Trial Outcomes & Findings for 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 (NCT NCT02086968)
NCT ID: NCT02086968
Last Updated: 2020-09-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
198 participants
Primary outcome timeframe
anytime between baseline and end of study (day 28) or time of intervention
Results posted on
2020-09-17
Participant Flow
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.
Participant milestones
| Measure |
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
|
Ferrous Sulfate Tablets
Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
98
|
|
Overall Study
COMPLETED
|
92
|
85
|
|
Overall Study
NOT COMPLETED
|
8
|
13
|
Reasons for withdrawal
| Measure |
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
|
Ferrous Sulfate Tablets
Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Study drug received outside protocol
|
0
|
1
|
|
Overall Study
Physician Decision
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Injectafer
n=99 Participants
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
|
Ferrous Sulfate Tablets
n=97 Participants
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
n=196 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.3 years
n=99 Participants
|
43.0 years
n=97 Participants
|
40.5 years
n=196 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=99 Participants
|
66 Participants
n=97 Participants
|
142 Participants
n=196 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
31 Participants
n=97 Participants
|
54 Participants
n=196 Participants
|
|
Race/Ethnicity, Customized
White
|
72 participants
n=97 Participants • 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.
|
79 participants
n=97 Participants • 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.
|
151 participants
n=194 Participants • 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.
|
|
Race/Ethnicity, Customized
Black/African American
|
25 participants
n=97 Participants • 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.
|
17 participants
n=97 Participants • 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.
|
42 participants
n=194 Participants • 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.
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=97 Participants • 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.
|
1 participants
n=97 Participants • 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.
|
2 participants
n=194 Participants • 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.
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 participants
n=97 Participants • 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.
|
1 participants
n=97 Participants • 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.
|
1 participants
n=194 Participants • 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
United States
|
99 Participants
n=99 Participants
|
97 Participants
n=97 Participants
|
196 Participants
n=196 Participants
|
|
Point of Care Hemoglobin
|
9.3 g/dL
STANDARD_DEVIATION 1.19 • n=99 Participants • Included subjects who received at least 1 dose of randomized treatment and had at least 1 post-randomization measurement of hemoglobin
|
9.4 g/dL
STANDARD_DEVIATION 0.99 • n=95 Participants • Included subjects who received at least 1 dose of randomized treatment and had at least 1 post-randomization measurement of hemoglobin
|
9.3 g/dL
STANDARD_DEVIATION 1.10 • n=194 Participants • Included subjects who received at least 1 dose of randomized treatment and had at least 1 post-randomization measurement of hemoglobin
|
PRIMARY outcome
Timeframe: anytime between baseline and end of study (day 28) or time of interventionPopulation: Full analysis set population
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.
Outcome measures
| Measure |
Injectafer
n=94 Participants
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
|
Ferrous Sulfate Tablets
n=92 Participants
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
|
|---|---|---|
|
Correlation Between Screening Hepcidin and Change in Hemoglobin From Baseline to Highest Observed Hemoglobin Change (Proportion of Responders).
|
60 Participants
|
34 Participants
|
Adverse Events
Injectafer
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
Ferrous Sulfate Tablets
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Injectafer
n=99 participants at risk
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
|
Ferrous Sulfate Tablets
n=97 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.0%
1/99 • Number of events 1
|
0.00%
0/97
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/99
|
1.0%
1/97 • Number of events 1
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
1.0%
1/99 • Number of events 1
|
0.00%
0/97
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/99
|
1.0%
1/97 • Number of events 1
|
|
Infections and infestations
Clostridium difficile colitis
|
1.0%
1/99 • Number of events 1
|
0.00%
0/97
|
Other adverse events
| Measure |
Injectafer
n=99 participants at risk
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
|
Ferrous Sulfate Tablets
n=97 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/99 • Number of events 1
|
5.2%
5/97 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/99
|
3.1%
3/97 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
1.0%
1/99 • Number of events 1
|
10.3%
10/97 • Number of events 10
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/99
|
3.1%
3/97 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
2/99 • Number of events 2
|
0.00%
0/97
|
|
Gastrointestinal disorders
Faeces discoulered
|
0.00%
0/99
|
3.1%
3/97 • Number of events 3
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/99
|
2.1%
2/97 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
2.0%
2/99 • Number of events 2
|
6.2%
6/97 • Number of events 6
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/99
|
2.1%
2/97 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/99
|
5.2%
5/97 • Number of events 5
|
|
Immune system disorders
Hypersensitivity
|
2.0%
2/99 • Number of events 2
|
0.00%
0/97
|
|
Investigations
Blood phosphorous decreased
|
10.1%
10/99 • Number of events 10
|
0.00%
0/97
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.1%
5/99 • Number of events 5
|
0.00%
0/97
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.0%
2/99 • Number of events 2
|
0.00%
0/97
|
|
Nervous system disorders
Headache
|
4.0%
4/99 • Number of events 4
|
0.00%
0/97
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.0%
3/99 • Number of events 3
|
0.00%
0/97
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.0%
2/99 • Number of events 2
|
0.00%
0/97
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER