Clinical Trial Details
| Trial ID: | L1172 |
| Source ID: | NCT00224055 |
| Associated Drug: | Sodium Ferric Gluconate Complex In Sucrose Injection |
| Title: | Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00224055/results |
| Conditions: | Anemia, Iron-Deficiency|Kidney Failure, Chronic |
| Interventions: | DRUG: Sodium Ferric Gluconate Complex in Sucrose Injection|DRUG: Ferrous sulfate tablets |
| Outcome Measures: | Primary: 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: 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: | 89 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2003-04 |
| Completion Date: | 2004-09 |
| Results First Posted: | 2012-03-29 |
| Last Update Posted: | 2012-03-29 |
| Locations: | 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|Bronx, 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/NCT00224055 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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