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
  Purpose

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.


Condition Intervention Phase
Anemia
Drug: iron sucrose injection USP
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label Multicenter, Pharmacokinetic Study of a Single Dose of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Pharmacokinetic Parameters

Secondary Outcome Measures:
  • Incidence of safety events

Estimated Enrollment: 8
Study Start Date: June 2002
Estimated Study Completion Date: November 2003
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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239616

Sponsors and Collaborators
Luitpold Pharmaceuticals
Investigators
Study Director: Antoinette Mangione, MD, PharmD Luitpold Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00239616     History of Changes
Other Study ID Numbers: 1VEN01016
Study First Received: October 13, 2005
Last Updated: March 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Luitpold Pharmaceuticals:
Anemia
Pharmacokinetics

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Ferric oxide, saccharated
Ferric Compounds
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014