Status:
COMPLETED
Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients
Lead Sponsor:
Watson Pharmaceuticals
Conditions:
Anemia
Eligibility:
All Genders
2-16 years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00224003
Start Date
April 1 2003
End Date
February 1 2005
Last Update
September 28 2009
Active Locations (10)
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1
Birmingham, Alabama, United States
2
Los Angeles, California, United States
3
San Diego, California, United States
4
Stanford, California, United States