Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Evaluation of Efficacy and Safety of Ferric Carboxymaltose in Patients With Iron Deficiency Anemia and Impaired Renal Function

Conditions
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Iron Deficiency Anemia, Impaired Renal Function

Intervention / Treatment
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* Drug: Ferric Carboxymaltose (FCM)
* Drug: Iron Sucrose (Venofer)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferric Carboxymaltose (FCM)<br>2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg | Drug: Ferric Carboxymaltose (FCM)<br>* 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg<br>|
| Active Comparator: Iron Sucrose (Venofer)<br>5 doses of 200 mg for a total cumulative dose of 1000 mg | Drug: Iron Sucrose (Venofer)<br>* 5 doses of 200 mg for a total cumulative dose of 1000 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study. |  | Day 56 | 
| Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population. | The primary composite safety endpoint was defined as death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization or medical intervention, arrhythmias, protocol-defined hypersensitive events, and protocol-defined hyposensitive events. | Day 120 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IDA