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

Watson Pharmaceuticals

Status and phase

Completed

Phase 4

Conditions

Anemia

Treatments

Drug: Sodium Ferric Gluconate Complex in Sucrose.

Study type

Interventional

Funder types

Industry

Identifiers

NCT00224003

FRO2001

FDA

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

2 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female pediatric ESRD, Patients >_ 2 and <_ 16 years of age, whose legally authorized representative provided signed informed consent.
Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy.
Predetermined TSAT and serum Ferritin (at the screening visit).
Receiving a stable EPO dosing regimen.

Exclusion criteria

Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing.
Hypersensitivity to Ferrlecit or any of its inactive components.
High TSAT level.
High Serum Ferritin