Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients

Phase 4 Completed 23 enrolled Watson Pharmaceuticals

Non-randomizedSingle-groupOpen-labelTreatment

Summary

A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.

Timeline

Start: 2003-04
Primary completion: 2004-03
Completion: 2005-02

Publications

Results Warady BA, Zobrist RH, Finan E; Ferrlecit Pediatric Study Group. Sodium ferric gluconate complex maintenance therapy in children on hemodialysis. Pediatr Nephrol. 2006 Apr;21(4):553-60. doi: 10.1007/s00467-006-0042-5. Epub 2006 Mar 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sodium Ferric Gluconate Complex	Unknown	1 mg/kg	Intravenous

Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients

Summary

Timeline

Publications

Drugs

Indications