Trial | NCT03388385  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    40
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.
Study Started
Sep 20
2017
Primary Completion
Dec 30
2020
Study Completion
Dec 20
2022
Anticipated
Last Update
Aug 16
2022

Drug Sodium Chloride 0.9% Intravenous Solution

Physiologic saline infusion will be infused in day 1.

  • Other names: Physiologic saline

Drug Ferinject

Ferric carboxymaltose will be infused in day 2.

  • Other names: Ferric carboxymaltose

Placebo Placebo Comparator

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

Ferric carboxymaltose Active Comparator

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

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.
No Results Posted