Phase 3
Completed N=160
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia
Source: ClinicalTrials.gov NCT00704028 ↗Enrolled (actual)
160
Serious AEs
5.0%
Results posted
Nov 2013
Primary outcomePrimary: The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's) — 60; 59 participants
Summary
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's) |
60; 59 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects ≥18 years of age and able to give informed consent
- Iron deficiency is the primary etiology of anemia
- History of intolerance or an unsatisfactory response to oral iron
- Screening Visit central laboratory Hgb ≤11 g/dL
- Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30%
Exclusion Criteria
- Previous participation in a FCM trial
- Known hypersensitivity reaction to FCM or iron dextran
- 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 during the 30 day period prior to screening or during the study period
- AST or ALT greater than 1.5 times the upper limit of normal
- Received an investigational drug within 30 days of screening
- Women who are breastfeeding
- Pregnant or sexually-active females who are not willing to use an effective form of birth control
Data sourced from ClinicalTrials.gov (NCT00704028). 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. Informational only — not medical advice.