2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-Deficiency Anemia in Peritoneal Dialysis Patients. - Full Text View

Purpose

This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.

Condition	Intervention	Phase
Iron Deficiency Anemia	Drug: Sodium Ferric Gluconate Complex in Sucrose 125 mg Drug: Sodium Ferric Gluconate Complex in Sucrose 250 mg Drug: Oral Iron	Phase II Phase III

MedlinePlus related topics:

Anemia

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, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Multi-Center, Randomized, Open Label Study of the Efficacy and Safety of Two Doses of Ferrlecit Versus Oral Iron to Treat Iron-Deficiency Anemia in Peroneal Dialysis Patients Receiving Erythropoietin.

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:

Comparison of two doses of Ferrlecit versus oral iron.

Secondary Outcome Measures:

Compassion between treatments - change from baseline in hematological parameters, number and percentage of patients classified as responders/nonresponders and safety.

Enrollment:	146
Study Start Date:	December 2003
Study Completion Date:	November 2004
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Sodium Ferric Gluconate Complex in Sucrose 125 mg
2: Experimental	Drug: Sodium Ferric Gluconate Complex in Sucrose 250 mg
3: Active Comparator	Drug: Oral Iron

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female, at least 18 years of age.
Received maintenance peritoneal dialysis therapy for at least 4 weeks.
Was expected to remain on peritoneal dialysis therapy for duration of study.
Had a predetermined low hemoglobin and TSAT levels.
Signed patient informed consent.

Exclusion Criteria:

Had a predetermined serum levels of Ferritin and TSAT
Pregnant or lactating.
Had a serious concomitant medical disorder incompatible with participation in the study.
Had a known hypersensitivity to Ferrlecit or any of its components.
Unable to cooperate or comply with the protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223977

Show 43 Study Locations

Sponsors and Collaborators

Watson Pharmaceuticals

Investigators


Study Chair:	Gary Hoel, RPh, PhD	Watson Pharmaceuticals

More Information

Responsible Party:	Watson Laboratories Inc ( Gary Hoel, PhD )
Study ID Numbers:	FR03001
First Received:	September 13, 2005
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00223977
Health Authority:	United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:

Anemia.

Study placed in the following topic categories:

Epoetin Alfa

Metabolic Diseases

Ferric Compounds

Hematologic Diseases

Anemia

Iron Metabolism Disorders

Anemia, Iron-Deficiency

Malnutrition

Ferric gluconate

Nutrition Disorders

Metabolic disorder

Iron

Deficiency Diseases

Additional relevant MeSH terms:

Hematinics

Growth Substances

Therapeutic Uses

Physiological Effects of Drugs

Hematologic Agents

Anemia, Hypochromic

Trace Elements

Micronutrients

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Watson Pharmaceuticals
Information provided by:	Watson Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00223977