Phase 3
N=735
Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00704353 ↗Enrolled (actual)
735
Serious AEs
1.9%
Results posted
Nov 2013
Primary outcome: Primary: Number of Participants With Treatment-emergent Serious Adverse Events (SAE's) — 5; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ferric Carboxymaltose (Drug); Standard Medical Care (SMC) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- American Regent, Inc.
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Serious Adverse Events (SAE's) |
5; 9 | — |
Summary
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent
Eligibility Criteria
Inclusion Criteria
- Subjects ≥18 years of age and able to give informed consent
- Iron deficiency is the primary etiology of anemia
- Screening Visit central laboratory Hgb indicative of anemia ≤12 g/dL
- Screening Visit ferritin indicative of iron deficiency anemia ≤100 ng/mL or ≤300 when TSAT was ≤30%
Exclusion Criteria
- Previous participation in a FCM trial
- Known hypersensitivity reaction to FCM
- Requires dialysis for treatment of chronic kidney disease
- Current anemia not attributed to iron deficiency
- Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
- Anticipated need for surgery requiring general anesthesia 30 days prior to screening or during the study period
- AST of ALT greater than 1.5 times the upper limit of normal
- Received an investigational drug within 30 days of screening
- Pregnant or sexually-active females who are not able to use an effective form of birth control
Data sourced from ClinicalTrials.gov (NCT00704353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.