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

NCT ID: NCT00239616

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-05
• Study Completion Date: 2003-09-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Iron Sucrose

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

Group Type: EXPERIMENTAL

Iron Sucrose injection

Intervention Type: DRUG

Iron sucrose 100 mg dose

Interventions

Iron Sucrose injection

Iron sucrose 100 mg dose

Intervention Type: DRUG

Other Intervention Names

Venofer

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Regent, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark A Falone, MD

Role: STUDY_DIRECTOR

American Regent, Inc.

Other Identifiers

1VEN01016

Identifier Type: -

Identifier Source: org_study_id