Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients
Phase 4
Completed
- Conditions
- Anemia
- Interventions
- Registration Number
- NCT00223964
- Lead Sponsor
- Watson Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dose level 2 Ferrlecit (sodium ferric gluconate complex in sucrose injection) 3 mg/kg dose level 1 Ferrlecit (sodium ferric gluconate complex in sucrose injection) 1.5 mg/kg
- Primary Outcome Measures
Name Time Method Demonstrate and compare effectiveness of two Ferrlecit® doses in increasing hemoglobin in iron-deficient pediatric hemodialysis patients requiring repletion iron therapy. 2 weeks
- Secondary Outcome Measures
Name Time Method Evaluate single-dose pharmacokinetics of Ferrlecit® in iron deficient pediatric hemodialysis patients and to access the safety profile of Ferrlecit® in pediatric hemodialysis patients. 48 hours