Endovenous Versus Liposomal Iron in CKD

Study Overview
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Brief Summary
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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.

Conditions
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Iron Deficiency Anemia, Chronic Kidney Disease

Intervention / Treatment
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* Drug: gluconate iron
* Drug: Liposomal iron


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modification in hemoglobin levels |  | 3 months |