NCT01864161

Endovenous Versus Liposomal Iron in CKD

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Iron Deficiency Anemia
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	gluconate iron	FERLIXIT fl 15mg/kg divided into weekly administrations of 125mg up to a maximum of 1000mg
DRUG	Liposomal iron	Sideral forte 30 mg/die

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2013-05-29
• Last updated: 2014-07-24

Locations

1 site across 1 country: Italy