Iron Deficiency Anemia Secondary to IBD or Gastric Bypass Clinical Trial
Official title:
Multicenter Randomized Open-label Controlled Study to Investigate Treatment Response of IV Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia Secondary to Inflammatory Bowel Disease or Gastric Bypass
| Verified date | September 2020 |
| Source | American Regent, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 198 |
| Est. completion date | October 2017 |
| Est. primary completion date | July 16, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| American Regent, Inc. |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | anytime between baseline and end of study (day 28) or time of intervention |