Endovenous Versus Liposomal Iron in CKD

NCT ID: NCT01864161

Last Updated: 2014-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

oral liposomal iron

patients receive a dose of liposomal 30 mg/die iron (equivalent to 1 cp Sideral forte).

Group Type: EXPERIMENTAL

Liposomal iron

Intervention Type: DRUG

Sideral forte 30 mg/die

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

Group Type: ACTIVE_COMPARATOR

gluconate iron

Intervention Type: DRUG

FERLIXIT fl 15mg/kg divided into weekly administrations of 125mg up to a maximum of 1000mg

Interventions

gluconate iron

FERLIXIT fl 15mg/kg divided into weekly administrations of 125mg up to a maximum of 1000mg

Intervention Type: DRUG

Liposomal iron

Sideral forte 30 mg/die

Intervention Type: DRUG

Other Intervention Names

FERLIXIT; Sideral forte

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Eleonora Riccio

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federico II University

Naples, Naples, Italy

Countries

Italy

Other Identifiers

BIANCA79

Identifier Type: -

Identifier Source: org_study_id