Phase 3
Completed N=703
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia
Source: ClinicalTrials.gov NCT00703937 ↗Enrolled (actual)
703
Serious AEs
4.0%
Results posted
Nov 2013
Primary outcomePrimary: Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC — 17; 11 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 Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC |
17; 11 | — |
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 Hemoglobin (Hgb) ≤ 11g/dL
- Screening Visit ferritin ≤ 100ng/mL or ≤ 300 ng/mL 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
- AST or 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 willing to use an effective form of birth control
Data sourced from ClinicalTrials.gov (NCT00703937). 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.