Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02086968
Recruitment Status : Completed
First Posted : March 13, 2014
Results First Posted : September 17, 2020
Last Update Posted : September 17, 2020
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 Secondary to 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 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
Actual 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 (Proportion of Responders). [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for investigator information
Study Director: Mark A Falone, MD American Regent, Inc.
Layout table for additonal information
Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT02086968    
Other Study ID Numbers: 1VIT13035
First Posted: March 13, 2014    Key Record Dates
Results First Posted: September 17, 2020
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Inflammatory Bowel Diseases
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders