Endovenous Versus Liposomal Iron in CKD

Chronic Kidney Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864161
• Other study ID #: BIANCA79
• Status: Completed
• Phase: Phase 4
• First received: May 24, 2013
• Last updated: July 23, 2014
• Start date: October 2011
• Est. completion date: May 2013

Study information

• Verified date: January 2013
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Chronic Kidney Disease
• Iron Deficiency Anemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• gluconate iron
FERLIXIT fl 15mg/kg divided into weekly administrations of 125mg up to a maximum of 1000mg
• Liposomal iron
Sideral forte 30 mg/die

Locations

Country	Name	City	State
Italy	Federico II University	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modification in hemoglobin levels		3 months	No