Trial Outcomes & Findings for Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia (NCT NCT00704028)
NCT ID: NCT00704028
Last Updated: 2018-02-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
161 participants
Primary outcome timeframe
Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longer
Results posted on
2018-02-20
Participant Flow
Hospitals and medical clinics
One subject randomized to iron dextran never received study drug and was discontinued due to subject request.
Participant milestones
| Measure |
Ferric Carboxymaltose (FCM)
15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
|
Iron Dextran
As determined by the investigator to a maximum cumulative dose of 2,250 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
78
|
|
Overall Study
COMPLETED
|
70
|
57
|
|
Overall Study
NOT COMPLETED
|
12
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia
Baseline characteristics by cohort
| Measure |
Ferric Carboxymaltose (FCM)
n=82 Participants
15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
|
Iron Dextran
n=78 Participants
As determined by the investigator to a maximum cumulative dose of 2,250 mg.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
72 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 14.64 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 17.10 • n=7 Participants
|
47.2 years
STANDARD_DEVIATION 15.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=5 Participants
|
78 participants
n=7 Participants
|
160 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longerOutcome measures
| Measure |
Ferric Carboxymaltose (FCM)
n=82 Participants
15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
|
Iron Dextran
n=78 Participants
As determined by the investigator to a maximum cumulative dose of 2,250 mg.
|
|---|---|---|
|
The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's)
|
60 participants
|
59 participants
|
Adverse Events
Ferric Carboxymaltose (FCM)
Serious events: 5 serious events
Other events: 45 other events
Deaths: 0 deaths
Iron Dextran
Serious events: 3 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=82 participants at risk
15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
|
Iron Dextran
n=78 participants at risk
As determined by the investigator to a maximum cumulative dose of 2,250 mg.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/82 • 1 year
|
1.3%
1/78 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/82 • 1 year
|
0.00%
0/78 • 1 year
|
|
Gastrointestinal disorders
Crohn's disease
|
1.2%
1/82 • 1 year
|
0.00%
0/78 • 1 year
|
|
General disorders
Asthenia
|
1.2%
1/82 • 1 year
|
0.00%
0/78 • 1 year
|
|
General disorders
Death
|
1.2%
1/82 • 1 year
|
0.00%
0/78 • 1 year
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/82 • 1 year
|
1.3%
1/78 • 1 year
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/82 • 1 year
|
1.3%
1/78 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer recurrent
|
1.2%
1/82 • 1 year
|
0.00%
0/78 • 1 year
|
|
Nervous system disorders
Syncope
|
2.4%
2/82 • 1 year
|
0.00%
0/78 • 1 year
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.00%
0/82 • 1 year
|
1.3%
1/78 • 1 year
|
Other adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=82 participants at risk
15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
|
Iron Dextran
n=78 participants at risk
As determined by the investigator to a maximum cumulative dose of 2,250 mg.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
6.1%
5/82 • 1 year
|
3.8%
3/78 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
14.6%
12/82 • 1 year
|
10.3%
8/78 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
5/82 • 1 year
|
5.1%
4/78 • 1 year
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/82 • 1 year
|
9.0%
7/78 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.5%
7/82 • 1 year
|
0.00%
0/78 • 1 year
|
|
Nervous system disorders
Dizziness
|
7.3%
6/82 • 1 year
|
5.1%
4/78 • 1 year
|
|
Nervous system disorders
Headache
|
7.3%
6/82 • 1 year
|
12.8%
10/78 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
2/82 • 1 year
|
7.7%
6/78 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
2/82 • 1 year
|
6.4%
5/78 • 1 year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/82 • 1 year
|
9.0%
7/78 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60