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Clinical Trial Details

Trial ID: L1225
Source ID: NCT00224042
Associated Drug: Sodium Ferric Gluconate Complex In Sucrose
Title: Effect of FerrlecitĀ® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00224042/results
Conditions: Anemia, Iron-Deficiency|Kidney Failure, Chronic
Interventions: DRUG: Sodium Ferric Gluconate complex in sucrose|DRUG: Ferrous sulfate tablets
Outcome Measures: Primary: Baseline Hemoglobin Concentration, Baseline|Change in Hemoglobin (Hgb), Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d., Baseline to 10 weeks | Secondary: Baseline Serum Ferritin Concentration, Baseline|Change in Serum Ferritin, Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d., Baseline to 10 weeks
Sponsor/Collaborators: Sponsor: Watson Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 52
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2003-04
Completion Date:
Results First Posted: 2012-03-29
Last Update Posted: 2012-03-29
Locations: Birmingham, Alabama, United States|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|St. Louis, Missouri, United States|Bronx, New York, United States|Detroit, New York, United States|Mineola, New York, United States|New York, 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
URL: https://clinicaltrials.gov/show/NCT00224042