Trial Outcomes & Findings for Intravenous Ferric Carboxymaltose vs IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women (NCT NCT01290315)
NCT ID: NCT01290315
Last Updated: 2018-02-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Change from Baseline to Day 30
Results posted on
2018-02-08
Participant Flow
Hospitals and Medical Clinics. December 6, 2010 through October 13, 2012.
Discontinuation prior to dosing included lost to follow-up, subject request, and selection criteria/study compliance. A total of 19 subjects were excluded from the population of subjects evaluated for efficacy and safety-5 randomized to FCM 500mg, 2 randomized to FCM 750mg, 6 randomized to iron sucrose 500mg, and 6 randomized to iron dextran 750mg.
Participant milestones
| Measure |
Ferric Carboxymaltose (FCM) Cohort I
Intravenous iron
Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)
|
Iron Sucrose Cohort I
Intravenous iron
Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)
|
Ferric Carboxymaltose (FCM) Cohort II
Intravenous iron
Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)
|
Iron Dextran Cohort II
Intravenous iron
Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
10
|
13
|
|
Overall Study
COMPLETED
|
11
|
9
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
0
|
5
|
Reasons for withdrawal
| Measure |
Ferric Carboxymaltose (FCM) Cohort I
Intravenous iron
Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)
|
Iron Sucrose Cohort I
Intravenous iron
Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)
|
Ferric Carboxymaltose (FCM) Cohort II
Intravenous iron
Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)
|
Iron Dextran Cohort II
Intravenous iron
Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
3
|
|
Overall Study
Selection criteria/compliance
|
2
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Intravenous Ferric Carboxymaltose vs IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women
Baseline characteristics by cohort
| Measure |
Ferric Carboxymaltose (FCM) Cohort I
n=14 Participants
Intravenous iron
Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)
|
Iron Sucrose Cohort I
n=12 Participants
Intravenous iron
Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)
|
Ferric Carboxymaltose (FCM) Cohort II
n=10 Participants
Intravenous iron
Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)
|
Iron Dextran Cohort II
n=13 Participants
Intravenous iron
Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
32.1 years
STANDARD_DEVIATION 7.66 • n=5 Participants
|
29.6 years
STANDARD_DEVIATION 9.93 • n=7 Participants
|
39.2 years
STANDARD_DEVIATION 7.97 • n=5 Participants
|
39.2 years
STANDARD_DEVIATION 9.21 • n=4 Participants
|
34.8 years
STANDARD_DEVIATION 9.48 • n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
10 participants
n=5 Participants
|
13 participants
n=4 Participants
|
49 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Day 30Population: Only subjects with both a Baseline and at least one post-Baseline value are included.
Outcome measures
| Measure |
Ferric Carboxymaltose (FCM) Cohort I
n=12 Participants
Intravenous iron
Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)
|
Iron Sucrose Cohort I
n=9 Participants
Intravenous iron
Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)
|
Ferric Carboxymaltose (FCM) Cohort II
n=10 Participants
Intravenous iron
Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)
|
Iron Dextran Cohort II
n=10 Participants
Intravenous iron
Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)
|
|---|---|---|---|---|
|
Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
Carbonyl
|
-11.90 mg
Standard Deviation 52.55
|
-1.06 mg
Standard Deviation 38.722
|
-12.37 mg
Standard Deviation 32.91
|
-11.14 mg
Standard Deviation 48.57
|
|
Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
8-isoprostane
|
141.46 mg
Standard Deviation 892.16
|
-369.50 mg
Standard Deviation 957.06
|
8.83 mg
Standard Deviation 81.20
|
32.28 mg
Standard Deviation 233.41
|
PRIMARY outcome
Timeframe: Change from baseline to 2 hours post end IV infusionPopulation: Only subjects with both a baseline and at least one post baseline value are included.
Outcome measures
| Measure |
Ferric Carboxymaltose (FCM) Cohort I
n=12 Participants
Intravenous iron
Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)
|
Iron Sucrose Cohort I
n=10 Participants
Intravenous iron
Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)
|
Ferric Carboxymaltose (FCM) Cohort II
n=10 Participants
Intravenous iron
Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)
|
Iron Dextran Cohort II
n=11 Participants
Intravenous iron
Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)
|
|---|---|---|---|---|
|
Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
8-isoprostane
|
151.59 mg
Standard Deviation 833.75
|
-420.02 mg
Standard Deviation 803.52
|
-2.64 mg
Standard Deviation 30.44
|
-5.92 mg
Standard Deviation 216.66
|
|
Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
Carbonyl
|
2.07 mg
Standard Deviation 38.21
|
6.05 mg
Standard Deviation 24.69
|
-8.66 mg
Standard Deviation 43.15
|
-5.98 mg
Standard Deviation 23.71
|
PRIMARY outcome
Timeframe: Change from baseline to 24 hours post end IV infusionPopulation: Only subjects with both a baseline and at least one post baseline value are included.
