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

American Regent

Status and phase: Completed; Phase 2

Conditions: Anemia

Treatments: Drug: Iron Sucrose injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00239616

1VEN01016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 12 and 18 years
• History of Chronic Renal Failure requiring HD or PD
• Hgb </= 13 g/dL
• Ferritin < 800 ng/ml
• Transferrin Saturation (TSAT) < 50%
• Receiving epoetin

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 kilograms
• Currently being treated for Asthma
• Received investigational drug within last 30 days

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Iron Sucrose

Experimental group

Description:

A single 100 mg dose (1 vial), 20 mg/min injected over 5 minutes

Treatment:

Drug: Iron Sucrose injection