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 Details — Status: Completed

Administrative data

• NCT number: NCT00239616
• Other study ID #: 1VEN01016
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2005
• Last updated: January 22, 2018
• Start date: June 2002
• Est. completion date: November 2003

Study information

• Verified date: January 2018
• Source: Luitpold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• Age between 12 and 18

• History of Chronic Renal Failure requiring HD or PD

• Hgb </= 13 g/dL

• 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

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• iron sucrose injection USP

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Luitpold Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Parameters
Secondary	Incidence of safety events