Outcome measures
| Measure |
Ferric Carboxymaltose (FCM) Cohort I
n=12 Participants
Intravenous iron
Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)
|
Iron Sucrose Cohort I
n=10 Participants
Intravenous iron
Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)
|
Ferric Carboxymaltose (FCM) Cohort II
n=10 Participants
Intravenous iron
Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)
|
Iron Dextran Cohort II
n=11 Participants
Intravenous iron
Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)
|
|---|---|---|---|---|
|
Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
Carbonyl
|
8.63 mg
Standard Deviation 23.24
|
-6.92 mg
Standard Deviation 21.49
|
8.94 mg
Standard Deviation 87.05
|
-11.57 mg
Standard Deviation 40.30
|
|
Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
8-isoprostane
|
198.67 mg
Standard Deviation 864.29
|
119.26 mg
Standard Deviation 575.29
|
-23.96 mg
Standard Deviation 60.01
|
38.02 mg
Standard Deviation 190.07
|
PRIMARY outcome
Timeframe: Change from baseline to Day 7 post end IV infusionPopulation: Only subjects with both a baseline and at least one post baseline value are included.
Outcome measures
| Measure |
Ferric Carboxymaltose (FCM) Cohort I
n=10 Participants
Intravenous iron
Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)
|
Iron Sucrose Cohort I
n=8 Participants
Intravenous iron
Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)
|
Ferric Carboxymaltose (FCM) Cohort II
n=10 Participants
Intravenous iron
Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)
|
Iron Dextran Cohort II
n=9 Participants
Intravenous iron
Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)
|
|---|---|---|---|---|
|
Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
8-isoprostane
|
263.52 mg
Standard Deviation 896.57
|
-417.89 mg
Standard Deviation 1030.83
|
-29.35 mg
Standard Deviation 56.88
|
-58.04 mg
Standard Deviation 159.58
|
|
Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
Carbonyl
|
11.69 mg
Standard Deviation 36.43
|
-24.03 mg
Standard Deviation 65.55
|
-18.20 mg
Standard Deviation 45.92
|
-12.10 mg
Standard Deviation 54.85
|
Adverse Events
Ferric Carboxymaltose (FCM)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Iron Sucrose or Iron Dextran
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=24 participants at risk
Intravenous iron
Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II)
|
Iron Sucrose or Iron Dextran
n=25 participants at risk
Intravenous iron
Iron Sucrose / Iron Dextran: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I), or a 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)
|
|---|---|---|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/24 • 1 year and 10 months
|
8.0%
2/25 • Number of events 2 • 1 year and 10 months
|
Other adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=24 participants at risk
Intravenous iron
Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II)
|
Iron Sucrose or Iron Dextran
n=25 participants at risk
Intravenous iron
Iron Sucrose / Iron Dextran: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I), or a 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • Number of events 1 • 1 year and 10 months
|
8.0%
2/25 • Number of events 2 • 1 year and 10 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24 • 1 year and 10 months
|
4.0%
1/25 • Number of events 1 • 1 year and 10 months
|
|
General disorders
Injection site bruising
|
4.2%
1/24 • Number of events 1 • 1 year and 10 months
|
0.00%
0/25 • 1 year and 10 months
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/24 • 1 year and 10 months
|
8.0%
2/25 • Number of events 2 • 1 year and 10 months
|
|
Immune system disorders
Hypersensitivity
|
8.3%
2/24 • Number of events 2 • 1 year and 10 months
|
8.0%
2/25 • Number of events 2 • 1 year and 10 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.2%
1/24 • Number of events 1 • 1 year and 10 months
|
0.00%
0/25 • 1 year and 10 months
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • Number of events 1 • 1 year and 10 months
|
0.00%
0/25 • 1 year and 10 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/24 • 1 year and 10 months
|
8.0%
2/25 • Number of events 2 • 1 year and 10 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/24 • 1 year and 10 months
|
4.0%
1/25 • Number of events 1 • 1 year and 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60