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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03388385

Enrollment

Registered

2018-01-03

Start date

2017-09-20

Completion date

2022-12-20

Last updated

2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction, Iron Toxicity, Oxidative Stress, Renal Anemia

Keywords

CKD, anemia, iron, endothelial dysfunction, oxidative stress

Brief 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.

Interventions

DRUGSodium Chloride 0.9% Intravenous Solution

Physiologic saline infusion will be infused in day 1.

DRUGFerinject

Ferric carboxymaltose will be infused in day 2.

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Effect on endothelial function	through study completion, an average of 1 year	Description of the endothelial function variation (changing in flow-mediated vasodilatation (FMD) endothelium-dependent, and also in serum sICAM-1, sVCAM-1 and nitric oxide metabolism parameters ) after administration of a single intravenous dose of iron versus a control solution, in CKD non-dialysis patients.
Oxidative stress	through study completion, an average of 1 year	Description of some free radicals production's markers (lipid peroxidation and carbonyl stress assessment) and in antioxidant system in plasma markers variation after administration of a single intravenous iron dose versus a control solution, in non-dialysis CKD subjects.

Secondary

Measure	Time frame	Description
Correlation between endothelial dysfunction and oxidative stress markers	through study completion, an average of 1 year	Evaluation of correlations between changes in oxidative stress parameters and endothelial function after a single intravenous iron administration compared to a control solution in non-dialysis CKD subjects.

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026