Acute Effects of Intravenous Iron on Oxidative Stress and Endothelial Dysfunction in Non-dialysis CKD
The Effects of a Single Intravenous Iron Upon Vascular Endothelium and Some Parameters of Oxidative Stress in Patients With Non-dialysis Chronic Kidney Disease
Lead SponsorCarol Davila University of Medicine and Pharmacy
StatusActive, not recruiting
Indication/ConditionRenal Anemia Iron Toxicity Oxidative Stress Endothelial Dysfunction
Intervention/TreatmentSodium Chloride 0.9% Intravenous Solution Ferinject
The purpose of this study is to investigate the effects of acute intravenous iron administration on the endothelial function in non-dialysis Chronic Kidney Disease stages G3-G5 patients with anemia and iron deficiency, in relation to changes in oxidative and nitrosative status.
Physiologic saline infusion will be infused in day 1.
Ferric carboxymaltose will be infused in day 2.
Intervention: 250 mL Sodium Chloride 0.9% Intravenous Solution, representing control infusion, over 30 minutes.
Intervention: 1000 mg Ferinject in 250 mL 0.9%NaCl, representing medication in study infusion, over 30 minutes.
Inclusion Criteria: Chronic kidney disease stages G3-G5 (defined according to KDIGO criteria); Anemia (defined according to KDIGO criteria) and iron deficiency defined as serum ferritin < 100 ng/mL and/or TSAT < 20% (KDIGO). Exclusion Criteria: contraindications of intravenous iron therapy: iron allergy, active infection, hemochromatosis, iron overload (serum ferritin > 500 ng/mL and/or transferrin saturation > 50%); treatment with iron and erythropoiesis-stimulating agents (at the time of recruitment and 6 months previously); active smoker status; antioxidant food supplements treatment in the last 3 months; clinically manifest bleeding; another cause of anemia (hemoglobinopathies, vitamin B12 and/or folic acid deficiency suggested by the megaloblastic peripheral blood smears's appearance, multiple myeloma and other paraproteinemias); severe anemia (Hb < 7 g/dl); baseline FMD < 7% (the existence of atherosclerosis which limits arterial reactivity); cancer (currently or in the past 6 months); hepatopathies (increased serum transaminases ≥ 3 x normal value) or hepatic impairment ≥ grade Child B; autoimmune disorders or significant inflammation (as defined by C-reactive protein > 5 mg/L); pregnancy or lactation; participation in other clinical trials over the upast 3 months; patient unwillingness.