Trial Outcomes & Findings for Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia (NCT NCT00704353)
NCT ID: NCT00704353
Last Updated: 2018-02-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
735 participants
Primary outcome timeframe
through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)
Results posted on
2018-02-20
Participant Flow
Hospitals and medical clinics
Participant milestones
| Measure |
Ferric Carboxymaltose (FCM)
Subjects receieved an undiluted dose of iron as FCM (15mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
|
Standard Medical Care
Subjects received standard medical care (as determined by the Investigator) for treatment of IDA.
|
|---|---|---|
|
Overall Study
STARTED
|
366
|
369
|
|
Overall Study
COMPLETED
|
268
|
255
|
|
Overall Study
NOT COMPLETED
|
98
|
114
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia
Baseline characteristics by cohort
| Measure |
Ferric Carboxymaltose (FCM)
n=366 Participants
Subjects receieved an undiluted dose of iron as FCM (15mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
|
Standard Medical Care
n=369 Participants
Subjects received standard medical care (as determined by the Investigator) for treatment of IDA.
|
Total
n=735 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
266 Participants
n=99 Participants
|
265 Participants
n=107 Participants
|
531 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
97 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
195 Participants
n=206 Participants
|
|
Age, Continuous
|
49.2 years
STANDARD_DEVIATION 19.94 • n=99 Participants
|
49.6 years
STANDARD_DEVIATION 19.88 • n=107 Participants
|
49.4 years
STANDARD_DEVIATION 19.91 • n=206 Participants
|
|
Sex: Female, Male
Female
|
322 Participants
n=99 Participants
|
315 Participants
n=107 Participants
|
637 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
366 participants
n=99 Participants
|
369 participants
n=107 Participants
|
735 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)Outcome measures
| Measure |
Ferric Carboxymaltose (FCM)
n=366 Participants
Subjects received an undiluted dose of iron as FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
|
Standard Medical Care
n=369 Participants
Received standard medical care (as determined by the Investigator) of IDA.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Serious Adverse Events (SAE's)
|
5 participants
|
9 participants
|
Adverse Events
Ferric Carboxymaltose (FCM)
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Medical Care
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=366 participants at risk
Subjects received an undiluted dose of iron as FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
|
Standard Medical Care
n=369 participants at risk
Received standard medical care (as determined by the Investigator) of IDA.
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
0.27%
1/366 • 1 year
|
0.00%
0/369 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.27%
1/366 • 1 year
|
0.00%
0/369 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/366 • 1 year
|
0.27%
1/369 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.27%
1/366 • 1 year
|
0.00%
0/369 • 1 year
|
|
Cardiac disorders
Cardiomyopathy
|
0.27%
1/366 • 1 year
|
0.00%
0/369 • 1 year
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/366 • 1 year
|
0.27%
1/369 • 1 year
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/366 • 1 year
|
0.27%
1/369 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.27%
1/366 • 1 year
|
0.00%
0/369 • 1 year
|
|
General disorders
Pyrexia
|
0.00%
0/366 • 1 year
|
0.27%
1/369 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.00%
0/366 • 1 year
|
0.54%
2/369 • 1 year
|
|
Injury, poisoning and procedural complications
Inappropriate device stimulation of tissue
|
0.27%
1/366 • 1 year
|
0.00%
0/369 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.27%
1/366 • 1 year
|
0.00%
0/369 • 1 year
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/366 • 1 year
|
0.27%
1/369 • 1 year
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/366 • 1 year
|
0.27%
1/369 • 1 year
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/366 • 1 year
|
0.27%
1/369 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.27%
1/366 • 1 year
|
0.00%
0/369 • 1 year
|
|
Vascular disorders
Hypertension
|
0.00%
0/366 • 1 year
|
0.27%
1/369 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60