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Anemia is a common complication in patients with chronic kidney disease (CKD). In addition to erythropoietin deficiency, many studies have identified iron deficiency as a cause of anemia in CKD patients. Most patients with CKD are iron deficient because of: inadequate intake and absorption, gastroenteric bleeding, urinary iron loss in patient with significant proteinuria. The iron treatment is pivotal to manage anemic patients with CKD: the prescription of iron is usually oral because of practicality and safety, but often it is inevitable to administer intravenous iron because of gastroenteric malabsorption, intolerance to oral administration, irregular intake. There're few randomized controlled studies about the efficacy of oral iron versus intravenous iron in patients not on dialysis; most of them demonstrate superiority of intravenous therapy to restore iron deficiency and hemoglobin levels. A particular formulation of iron, liposomal iron has a high gastroenteric absorption and high bioavailability with lower incidence of side effects. The investigators study aims to evaluate the efficacy of treatment with liposomal oral iron compared to intravenous iron in CKD anemic patients not on dialysis in the presence of iron deficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral liposomal iron | Experimental | patients receive a dose of liposomal 30 mg/die iron (equivalent to 1 cp Sideral forte). |
|
| endovenous iron | Active Comparator | patients receive a total dose 1000 mg of intravenous iron gluconate divided into administrations of 125 mg diluted in 250 mL normal saline infused weekly for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gluconate iron | Drug | FERLIXIT fl 15mg/kg divided into weekly administrations of 125mg up to a maximum of 1000mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| modification in hemoglobin levels | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federico II University | Naples | Naples | 80131 | Italy |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C043193 | ferlixit |
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| Liposomal iron | Drug | Sideral forte 30 mg/die |
|
|
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |