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Pharmacokinetic Study of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin

Anemia Clinical Trial

Official title:
Open-label Multicenter, Pharmacokinetic Study of a Single Dose of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin

Clinical Trial Summary

This is an open-label, multicenter pharmacokinetic study of HD od PD patients receiving erythropoietin. Patients were administered 100mg of iron sucrose undiluted by slow IV push over 5 minutes. Patients underwent serial blood draws and were subsequently followed for 7 days for safety endpoints.

Clinical Trial Description

This is an open-label, multicenter pharmacokinetic study of HD of adolescent PD patients receiving erythropoietin. Patients between the ages of 12 and 18 were administered 100mg of iron sucrose, undiluted by slow IV push over 5 minutes, and underwent serial blood draws. The patients were subsequently followed for 7 days for safety endpoints. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00239616
Study type Interventional
Source Luitpold Pharmaceuticals
Contact
Status Completed
Phase Phase 4
Start date June 2002
Completion date November 2003
View Details
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