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

This study has been completed.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00239616
First received: October 13, 2005
Last updated: March 16, 2011
Last verified: March 2011
History of Changes

October 13, 2005
March 16, 2011
June 2002
Not Provided
Pharmacokinetic Parameters
Same as current
Complete list of historical versions of study NCT00239616 on ClinicalTrials.gov Archive Site
Incidence of safety events
Same as current
Not Provided
Not Provided
 
Pharmacokinetic Study 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

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.

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.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anemia
Drug: iron sucrose injection USP
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
November 2003
Not Provided

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
Both
12 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00239616
1VEN01016
Not Provided
Not Provided
Luitpold Pharmaceuticals
Not Provided
Study Director: Antoinette Mangione, MD, PharmD Luitpold Pharmaceuticals
Luitpold Pharmaceuticals
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP