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The primary objective of this study is to evaluate the treatment response of Injectafer vs. oral iron to baseline hepcidin levels to determine if any of these select IBD or Gastric Bypass patients may demonstrate to be inappropriate for oral iron therapy.
The primary objective of this study is to evaluate the treatment response of Injectafer vs. oral iron in patients with varying hepcidin levels correlating the treatment response/hepcidin levels to more common laboratory parameters such as ferritin and CRP (C-Reactive Protein) levels and possibly determine if any of these select IBD or Gastric Bypass patients may demonstrate to be inappropriate for oral iron therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injectafer | Active Comparator | 2 doses of Injectafer, at 15 mg/kg for a maximum single dose of 750 mg given on Days 0 and 7 for a total of up to 1500 mg |
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| Ferrous Sulfate tablets | Active Comparator | Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injectafer | Drug | 2 doses of Injectafer, at 15mg/kg for a maximum single dose of 750mg given on days 0 and 7 for a total of up to 1500mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Screening Hepcidin and Change in Hemoglobin From Baseline to Highest Observed Hemoglobin Change (Proportion of Responders). | Responders were defined as subjects achieving an increase from baseline ≥2 g/dL at anytime between baseline and the end of the study (Day 28). The relation between screening hepcidin and change in hemoglobin was assessed with regression models with baseline hepcidin and treatment group as independent factors. Treatment group differences (oral vs. IV iron) for mean changes in endpoints were assessed with the analysis of covariance with a fixed factor for treatment and baseline value as covariate. Treatment group differences for proportions were assessed with the normal approximation to the binomial distribution. | anytime between baseline and end of study (day 28) or time of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Falone, MD | American Regent, Inc. | Study Director |
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This study was conducted at 41 study centers in the United States. The first subject was screened on 06 February 2014 and the last subject was completed on 07 July 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Injectafer | 2 doses of Injectafer, at 15 mg/kg for a maximum single dose of 750 mg given on Days 0 and 7 for a total of up to 1500 mg |
| FG001 | Ferrous Sulfate Tablets | Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Ferrous Sulfate tablets | Drug | 325mg (1 tablet) three times a day for 28 days |
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| COMPLETED |
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| NOT COMPLETED |
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Of the 198 subjects randomized, two subjects (one in each group) were not treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Injectafer | 2 doses of Injectafer, at 15 mg/kg for a maximum single dose of 750 mg given on Days 0 and 7 for a total of up to 1500 mg Injectafer: 2 doses of Injectafer, at 15mg/kg for a maximum single dose of 750mg given on days 0 and 7 for a total of up to 1500mg |
| BG001 | Ferrous Sulfate Tablets | Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days Ferrous Sulfate tablets: 325mg (1 tablet) three times a day for 28 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | The category of Race is Check All That Apply. In the Injectafer group, two subjects didn't check any options and one subject checked two options. In the Oral Iron group, one subject checked two options. | Number | participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Point of Care Hemoglobin | Included subjects who received at least 1 dose of randomized treatment and had at least 1 post-randomization measurement of hemoglobin | Mean | Standard Deviation | g/dL |
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| 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 | Correlation Between Screening Hepcidin and Change in Hemoglobin From Baseline to Highest Observed Hemoglobin Change (Proportion of Responders). | Responders were defined as subjects achieving an increase from baseline ≥2 g/dL at anytime between baseline and the end of the study (Day 28). The relation between screening hepcidin and change in hemoglobin was assessed with regression models with baseline hepcidin and treatment group as independent factors. Treatment group differences (oral vs. IV iron) for mean changes in endpoints were assessed with the analysis of covariance with a fixed factor for treatment and baseline value as covariate. Treatment group differences for proportions were assessed with the normal approximation to the binomial distribution. | Full analysis set population | Posted | Count of Participants | Participants | anytime between baseline and end of study (day 28) or time of intervention |
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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 of Injectafer, at 15 mg/kg for a maximum single dose of 750 mg given on Days 0 and 7 for a total of up to 1500 mg Injectafer: 2 doses of Injectafer, at 15mg/kg for a maximum single dose of 750mg given on days 0 and 7 for a total of up to 1500mg | 0 | 99 | 3 | 99 | 33 | 99 |
| EG001 | Ferrous Sulfate Tablets | Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days Ferrous Sulfate tablets: 325mg (1 tablet) three times a day for 28 days | 0 | 97 | 1 | 97 | 24 | 97 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
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| Crohn's disease | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
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| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Faeces discoulered | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Blood phosphorous decreased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
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The study was stopped early due to slow enrollment, however it was not considered prematurely terminated. A total of 198 of the 400 subjects planned were randomized, 196 were treated, and the study concluded normally.
Sponsor reserves the right to publish the results collected from all sites. PI may publish results from a specific site if there is no multi-site publication within 12 months of the conclusion, abandonment or termination of the study. PI must provide sponsor with copy of draft publication at least 60 days before the scheduled submission to allow sponsor to protect confidential information. PI must withhold submission of publication for 90 days to allow sponsor to seek patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angelia Butcher | Luitpold Pharmaceuticals, Inc. | 610-650-4200 | 811 | abutcher@lpicrd.com |
| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| D007505 | Iron-Dextran Complex |
| D007501 | Iron |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
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| Black/African American |
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| Asian |
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| American Indian/Alaska Native |
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