Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients - Full Text View

Purpose

A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.

Condition	Intervention	Phase
Anemia	Drug: Sodium Ferric Gluconate Complex in Sucrose.	Phase IV

MedlinePlus related topics:

Anemia Dialysis Kidney Failure

ChemIDplus related topics:

Epoetin alfa Erythropoietin Sucrose Sodium ferric gluconate complex D-Gluconic acid, monosodium salt Gluconic acid Manganese gluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Open-Label, Multi-Center Study of the Safety and Efficacy of Ferrlecit® in the Maintenance of Iron Stores in Pediatric Hemodialysis Patients Receiving Epoetin

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:

Primary objective was to evaluate the effects of intravenous administration of Ferrlecit on the maintenance of the iron indices, within ranges that were indicative of an iron-replete state in pediatric hemodialysis patients receiving erythopoietin.

Secondary Outcome Measures:

Evaluate the effect of intravenous administration of Ferrlecit on hematology parameteres, on EPO dose, and safety.

Estimated Enrollment:	60
Study Start Date:	April 2003
Estimated Study Completion Date:	March 2004

Eligibility

Ages Eligible for Study:	2 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female pediatric ESRD, Patients >_ 2 and <_ 16 years of age, whose legally authorized representative provided signed informed consent.
Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy.
Predetermined TSAT and serum Ferritin (at the screening visit).
Receiving a stable EPO dosing regimen.

Exclusion Criteria:

Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing.
Hypersensitivity to Ferrlecit or any of its inactive components.
High TSAT level.
High Serum Ferritin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224003

Locations


United States, Alabama

	Birmingham, Alabama, United States

United States, California

	Stanford, California, United States

	San Diego, California, United States

	Los Angeles, California, United States

United States, Georgia

	Atlanta, Georgia, United States

United States, Massachusetts

	Boston, Massachusetts, United States

United States, Missouri

	Kansas City, Missouri, United States

United States, New York

	Bronx, New York, United States

United States, Texas

	Dallas, Texas, United States

United States, Washington

	Seattle, Washington, United States

Sponsors and Collaborators

Watson Pharmaceuticals

Investigators


Investigator:	Gary Hoel, RPh, PhD	Watson Pharmaceuticals

More Information

Study ID Numbers:	FRO2001
First Received:	September 13, 2005
Last Updated:	January 4, 2006
ClinicalTrials.gov Identifier:	NCT00224003
Health Authority:	United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:

Anemia

Study placed in the following topic categories:

Epoetin Alfa

Ferric Compounds

Hematologic Diseases

Ferric gluconate

Anemia

Iron

Additional relevant MeSH terms:

Hematinics

Therapeutic Uses

Hematologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Watson Pharmaceuticals
Information provided by:	Watson Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00224003