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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:
ClinicalTrials.gov Identifier:
NCT00239616
First Posted: October 17, 2005
Last Update Posted: March 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Luitpold Pharmaceuticals
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239616


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

ClinicalTrials.gov Identifier: NCT00239616     History of Changes
Other Study ID Numbers: 1VEN01016
First Submitted: October 13, 2005
First Posted: October 17, 2005
Last Update Posted: March 17, 2011
Last Verified: March 2011

Keywords provided by Luitpold Pharmaceuticals:
Anemia
Pharmacokinetics

Additional relevant MeSH terms:
Iron
Ferric oxide, saccharated
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics