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Endovenous Versus Liposomal Iron in CKD

Sponsor
Federico II University (Other)
Overall Status
Completed
CT.gov ID
NCT01864161
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
19
Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: gluconate iron
  • Drug: Liposomal iron
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. modification in hemoglobin levels [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Federico II University Naples Italy 80131

    Sponsors and Collaborators

    • Federico II University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eleonora Riccio, MD, Federico II University
    ClinicalTrials.gov Identifier:
    NCT01864161
    Other Study ID Numbers:
    • BIANCA79
    First Posted:
    May 29, 2013
    Last Update Posted:
    Jul 24, 2014
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Anemia, Iron-Deficiency
    Iron

    Study Results

    No Results Posted as of Jul 24, 2014