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

Completed · Phase 4

Conditions studied: Anemia

In brief

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.

Key facts

Study ID

NCT00224003

Run by

Watson Pharmaceuticals

People needed

23

Starts

2003-04-01

Expected to finish

2005-02-01

Last updated by the study team

2009-09-28

Who can join

Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Stanford, California, United States
• Study site — Atlanta, Georgia, United States
• Study site — Boston, Massachusetts, United States
• Study site — Kansas City, Missouri, United States
• Study site — The Bronx, New York, United States
• Study site — Dallas, Texas, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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