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A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Ferrlecit® vs Oral Iron in Iron Deficient Patients With Chronic Kidney Disease
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are not receiving erythropoietic agents (hormones that stimulate the bone marrow to make more red blood cells).
Details
| Lead sponsor | Watson Pharmaceuticals |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 89 |
| Start date | 2003-04 |
| Completion | 2004-09 |
Conditions
- Anemia, Iron-Deficiency
- Kidney Failure, Chronic
Interventions
- Sodium Ferric Gluconate Complex in Sucrose Injection
- Ferrous sulfate tablets
Primary outcomes
- Change in Hemoglobin (Hgb) — Baseline to 10 weeks
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.
Countries
United States, Puerto Rico