Status:
COMPLETED
Endovenous Versus Liposomal Iron in CKD
Lead Sponsor:
Federico II University
Conditions:
Iron Deficiency Anemia
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01864161
Start Date
October 1 2011
End Date
May 1 2013
Last Update
July 24 2014
Active Locations (1)
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1
Federico II University
Naples, Naples, Italy, 80131