A Study to Characterize the PK and PD Profile of IV FCM in Pediatric Subjects 1-17 Years Old With IDA

Summary

This is a Phase II, open-label, non-randomized, multi-center, single arm study to characterize the pharmacokinetic and pharmacodynamics (PK/PD) profile of Ferric Carboxymaltose dosing in pediatric subjects with IDA after receiving either a 7.5 mg/kg or 15 mg/kg dose of Ferric Carboxymaltose.

Timeline

Start

2015-02-19

Primary completion

2017-01-22

Completion

2017-06-01

Publications

• Korczowski B, Farrell C, Falone M, Blackman N, Rodgers T. Safety, pharmacokinetics, and pharmacodynamics of intravenous ferric carboxymaltose in children with iron deficiency anemia. Pediatr Res. 2023 Oct;94(4):1547-1554. doi: 10.1038/s41390-023-02644-9. Epub 2023 May 19.

Drugs

Indications