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

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Iron

Criteria

Inclusion Criteria:

• Age between 12 and 18

• History of Chronic Renal Failure requiring HD or PD

• Hgb
• Ferritin < 800 ng/ml

• TSAT < 50%

• Receiving EPO

Exclusion Criteria:

• Known Sensitivity to Iron Sucrose

• Severe Concomitant disease of the liver or cardiovascular system

• Serious bacterial Infection

• Pregnancy / Lactation

• Active Hepatitis

• Patients with Causes of iron deficiency other that Chronic Renal Failure

• Blood Transfusion

• Body Weight < 25 KG

• Currently being treated for Asthma

• Received investigational drug within last 30 days