Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients - Full Text View

Purpose

This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal guardian had provided signed informed consent and satisfied the inclusion and exclusion criteria.

Condition	Intervention	Phase
Anemia	Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection)	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, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Official Title:	Randomized Double-Blind Parallel Group MultiCenter Study of the Efficacy of Two Doses of Ferrlecit® in Treatment of Iron Deficiency in Pediatric Hemodialysis Patients Receiving Epoetin.

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:

Demonstrate and compare effectiveness of two Ferrlecit® doses in increasing hemoglobin in iron-deficient pediatric hemodialysis patients requiring repletion iron therapy.

Secondary Outcome Measures:

Evaluate single-dose pharmacokinetics of Ferrlecit® in iron deficient pediatric hemodialysis patients and to access the safety profile of Ferrlecit® in pediatric hemodialysis patients.

Study Start Date:

June 2003

Eligibility

Ages Eligible for Study:	2 Years to 16 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Male or female pediatric end-stage renal disease (ESRD) patients.
Predetermined TSAT and serum ferritin levels
Receiving chronic hemodialysis therapy with an identified need for repletion iron therapy.
Receiving a stable epoetin (EPO) dosing regimen.

Exclusion Criteria:

Receipt of any form of iron supplements during the 4 weeks prior to the first Ferrlecit® dosing.
Blood transfusion.
Hypersensitivity to Ferrlecit®.
Significant inflammatory conditions.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223964

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, Massachusetts

	BOSTON, Massachusetts, United States

United States, Missouri

	KANSAS CITY, Missouri, United States

United States, New York

	BRONX, New York, United States

United States, Washington

	SEATTLE, Washington, United States

Mexico

	MEXICO CITY, Mexico

	ARUASCALIENTES, Mexico

Poland

	KRAKOW, Poland

	LODZ, Poland

	WROCLAW, Poland

	GDANSK, Poland

	ZABRZE, Poland

	LUBLIN, Poland

	BIALYSTOK, Poland

	TORUM, Poland

	SZCZECIN, Poland

Russian Federation

	MOSCOW, Russian Federation

	SAINT PETERSBURG, Russian Federation

	TARTARSTAN, Russian Federation

	BASHKORTOSTAN, Russian Federation

Serbia and Montenegro

	BELGRADE, Serbia and Montenegro

Sponsors and Collaborators

Watson Pharmaceuticals

Investigators


Study Director:	GARY HOEL, RPh, PhD	WATSON LPHARMACEUTICAL

More Information

Study ID Numbers:	FR01006
First Received:	September 13, 2005
Last Updated:	July 20, 2006
ClinicalTrials.gov Identifier:	NCT00223964
Health Authority:	United States: Food and Drug Administration