Phase 3
N=2,584
Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function
Iron Deficiency Anemia · Impaired Renal Function
Bottom Line
View on ClinicalTrials.gov: NCT00981045 ↗Enrolled (actual)
2,584
Serious AEs
15.6%
Results posted
Oct 2013
Primary outcome: Primary: Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study. — 1.13; 0.92 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ferric Carboxymaltose (FCM) (Drug); Iron Sucrose (Venofer) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- American Regent, Inc.
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study. |
1.13; 0.92 | — |
| PRIMARY Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population. |
175; 156 | — |
Summary
The primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal function.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects > or = to 18 years of age.
- Chronically impaired renal function.
- Screening visit central laboratory hemoglobin < or = to 11.5 g/dL.
- Screening ferritin < or = to 100 ng/mL or < or = to 300 when transferrin saturation (TSAT) is < or = to 30%.
- If on an erythropoiesis stimulating agent(ESA) a stable dose (+/- 20%) for 4 weeks prior to randomization.
Exclusion Criteria
- Known hypersensitivity reaction to any component of ferric carboxymaltose (FCM) or Venofer.
- Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
- Requires dialysis for treatment of chronic kidney disease OR is being considered for initiation of dialysis during the time period of this trial.
- No evidence of iron deficiency.
- Any non-viral infection.
- AST or ALT at screening as determined by central labs greater than 1.5 times the upper limit of normal.
- Known positive hepatitis with evidence of active disease.
- Received an investigational drug within 30 days of screening.
- Alcohol or drug abuse within the past 6 months.
- Hemochromatosis or other iron storage disorders.
- Estimated life expectancy of less than 6 months, or for cancer patients, an ECOG Performance Status greater than 1.
- Any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
- Pregnant or sexually-active female subjects who are not willing to use an acceptable form of contraception.
Data sourced from ClinicalTrials.gov (NCT00981045). 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.