At a dose and administration regimen as determined by the study site investigator SOC |
|
|
| Primary | Work Productivity and Activity Impairment Questionnaire (WPAI) Scores | The WPAI consisted of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working using a scale of 0 to 10, with 0 = PROBLEM had no effect on my work and 10 = PROBLEM completely prevented me from working; 6 = degree health affected productivity in regular unpaid activities using a scale of 0 to 10, with 0 = PROBLEM had no effect on my daily activities and 10 = PROBLEM completely prevented me from doing my daily activities. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. | Change from baseline to Day 30 | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 30 |
|
|
|
| Primary | Treatment Satisfaction Questionnaire for Medication Version 1.4 Scores | Participants rated 14 items with 4 domains. Scores for item 1 to 3, 9 to 11 and 14 ranged from 1=extremely dissatisfied to 7=extremely satisfied. Items 5 to 8, 12, 13 ranged from 1=extremely dissatisfied to 5=not at all dissatisfied. Item 4 was scored as: 0=No, 1=Yes. Effectiveness measured as ([{sum of item 1 to 3} - 3]/18)*100; if 1 question (Q) was missing: ([{sum of item 1 to 3} -2]/12)*100. Side-effect measured as if item 4=No, score=100; if not then ([{sum of item 5 to 8} -4]/16)*100; if 1 Q was missing: ([{sum of item 5 to 8} -3]/12)*100. Convenience measured as ([{sum of item 9 to 11} -3]/18)*100; if 1 Q was missing: ([{sum of item 9 to 11} - 2]/12)*100. Global satisfaction as ([{sum of item 12 to 14} -3]/14)*100; if item 12 or 13 was missing: ([{sum of item 12 to 14} -2]/10)*100; if item 14 was missing: ([{sum of item 12 and 13} -2]/8)*100. All domains had scale of 0 (no satisfaction) to 100 (best level of satisfaction), higher score equals greater satisfaction | Change from baseline to Day 30 | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 30 |
|
|
|
| Primary | Short Form Health Survey, 12-Item (SF-12) v2 Quality of Life Scores. | The SF-12 is a multipurpose short form to measure health status. There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means a better outcome. The overall scale and sub-scales were calculated with the standard SF-12 formulas. | Change from Baseline to Day 30 | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 30 |
|
|
|
| 1 |
| 513 |
| 4 |
| 513 |
| 28 |
| 513 |
| EG001 | IV Iron Standard of Care (SOC) | At a dose and administration regimen as determined by the study site investigator SOC | 1 | 512 | 1 | 512 | 21 | 512 |
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| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Percent impairment while working due to problem |
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| Percent overall work impairment due to problem |
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| Percent work time missed due to problem |
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| Effectiveness |
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| Side Effects |
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| Convenience |
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| Overall Physical Health Score |
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| Overall Mental Health Score |
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| Physical Functioning |
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| Role Limitation Physical |
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| General Health |
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| Vitality |
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| Social Functioning |
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| Role Limitation Emotion |
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| Mental Health |
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