Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pedi… (NCT03523117) | Clinical Trial Compass
CompletedPhase 3
Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA
United States79 participantsStarted 2019-01-31
Plain-language summary
The primary objective of this study is to demonstrate the efficacy and safety of intravenous ferric carboxymaltose (FCM), compared to oral iron, in pediatric participants who have iron deficiency anemia.
Who can participate
Age range1 Year – 17 Years
SexALL
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Inclusion criteria
✓. Male or female participants 1 to 17 years of age with assent to participation and his/her parent or guardian is willing and able to sign the informed consent approved by the Independent Review Board / Ethics Committee.
✓. Screening Hgb \<11 g/dL.
✓. Screening ferritin ≤300 ng/mL and transferrin saturation (TSAT) \<30%.
✓. Participants must have a documented history of an inadequate response to any oral iron therapy for at least 8 weeks (56 days) prior to randomization.
✓. For participants who are receiving an erythropoietin stimulating agent (ESA): stable ESA therapy (+/- 20% of current dose) for at least 8 weeks prior to the qualifying screening visit and no ESA dosing or product changes anticipated for the length of the trial.
✓. Participants undergoing treatment for inflammatory bowel disease (IBD) must be on stable therapy for at least 8 weeks prior to consent.
Exclusion criteria
✕. Known history of hypersensitivity reaction to any component of FCM.
✕. Previous randomization and treatment in this study or any other clinical study of FCM or VIT-45.
✕. History of acquired iron overload, hemochromatosis, or other iron accumulation disorders.
✕. Chronic kidney disease participants on hemodialysis.
✕. History of significant diseases of the liver, hematopoietic system, cardiovascular system, psychiatric disorder, or other conditions which, on the opinion of the investigator, may place a subject at added risk for participation in the study.