Working…
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.

Study Type Interventional
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
Interventions Drug: Injectafer
Drug: Ferrous Sulfate tablets
Enrollment 198
Recruitment Details This study was conducted at 41 study centers in the United States. The first subject was screened on 06 February 2014 and the last subject was completed on 07 July 2016.
Pre-assignment Details  
Arm/Group Title Injectafer Ferrous Sulfate Tablets
Hide Arm/Group Description 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 Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days
Period Title: Overall Study
Started 100 98
Completed 92 85
Not Completed 8 13
Reason Not Completed
Adverse Event             1             5
Lost to Follow-up             2             3
Study drug received outside protocol             0             1
Physician Decision             4             0
Withdrawal by Subject             1             4
Arm/Group Title Injectafer Ferrous Sulfate Tablets Total
Hide Arm/Group Description

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: 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

Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days

Ferrous Sulfate tablets: 325mg (1 tablet) three times a day for 28 days

Total of all reporting groups
Overall Number of Baseline Participants 99 97 196
Hide Baseline Analysis Population Description
Of the 198 subjects randomized, two subjects (one in each group) were not treated.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 99 participants 97 participants 196 participants
38.3
(18.6 to 85.5)
43.0
(18.5 to 74.3)
40.5
(18.5 to 85.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 97 participants 196 participants
Female
76
  76.8%
66
  68.0%
142
  72.4%
Male
23
  23.2%
31
  32.0%
54
  27.6%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 97 participants 97 participants 194 participants
72 79 151
Black/African American Number Analyzed 97 participants 97 participants 194 participants
25 17 42
Asian Number Analyzed 97 participants 97 participants 194 participants
1 1 2
American Indian/Alaska Native Number Analyzed 97 participants 97 participants 194 participants
0 1 1
[1]
Measure Analysis Population Description: The category of Race is Check All That Apply. In the Injectafer group, two subjects didn't check any options and one subject checked two options. In the Oral Iron group, one subject checked two options.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 99 participants 97 participants 196 participants
99
 100.0%
97
 100.0%
196
 100.0%
Point of Care Hemoglobin   [1] 
Mean (Standard Deviation)
Unit of measure:  g/dL
Number Analyzed 99 participants 95 participants 194 participants
9.3  (1.19) 9.4  (0.99) 9.3  (1.10)
[1]
Measure Analysis Population Description: Included subjects who received at least 1 dose of randomized treatment and had at least 1 post-randomization measurement of hemoglobin
1.Primary Outcome
Title Correlation Between Screening Hepcidin and Change in Hemoglobin From Baseline to Highest Observed Hemoglobin Change (Proportion of Responders).
Hide Description 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.
Time Frame anytime between baseline and end of study (day 28) or time of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set population
Arm/Group Title Injectafer Ferrous Sulfate Tablets
Hide Arm/Group Description:

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: 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

Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days

Ferrous Sulfate tablets: 325mg (1 tablet) three times a day for 28 days

Overall Number of Participants Analyzed 94 92
Measure Type: Count of Participants
Unit of Measure: Participants
60
  63.8%
34
  37.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Injectafer Ferrous Sulfate Tablets
Hide Arm/Group Description

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: 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

Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days

Ferrous Sulfate tablets: 325mg (1 tablet) three times a day for 28 days

All-Cause Mortality
Injectafer Ferrous Sulfate Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   0/99 (0.00%)      0/97 (0.00%)    
Hide Serious Adverse Events
Injectafer Ferrous Sulfate Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/99 (3.03%)      1/97 (1.03%)    
Gastrointestinal disorders     
Colitis ulcerative  1  1/99 (1.01%)  1 0/97 (0.00%)  0
Crohn's disease  1  0/99 (0.00%)  0 1/97 (1.03%)  1
Large intestinal obstruction  1  1/99 (1.01%)  1 0/97 (0.00%)  0
Small intestinal obstruction  1  0/99 (0.00%)  0 1/97 (1.03%)  1
Infections and infestations     
Clostridium difficile colitis  1  1/99 (1.01%)  1 0/97 (0.00%)  0
1
Term from vocabulary, MedDRA (16.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Injectafer Ferrous Sulfate Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/99 (33.33%)      24/97 (24.74%)    
Gastrointestinal disorders     
Abdominal pain * 1  1/99 (1.01%)  1 5/97 (5.15%)  5
Abdominal pain upper * 1  0/99 (0.00%)  0 3/97 (3.09%)  3
Constipation * 1  1/99 (1.01%)  1 10/97 (10.31%)  10
Diarrhoea * 1  0/99 (0.00%)  0 3/97 (3.09%)  3
Dyspepsia * 1  2/99 (2.02%)  2 0/97 (0.00%)  0
Faeces discoulered * 1  0/99 (0.00%)  0 3/97 (3.09%)  3
Flatulence * 1  0/99 (0.00%)  0 2/97 (2.06%)  2
Nausea * 1  2/99 (2.02%)  2 6/97 (6.19%)  6
Rectal haemorrhage * 1  0/99 (0.00%)  0 2/97 (2.06%)  2
Vomiting * 1  0/99 (0.00%)  0 5/97 (5.15%)  5
Immune system disorders     
Hypersensitivity * 1  2/99 (2.02%)  2 0/97 (0.00%)  0
Investigations     
Blood phosphorous decreased * 1  10/99 (10.10%)  10 0/97 (0.00%)  0
Metabolism and nutrition disorders     
Hypophosphataemia * 1  5/99 (5.05%)  5 0/97 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain * 1  2/99 (2.02%)  2 0/97 (0.00%)  0
Nervous system disorders     
Headache * 1  4/99 (4.04%)  4 0/97 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus * 1  3/99 (3.03%)  3 0/97 (0.00%)  0
Urticaria * 1  2/99 (2.02%)  2 0/97 (0.00%)  0
1
Term from vocabulary, MedDRA (16.1)
*
Indicates events were collected by non-systematic assessment
The study was stopped early due to slow enrollment, however it was not considered prematurely terminated. A total of 198 of the 400 subjects planned were randomized, 196 were treated, and the study concluded normally.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right to publish the results collected from all sites. PI may publish results from a specific site if there is no multi-site publication within 12 months of the conclusion, abandonment or termination of the study. PI must provide sponsor with copy of draft publication at least 60 days before the scheduled submission to allow sponsor to protect confidential information. PI must withhold submission of publication for 90 days to allow sponsor to seek patent protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Angelia Butcher
Organization: Luitpold Pharmaceuticals, Inc.
Phone: 610-650-4200 ext 811
EMail: abutcher@lpicrd.com
Layout table for additonal information
Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT02086968    
Other Study ID Numbers: 1VIT13035
First Submitted: March 12, 2014
First Posted: March 13, 2014
Results First Submitted: December 11, 2017
Results First Posted: September 17, 2020
Last Update Posted: September 17, 2020