NCT00239616

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter pharmacokinetic study of Hemodialysis (HD) or Peritoneal Dialysis (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.

Detailed 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.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	Iron Sucrose injection	Iron sucrose 100 mg dose

Timeline

• Start date: 2002-06-05
• Primary completion: 2003-09-15
• Completion: 2003-09-15
• First posted: 2005-10-17
• Last updated: 2025-05-18