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

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Watson Pharmaceuticals
• Treatments: Ferric Compounds; Ferric gluconate

Criteria

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