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

Completed · Phase 4

Conditions studied: Anemia

In brief

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.

Key facts

Study ID

NCT00223964

Run by

Watson Pharmaceuticals

People needed

59

Starts

2003-06-01

Last updated by the study team

2012-08-14

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

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 — Boston, Massachusetts, United States
• Study site — Kansas City, Missouri, United States
• Study site — The Bronx, New York, United States
• Study site — Seattle, Washington, United States
• Study site — Aruascalientes, Mexico
• Study site — Mexico City, Mexico
• Study site — Bialystok, Poland
• Study site — Gdansk, Poland
• Study site — Krakow, Poland
• Study site — Lodz, Poland
• Study site — Lublin, Poland
• Study site — Szczecin, Poland
• Study site — Torum, Poland
• Study site — Wroclaw, Poland
• Study site — Zabrze, Poland
• Study site — Bashkortostan, Russia
• Study site — Moscow, Russia
• Study site — Saint Petersburg, Russia
• Study site — Tartarstan, Russia
• Study site — Belgrade, Serbia

Full record on ClinicalTrials.gov

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