Endovenous Versus Liposomal Iron in CKD

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.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Federico II University

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

gluconate iron

Drug

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

Other names: FERLIXIT

Liposomal iron

Drug

Sideral forte 30 mg/die

Other names: Sideral forte

Primary outcomes

modification in hemoglobin levels

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: May 29, 2013
Registry last updated: Jul 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed