Anemia
Conditions
Brief summary
The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure
Interventions
DRUGFerric Carboxymaltose
Sponsors
American Regent, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male or Female 18 to 85 years of age * NDD-CKD Patients * TSAT \</= 25% * Hgb \</= 11.5 * Ferritin \</= 300 * HD-CKD Patients * TSAT \</= 30% * Hgb \</= 12 * Ferritin \</= 500
Exclusion criteria
* Previous participation in a FCM trial * Known Hypersensitivity to FCM * History of anemia other that anemia due to chronic renal failure * Current history of GI bleeding * Received IV Iron within the last 30 Days * Anticipated need for surgery * Malignancy history * AST or ALT greater than normal * Received an investigational drug within 30 days of screening * Pregnant or sexually active females who are not willing to use an effective form of birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment-emergent Serious Adverse Events (SAE's) | from Day 0 through 30 days after the last dose of study drug |
Countries
United States
Participant flow
Recruitment details
Hospitals and medical clinics
Participants by arm
| Arm | Count |
|---|---|
| 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. | 254 |
| Standard Medical Care (SMC) SMC for IDA (as determined by the Investigator) for treating CKD related anemia. | 259 |
| Total | 513 |
Baseline characteristics
| Characteristic | Standard Medical Care (SMC) | Ferric Carboxymaltose (FCM) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 133 Participants | 127 Participants | 260 Participants |
| Age, Categorical Between 18 and 65 years | 126 Participants | 127 Participants | 253 Participants |
| Age, Continuous | 63.1 years STANDARD_DEVIATION 12.11 | 62.5 years STANDARD_DEVIATION 12.81 | 62.8 years STANDARD_DEVIATION 12.46 |
| Region of Enrollment United States | 259 participants | 254 participants | 513 participants |
| Sex: Female, Male Female | 153 Participants | 159 Participants | 312 Participants |
| Sex: Female, Male Male | 106 Participants | 95 Participants | 201 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 254 | 0 / 259 |
| serious Total, serious adverse events | 11 / 254 | 36 / 259 |
Outcome results
Primary
Incidence of Treatment-emergent Serious Adverse Events (SAE's)
Time frame: from Day 0 through 30 days after the last dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Incidence of Treatment-emergent Serious Adverse Events (SAE's) | 11 participants |
| Standard Medical Care (SMC) | Incidence of Treatment-emergent Serious Adverse Events (SAE's) | 36 participants |