Iron Deficiency Anemia Secondary to IBD or Gastric Bypass
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGInjectafer
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
325mg (1 tablet) three times a day for 28 days
Sponsors
American Regent, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Male or female subjects ≥ 18 years of age with clinical diagnosis of IDA secondary to IBD or Gastric Bypass * Screening Hemoglobin (Hb) ≤ 11g/dL * Screening Ferritin ≤ 100 ng/mL * 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
Exclusion criteria
* Hypersensitivity reaction to any component of IV Injectafer or oral iron * Requires dialysis for treatment of chronic kidney disease (CKD) * During the 30 day period prior to screening has been treated with IV iron * No evidence of iron deficiency * During the 30 day period prior to screening has been treated with a red blood cell transfusion. * Any non-viral infection * Known positive hepatitis with evidence of active disease * Received an investigational drug within 30 days of screening * Active malignancy within 5 years. Basal or squamous cell skin cancer is not exclusionary * Alcohol or drug abuse within the past 6 months * Hemochromatosis or other iron storage disorders * Pregnant * 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 the study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Screening Hepcidin and Change in Hemoglobin From Baseline to Highest Observed Hemoglobin Change (Proportion of Responders). | anytime between baseline and end of study (day 28) or time of intervention | 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. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 99 |
| 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 | 97 |
| Total | 196 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 5 |
| Overall Study | Lost to Follow-up | 2 | 3 |
| Overall Study | Physician Decision | 4 | 0 |
| Overall Study | Study drug received outside protocol | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | Injectafer | Ferrous Sulfate Tablets | Total |
|---|---|---|---|
| Age, Continuous | 38.3 years | 43.0 years | 40.5 years |
| Point of Care Hemoglobin | 9.3 g/dL STANDARD_DEVIATION 1.19 | 9.4 g/dL STANDARD_DEVIATION 0.99 | 9.3 g/dL STANDARD_DEVIATION 1.1 |
| Race/Ethnicity, Customized American Indian/Alaska Native | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Black/African American | 25 participants | 17 participants | 42 participants |
| Race/Ethnicity, Customized White | 72 participants | 79 participants | 151 participants |
| Region of Enrollment United States | 99 Participants | 97 Participants | 196 Participants |
| Sex: Female, Male Female | 76 Participants | 66 Participants | 142 Participants |
| Sex: Female, Male Male | 23 Participants | 31 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 97 |
| other Total, other adverse events | 33 / 99 | 24 / 97 |
| serious Total, serious adverse events | 3 / 99 | 1 / 97 |
Outcome results
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.
Time frame: anytime between baseline and end of study (day 28) or time of intervention
Population: Full analysis set population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Injectafer | Correlation Between Screening Hepcidin and Change in Hemoglobin From Baseline to Highest Observed Hemoglobin Change (Proportion of Responders). | 60 Participants |
| Ferrous Sulfate Tablets | Correlation Between Screening Hepcidin and Change in Hemoglobin From Baseline to Highest Observed Hemoglobin Change (Proportion of Responders). | 34 Participants |