Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients
NCT ID: NCT00224055
Last Updated: 2012-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
89 participants
INTERVENTIONAL
2003-04-30
2004-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IV iron
Sodium ferric gluconate
Sodium Ferric Gluconate Complex in Sucrose Injection
Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks
oral iron
ferrous sulfate
Ferrous sulfate tablets
ferrous sulfate, 325 mg oral, three times daily for 6 weeks
Interventions
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Sodium Ferric Gluconate Complex in Sucrose Injection
Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks
Ferrous sulfate tablets
ferrous sulfate, 325 mg oral, three times daily for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* Iron deficiency
* Moderate to severe chronic kidney disease
Exclusion Criteria
* Known sensitivity to Ferrlecit® or any of its components
* Receiving therapy with erythropoietic agent
* Clinically unstable
18 Years
ALL
No
Sponsors
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Watson Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Naomi Dahl, Pharm.D.
Role: STUDY_DIRECTOR
Watson Laboratories, Inc.
Locations
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Tucson, Arizona, United States
Los Angeles, California, United States
Palo Alto, California, United States
San Diego, California, United States
Hines, Illinois, United States
Indianapolis, Indiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Springfield, Massachusetts, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
Birmingham, New York, United States
Mineola, New York, United States
New York, New York, United States
The Bronx, New York, United States
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Charlotte, South Carolina, United States
Chattanooga, Tennessee, United States
Memphis, Tennessee, United States
Houston, Texas, United States
Fairfax, Virginia, United States
San Juan, , Puerto Rico
Countries
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References
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Agarwal R, Rizkala AR, Bastani B, Kaskas MO, Leehey DJ, Besarab A. A randomized controlled trial of oral versus intravenous iron in chronic kidney disease. Am J Nephrol. 2006;26(5):445-54. doi: 10.1159/000096174. Epub 2006 Oct 11.
Other Identifiers
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FER0202
Identifier Type: -
Identifier Source: org_study_id
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