Trial Outcomes & Findings for Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients (NCT NCT00548691)
NCT ID: NCT00548691
Last Updated: 2018-02-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
513 participants
Primary outcome timeframe
from Day 0 through 30 days after the last dose of study drug
Results posted on
2018-02-20
Participant Flow
Hospitals and medical clinics
Participant milestones
| Measure |
Ferric Carboxymaltose (FCM)
Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
|
Standard Medical Care (SMC)
SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
|
|---|---|---|
|
Overall Study
STARTED
|
258
|
259
|
|
Overall Study
COMPLETED
|
251
|
250
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients
Baseline characteristics by cohort
| Measure |
Ferric Carboxymaltose (FCM)
n=254 Participants
Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
|
Standard Medical Care (SMC)
n=259 Participants
SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
|
Total
n=513 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
|
|
Age, Categorical
Between 18 and 65 years
|
127 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
127 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 12.81 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 12.11 • n=7 Participants
|
62.8 years
STANDARD_DEVIATION 12.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
159 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
254 participants
n=5 Participants
|
259 participants
n=7 Participants
|
513 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from Day 0 through 30 days after the last dose of study drugOutcome measures
| Measure |
Ferric Carboxymaltose (FCM)
n=254 Participants
Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
|
Standard Medical Care (SMC)
n=259 Participants
SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
|
|---|---|---|
|
Incidence of Treatment-emergent Serious Adverse Events (SAE's)
|
11 participants
|
36 participants
|
Adverse Events
Ferric Carboxymaltose (FCM)
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Medical Care (SMC)
Serious events: 36 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=254 participants at risk
Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
|
Standard Medical Care (SMC)
n=259 participants at risk
SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
|
|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.39%
1/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Metabolism and nutrition disorders
Hypovolemia
|
0.00%
0/254 • 1 year and 2 months
|
1.2%
3/259 • 1 year and 2 months
|
|
Infections and infestations
Osteomyelitis
|
0.39%
1/254 • 1 year and 2 months
|
0.00%
0/259 • 1 year and 2 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.39%
1/254 • 1 year and 2 months
|
0.00%
0/259 • 1 year and 2 months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.39%
1/254 • 1 year and 2 months
|
1.2%
3/259 • 1 year and 2 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Gastrointestinal disorders
Ascities
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/254 • 1 year and 2 months
|
0.77%
2/259 • 1 year and 2 months
|
|
Infections and infestations
Localized infection
|
0.39%
1/254 • 1 year and 2 months
|
0.00%
0/259 • 1 year and 2 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.39%
1/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
General disorders
Catheter related complication
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Eye disorders
Vitreous hemorrhage
|
0.39%
1/254 • 1 year and 2 months
|
0.00%
0/259 • 1 year and 2 months
|
|
Nervous system disorders
Thromboembolic stroke
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Infections and infestations
Clostridial infection
|
0.39%
1/254 • 1 year and 2 months
|
0.00%
0/259 • 1 year and 2 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Renal and urinary disorders
Azotemia
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.39%
1/254 • 1 year and 2 months
|
0.00%
0/259 • 1 year and 2 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/254 • 1 year and 2 months
|
0.77%
2/259 • 1 year and 2 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Cardiac disorders
Angina pectoris
|
0.39%
1/254 • 1 year and 2 months
|
0.00%
0/259 • 1 year and 2 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Infections and infestations
Urosepsis
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
|
Infections and infestations
Cellulitis
|
0.39%
1/254 • 1 year and 2 months
|
0.00%
0/259 • 1 year and 2 months
|
|
Infections and infestations
Catheter sepsis
|
0.00%
0/254 • 1 year and 2 months
|
0.39%
1/259 • 1 year and 2 months
|
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