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Endovenous Versus Liposomal Iron in CKD

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ClinicalTrials.gov Identifier: NCT01864161
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Eleonora Riccio, Federico II University

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
Iron Deficiency Anemia Chronic Kidney Disease Drug: gluconate iron Drug: Liposomal iron Phase 4

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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 Name: 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 Name: FERLIXIT




Primary Outcome Measures :
  1. modification in hemoglobin levels [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864161


Locations
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Italy
Federico II University
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University

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Responsible Party: Eleonora Riccio, MD, Federico II University
ClinicalTrials.gov Identifier: NCT01864161    
Other Study ID Numbers: BIANCA79
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: January 2013
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia, Iron-Deficiency
Urologic Diseases
Renal Insufficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs