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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

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ClinicalTrials.gov Identifier: NCT02086968
Recruitment Status : Unknown
Verified March 2017 by American Regent, Inc..
Recruitment status was:  Active, not recruiting
First Posted : March 13, 2014
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
American Regent, Inc.

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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass Drug: Injectafer Drug: Ferrous Sulfate tablets Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : July 16, 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Active Comparator: 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
Drug: 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
Other Name: Ferric Carboxymaltose (FCM)

Active Comparator: Ferrous Sulfate tablets
Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days
Drug: Ferrous Sulfate tablets
325mg (1 tablet) three times a day for 28 days
Other Name: Oral Iron tablets




Primary Outcome Measures :
  1. 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 ]
    The primary endpoint is the correlation between screening hepcidin and change in hemoglobin from baseline to highest observed hemoglobin change.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086968


Sponsors and Collaborators
American Regent, Inc.
Investigators
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Study Director: Sumita Chowdhury, MD American Regent, Inc.

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Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT02086968    
Other Study ID Numbers: 1VIT13035
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Intestinal Diseases
Inflammatory Bowel Diseases
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Hepcidins
Ferric Compounds
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anti-Infective Agents
Hematinics