Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal guardian had provided signed informed consent and satisfied the inclusion and exclusion criteria.

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

Details

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

Criteria

Inclusion Criteria:

• Male or female pediatric end-stage renal disease (ESRD) patients.

• Predetermined TSAT and serum ferritin levels

• Receiving chronic hemodialysis therapy with an identified need for repletion iron therapy.

• Receiving a stable epoetin (EPO) dosing regimen.

Exclusion Criteria:

• Receipt of any form of iron supplements during the 4 weeks prior to the first Ferrlecit® dosing.

• Blood transfusion.

• Hypersensitivity to Ferrlecit®.

• Significant inflammatory conditions.