Overview

This trial is active, not recruiting.

Condition iron deficiency anemia (ida) secondary to inflammatory bowel disease (ibd) or gastric bypass
Treatments injectafer, ferrous sulfate tablets
Phase phase 4
Sponsor Luitpold Pharmaceuticals
Start date January 2014
End date October 2016
Trial size 186 participants
Trial identifier NCT02086968, 1VIT13035

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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
injectafer Ferric Carboxymaltose (FCM)
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
(Active Comparator)
Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days
ferrous sulfate tablets Oral Iron tablets
325mg (1 tablet) three times a day for 28 days

Primary Outcomes

Measure
Correlation between screening hepcidin and change in hemoglobin from baseline to highest observed hemoglobin change.
time frame: anytime between baseline and end of study (day 28) or time of intervention

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Multi-center, Randomized, Open-label, Controlled Study to Investigate the Treatment Response of Intravenous Injectafer vs. Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Luitpold Pharmaceuticals.