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

Iron Deficiency Anemia (IDA) Clinical Trial

Official title:
A Multi-center, Open-label, Single Arm Study to Characterize the Pharmacokinetics and Pharmacodynamics Profile of Intravenous Ferric Carboxymaltose in Pediatric Subjects 1-17 Years Old With Iron Deficiency Anemia (IDA)

Status Completed

Clinical Trial 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.

Clinical Trial Description

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02410213
Study type	Interventional
Source	American Regent, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	February 19, 2015
Completion date	June 1, 2017

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See also
Status	Clinical Trial	Phase
Completed	`NCT01984554` - Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency Anemia	N/A
Completed	`NCT01129843` - Directly Observed Iron Supplementation to Treat Anemia	N/A
Completed	`NCT03754998` - Community Interventions to Improve Iron and Iodine Status in Mother and Child Dyads in Northern Ghana	N/A
Active, not recruiting	`NCT01950247` - Trial to Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron and to Compare Safety, Effect on Quality of Life, and Resource Utilization of Injectafer vs Intravenous Standard of Care for the Treatment of IDA in an Infusion Center Setting	Phase 4