Status:
COMPLETED
Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients
Lead Sponsor:
Watson Pharmaceuticals
Conditions:
Anemia
Eligibility:
All Genders
2-16 years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00223964
Start Date
June 1 2003
Last Update
August 14 2012
Active Locations (24)
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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