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Endovenous Versus Liposomal Iron in CKD

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01864161
Enrollment
100
Registered
2013-05-29
Start date
2011-10-31
Completion date
2013-05-31
Last updated
2014-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Iron Deficiency Anemia

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.

Interventions

DRUGgluconate iron

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

Sideral forte 30 mg/die

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
modification in hemoglobin levels3 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026