Expired Study
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Norristown, Pennsylvania 19403


The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.


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



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Norristown, Pennsylvania 19403
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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