Endovenous Versus Liposomal Iron in CKD

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Iron Deficiency Anemia
• Intervention / Treatment: Drug: Liposomal iron; Drug: gluconate iron

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Federico II University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years;
• Signed written informed consent;
• Glomerular filtration rate (GFR) ≤ 60 mL/min (MDRD GFR calculated according to 4 variables);
• hemoglobin ≤ 12g/dL;
• Ferritin ≤ 100ng/mL with transferrin saturation (TSAT) ≤ 25%;
• If erythropoiesis stimulating agents (ESA) therapy, stable dose for at least three months;

Exclusion Criteria:

• Infectious diseases;
• bleeding in the preceding six months;
• History of malignancy tumor in the last 3 years;
• Anemia case different from that resulting from CKD;
• vitamin B12 and folate deficiency;
• Surgery of any kind in the last three months;
• systemic haematological disease;
• Blood Transfusions, therapy with intravenous or oral iron in the last three months;
• Severe liver disease / test positive for hepatitis C virus (HCV) and hepatitis B virus (HBV);
• Abuse of alcohol and drugs in the preceding six months;
• immunosuppressive therapy ;
• Significant weight loss;
• Pregnancy or breast-feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oral liposomal iron; patients receive a dose of liposomal 30 mg/die iron (equivalent to 1 cp Sideral forte).	Drug: Liposomal iron; Sideral forte 30 mg/die; Other Names: Sideral forte
Active Comparator: endovenous iron; 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	Drug: gluconate iron; FERLIXIT fl 15mg/kg divided into weekly administrations of 125mg up to a maximum of 1000mg; Other Names: FERLIXIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
modification in hemoglobin levels	3 months

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: May 24, 2013
• First Submitted That Met QC Criteria: May 28, 2013
• First Posted (Estimate): May 29, 2013

Study Record Updates

• Last Update Posted (Estimate): July 24, 2014
• Last Update Submitted That Met QC Criteria: July 23, 2014
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Kidney Diseases; Renal Insufficiency, Chronic; Anemia, Iron-Deficiency; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: BIANCA79