Trial Outcomes & Findings for Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia (NCT NCT00703937)
NCT ID: NCT00703937
Last Updated: 2018-02-20
Results Overview
Safety, as defined by the occurence of serious adverse events (SAE's), of FCM compared to SMC in the treatment of IDA in subjects who were not dialysis dependent
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
708 participants
Primary outcome timeframe
First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer
Results posted on
2018-02-20
Participant Flow
Hospitals and medical clinics
5 subjects randomized into the trial were discontinued prior to dosing.
Participant milestones
| Measure |
Ferric Carboxymaltose (FCM)
750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
|
Standard Medical Care (SMC) for the Treatment of IDA
SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
|
|---|---|---|
|
Overall Study
STARTED
|
343
|
360
|
|
Overall Study
COMPLETED
|
278
|
267
|
|
Overall Study
NOT COMPLETED
|
65
|
93
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia
Baseline characteristics by cohort
| Measure |
Ferric Carboxymaltose (FCM)
n=343 Participants
750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
|
Standard Medical Care (SMC) for the Treatment of IDA
n=360 Participants
SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
|
Total
n=703 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
267 Participants
n=5 Participants
|
287 Participants
n=7 Participants
|
554 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
75 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 18.48 • n=5 Participants
|
47.7 years
STANDARD_DEVIATION 17.62 • n=7 Participants
|
48.5 years
STANDARD_DEVIATION 18.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
292 Participants
n=5 Participants
|
318 Participants
n=7 Participants
|
610 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
343 participants
n=5 Participants
|
360 participants
n=7 Participants
|
703 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longerSafety, as defined by the occurence of serious adverse events (SAE's), of FCM compared to SMC in the treatment of IDA in subjects who were not dialysis dependent
Outcome measures
| Measure |
Ferric Carboxymaltose (FCM)
n=343 Participants
750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
|
Standard Medical Care (SMC) for the Treatment of IDA
n=360 Participants
SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
|
|---|---|---|
|
Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC
|
17 participants
|
11 participants
|
Adverse Events
Ferric Carboxymaltose (FCM)
Serious events: 17 serious events
Other events: 41 other events
Deaths: 0 deaths
Standard Medical Care (SMC) for the Treatment of IDA
Serious events: 11 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=343 participants at risk
750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
|
Standard Medical Care (SMC) for the Treatment of IDA
n=360 participants at risk
SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.29%
1/343 • 1 year
|
0.56%
2/360 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.29%
1/343 • 1 year
|
0.00%
0/360 • 1 year
|
|
Cardiac disorders
Coronary artery disease
|
0.29%
1/343 • 1 year
|
0.00%
0/360 • 1 year
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/343 • 1 year
|
0.28%
1/360 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.29%
1/343 • 1 year
|
0.00%
0/360 • 1 year
|
|
Gastrointestinal disorders
Ascites
|
0.29%
1/343 • 1 year
|
0.00%
0/360 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.29%
1/343 • 1 year
|
0.00%
0/360 • 1 year
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/343 • 1 year
|
0.28%
1/360 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.58%
2/343 • 1 year
|
0.28%
1/360 • 1 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.29%
1/343 • 1 year
|
0.00%
0/360 • 1 year
|
|
General disorders
Chest pain
|
0.00%
0/343 • 1 year
|
0.28%
1/360 • 1 year
|
|
Infections and infestations
Cellulitis
|
0.00%
0/343 • 1 year
|
0.28%
1/360 • 1 year
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.29%
1/343 • 1 year
|
0.00%
0/360 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.29%
1/343 • 1 year
|
0.00%
0/360 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.29%
1/343 • 1 year
|
0.00%
0/360 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/343 • 1 year
|
0.28%
1/360 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.29%
1/343 • 1 year
|
0.00%
0/360 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.29%
1/343 • 1 year
|
0.00%
0/360 • 1 year
|
|
Nervous system disorders
Cartoid artery stenosis
|
0.29%
1/343 • 1 year
|
0.00%
0/360 • 1 year
|
|
Nervous system disorders
Facial palsy
|
0.29%
1/343 • 1 year
|
0.00%
0/360 • 1 year
|
|
Renal and urinary disorders
Renal failure acute
|
0.29%
1/343 • 1 year
|
0.00%
0/360 • 1 year
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/343 • 1 year
|
0.28%
1/360 • 1 year
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/343 • 1 year
|
0.56%
2/360 • 1 year
|
|
Vascular disorders
Hypertensive crisis
|
0.29%
1/343 • 1 year
|
0.00%
0/360 • 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/343 • 1 year
|
0.28%
1/360 • 1 year
|
Other adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=343 participants at risk
750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
|
Standard Medical Care (SMC) for the Treatment of IDA
n=360 participants at risk
SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
3.5%
12/343 • 1 year
|
7.2%
26/360 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
4.1%
14/343 • 1 year
|
7.5%
27/360 • 1 year
|
|
Nervous system disorders
Headache
|
4.7%
16/343 • 1 year
|
5.0%
18/360 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60