Trial Outcomes & Findings for Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA) (NCT NCT00982007)
NCT ID: NCT00982007
Last Updated: 2018-02-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
997 participants
Primary outcome timeframe
Day 35
Results posted on
2018-02-20
Participant Flow
Hospitals and Medical Clinics
Participant milestones
| Measure |
Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)
Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
|
Cohort 1 (Group B) - Ferrous Sulfate
Oral iron
Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day
|
Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)
Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
|
Cohort 2 (Group D) - IV Iron (Standard of Care)
Other IV iron
IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
250
|
257
|
253
|
251
|
|
Overall Study
COMPLETED
|
246
|
253
|
253
|
245
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
0
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)
Baseline characteristics by cohort
| Measure |
Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)
n=246 Participants
Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
|
Cohort 1 (Group B) - Ferrous Sulfate
n=253 Participants
Oral iron
Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day
|
Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)
n=253 Participants
Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
|
Cohort 2 (Group D) - IV Iron (Standard of Care)
n=245 Participants
Other IV iron IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion
|
Total
n=997 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
209 Participants
n=99 Participants
|
208 Participants
n=107 Participants
|
216 Participants
n=206 Participants
|
218 Participants
n=7 Participants
|
851 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
132 Participants
n=31 Participants
|
|
Age, Continuous
|
43.1 years
STANDARD_DEVIATION 17.18 • n=99 Participants
|
43.5 years
STANDARD_DEVIATION 17.71 • n=107 Participants
|
43.6 years
STANDARD_DEVIATION 16.88 • n=206 Participants
|
42.6 years
STANDARD_DEVIATION 15.51 • n=7 Participants
|
43.2 years
STANDARD_DEVIATION 16.63 • n=31 Participants
|
|
Sex: Female, Male
Female
|
233 Participants
n=99 Participants
|
238 Participants
n=107 Participants
|
239 Participants
n=206 Participants
|
231 Participants
n=7 Participants
|
941 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
56 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
246 participants
n=99 Participants
|
253 participants
n=107 Participants
|
253 participants
n=206 Participants
|
245 participants
n=7 Participants
|
997 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Day 35Population: Modified Intent-to-Treat Population: Subjects who have received at least 1 dose of randomized study medication and had at least 1 post-baseline hemoglobin assessment
Outcome measures
| Measure |
Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)
n=244 Participants
Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
|
Cohort 1 (Group B) - Ferrous Sulfate
n=251 Participants
Oral iron
Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day
|
Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)
n=245 Participants
Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
|
Cohort 2 (Group D) - IV Iron (Standard of Care)
n=237 Participants
Other IV iron
IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion
|
|---|---|---|---|---|
|
Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.
|
1.57 g/dL
Standard Deviation 1.194
|
0.80 g/dL
Standard Deviation 0.799
|
2.90 g/dL
Standard Deviation 1.640
|
2.16 g/dL
Standard Deviation 1.252
|
Adverse Events
Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)
Serious events: 8 serious events
Other events: 31 other events
Deaths: 0 deaths
Cohort 1 (Group B) - Ferrous Sulfate
Serious events: 10 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)
Serious events: 17 serious events
Other events: 26 other events
Deaths: 0 deaths
Cohort 2 (Group D) - IV Iron (Standard of Care)
Serious events: 16 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)
n=246 participants at risk
Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
|
Cohort 1 (Group B) - Ferrous Sulfate
n=253 participants at risk
Oral iron
Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day
|
Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)
n=253 participants at risk
Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
|
Cohort 2 (Group D) - IV Iron (Standard of Care)
n=245 participants at risk
Other IV iron
IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.41%
1/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.79%
2/253 • 1 year and 6 months
|
0.41%
1/245 • 1 year and 6 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/246 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/246 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Congenital, familial and genetic disorders
Cystic fibrosis
|
0.41%
1/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.41%
1/245 • 1 year and 6 months
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.41%
1/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.41%
1/245 • 1 year and 6 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Gastrointestinal disorders
Volvulus
|
0.41%
1/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
General disorders
Chest pain
|
0.00%
0/246 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
General disorders
Death
|
0.00%
0/246 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
General disorders
Fatigue
|
0.41%
1/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/246 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.41%
1/245 • 1 year and 6 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
1.2%
3/245 • 1 year and 6 months
|
|
Infections and infestations
Bacteremia
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.41%
1/245 • 1 year and 6 months
|
|
Infections and infestations
Mastitis
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Infections and infestations
Pneumonia
|
0.41%
1/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Infections and infestations
Septic shock
|
0.00%
0/246 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.41%
1/245 • 1 year and 6 months
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/246 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.41%
1/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.41%
1/245 • 1 year and 6 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/246 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.41%
1/245 • 1 year and 6 months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/246 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.41%
1/245 • 1 year and 6 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/246 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/246 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.41%
1/245 • 1 year and 6 months
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.41%
1/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.79%
2/253 • 1 year and 6 months
|
0.82%
2/245 • 1 year and 6 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.41%
1/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
|
Reproductive system and breast disorders
Uterine disorder
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.41%
1/245 • 1 year and 6 months
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
0.00%
0/246 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.41%
1/245 • 1 year and 6 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.41%
1/245 • 1 year and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.41%
1/245 • 1 year and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
0.40%
1/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
Other adverse events
| Measure |
Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)
n=246 participants at risk
Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
|
Cohort 1 (Group B) - Ferrous Sulfate
n=253 participants at risk
Oral iron
Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day
|
Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)
n=253 participants at risk
Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
|
Cohort 2 (Group D) - IV Iron (Standard of Care)
n=245 participants at risk
Other IV iron
IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.1%
20/246 • 1 year and 6 months
|
2.0%
5/253 • 1 year and 6 months
|
4.0%
10/253 • 1 year and 6 months
|
4.1%
10/245 • 1 year and 6 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.5%
11/246 • 1 year and 6 months
|
0.00%
0/253 • 1 year and 6 months
|
6.3%
16/253 • 1 year and 6 months
|
0.00%
0/245 • 1 year and 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60