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

• 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: American Regent, Inc.
• Information provided by (Responsible Party): American Regent, Inc.

Tracking Information

• First Submitted Date: March 12, 2014
• First Posted Date: March 13, 2014
• Results First Submitted Date: December 11, 2017
• Results First Posted Date: September 17, 2020
• Last Update Posted Date: September 17, 2020
• Actual Study Start Date: January 1, 2014
• Actual Primary Completion Date: July 16, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 16, 2020)

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.

Original Primary Outcome Measures (submitted: March 12, 2014)

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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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
• 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Iron Deficiency Anemia Secondary to IBD or Gastric Bypass

Intervention

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

Study Arms

• 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
  Intervention: Drug: Injectafer
• Active Comparator: Ferrous Sulfate tablets
  Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days
  Intervention: Drug: Ferrous Sulfate tablets

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 16, 2020): 198
• Original Estimated Enrollment (submitted: March 12, 2014): 400
• Actual Study Completion Date: October 2017
• Actual Primary Completion Date: July 16, 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT02086968
• Other Study ID Numbers: 1VIT13035
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: American Regent, Inc.
• Study Sponsor: American Regent, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Mark A Falone, MD; American Regent, Inc.

• PRS Account: American Regent, Inc.
• Verification Date: September 2020