Endovenous Versus Liposomal Iron in CKD

NCT01864161 | Completed Phase 4 DMC

• 1 other identifier: BIANCA79
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• modification in hemoglobin levels

  3 months

Study Arms (2)

oral liposomal iron

EXPERIMENTAL

patients receive a dose of liposomal 30 mg/die iron (equivalent to 1 cp Sideral forte).

Drug: Liposomal iron

endovenous iron

ACTIVE COMPARATOR

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

Interventions

gluconate iron DRUG

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

Also known as: FERLIXIT

endovenous iron

Liposomal iron DRUG

Sideral forte 30 mg/die

Also known as: Sideral forte

oral liposomal iron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University

Naples, Naples, 80131, Italy

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Renal Insufficiency, Chronic

Interventions

ferlixit

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: May 29, 2013
• Study Start: October 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 24, 2014

Record last verified: 2013-01

Locations

IT (1)