Phase 4
Completed N=198
Treatment Response of Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass
Iron Deficiency Anemia Secondary to IBD or Gastric Bypass
Source: ClinicalTrials.gov NCT02086968 ↗
Enrolled (actual)
198
Serious AEs
2.0%
Results posted
Sep 2020
Primary outcomePrimary: Correlation Between Screening Hepcidin and Change in Hemoglobin From Baseline to Highest Observed Hemoglobin Change (Proportion of Responders). — 60; 34 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between Screening Hepcidin and Change in Hemoglobin From Baseline to Highest Observed Hemoglobin Change (Proportion of Responders). |
60; 34 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02086968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.