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

Oxidative Stress Clinical Trial

Official title:

The Effects of a Single Intravenous Iron Upon Vascular Endothelium and Some Parameters of Oxidative Stress in Patients With Non-dialysis Chronic Kidney Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03388385
• Other study ID #: 10488/19.04.2016
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 20, 2017
• Est. completion date: December 20, 2022

Study information

• Verified date: August 2022
• Source: Carol Davila University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 20, 2022
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Endothelial Dysfunction
• Iron Toxicity
• Oxidative Stress
• Renal Anemia

Intervention

Drug:
• Sodium Chloride 0.9% Intravenous Solution
Physiologic saline infusion will be infused in day 1.
• Ferinject
Ferric carboxymaltose will be infused in day 2.

Locations

Country	Name	City	State
Romania	"Dr. Carol Davila" Teaching Hospital of Nephrology	Bucharest

Sponsors (2)

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

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on endothelial function	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.	through study completion, an average of 1 year
Primary	Oxidative stress	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.	through study completion, an average of 1 year
Secondary	Correlation between endothelial dysfunction and oxidative stress markers	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.	through study completion, an average of 1 year