Acute Effects of Intravenous Iron on Oxidative Stress and Endothelial Dysfunction in Non-dialysis CKD

• Status: Active, not recruiting
• Trial end date: 2021-12-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carol Davila University of Medicine and Pharmacy
• Collaborator: S.C. Sanador S.R.L

Criteria

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.