Sponsor study identifier
interventional
100
1 country
1
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2013
Actual (reported)Study Completion
May 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
May 2013
Actual (reported)May 2013
Actual (reported)May 24, 2013
Actual (reported)May 29, 2013
Actual (reported)modification in hemoglobin levels
3 months
patients receive a dose of liposomal 30 mg/die iron (equivalent to 1 cp Sideral forte).
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
FERLIXIT fl 15mg/kg divided into weekly administrations of 125mg up to a maximum of 1000mg
Sideral forte 30 mg/die
Federico II University
Naples, Naples, 80131, Italy
100 participants (actual enrollment reported by the registry).
First Submitted
May 24, 2013
First Posted
May 29, 2013
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Paricalcitol Effect on Anemia in CKD
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Primary Completion
May 2013
Actual (reported)Study Completion
May 2013
Actual (reported)Last Updated
July 24, 2014
Record last verified: 2013-01
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Source: ClinicalTrials.gov.
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