Phase 4 Completed N=23 Treatment

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

Anemia

Source: ClinicalTrials.gov NCT00224003 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Sep 2009

Primary outcomePrimary: Serum Ferritin — 26.7 ng/mL

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum Ferritin	26.7	—
PRIMARY Transferrin Saturation	2.0	—
SECONDARY Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.	—	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00224003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.