Endovenous Versus Liposomal Iron in CKD

NCT01864161 Phase 4 COMPLETED

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.

Details

Lead sponsor	Federico II University
Phase	Phase 4
Status	COMPLETED
Enrolment	100
Start date	2011-10
Completion	2013-05

Conditions

• Iron Deficiency Anemia
• Chronic Kidney Disease

Interventions

• gluconate iron
• Liposomal iron

Primary outcomes

• modification in hemoglobin levels — 3 months

Countries

Italy