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

Carol Davila University of Medicine and Pharmacy

Status and phase: Active, not recruiting; Phase 4

Conditions: Endothelial Dysfunction; Iron Toxicity; Renal Anemia; Oxidative Stress

Treatments: Drug: Sodium Chloride 0.9% Intravenous Solution; Drug: Ferinject

Study type: Interventional

Funder types: Other

Identifiers

NCT03388385

10488/19.04.2016

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Intervention: 250 mL Sodium Chloride 0.9% Intravenous Solution, representing control infusion, over 30 minutes.

Treatment:

Drug: Ferinject

Drug: Sodium Chloride 0.9% Intravenous Solution

Ferric carboxymaltose

Active Comparator group

Description:

Intervention: 1000 mg Ferinject in 250 mL 0.9%NaCl, representing medication in study infusion, over 30 minutes.

Treatment:

Drug: Ferinject

Drug: Sodium Chloride 0.9% Intravenous Solution