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

NCT03388385 | Unknown Phase 4

• 1 other identifier: 10488/19.04.2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Anemia; Iron Toxicity; Oxidative Stress; Endothelial Dysfunction

Keywords

CKD, anemia, iron, endothelial dysfunction, oxidative stress

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Correlation between endothelial dysfunction and oxidative stress markers

  through study completion, an average of 1 year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

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

Ferric carboxymaltose

ACTIVE COMPARATOR

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

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

Interventions

Sodium Chloride 0.9% Intravenous Solution DRUG

Physiologic saline infusion will be infused in day 1.

Also known as: Physiologic saline

Ferric carboxymaltose; Placebo

Ferinject DRUG

Ferric carboxymaltose will be infused in day 2.

Also known as: Ferric carboxymaltose

Ferric carboxymaltose; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead
• S.C. Sanador S.R.L: collaborator

Study Sites (1)

"Dr. Carol Davila" Teaching Hospital of Nephrology

Bucharest, Romania

Location

MeSH Terms

Conditions

Anemia

Interventions

Sodium Chloride; ferric carboxymaltose

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Gabriel Mircescu, Professor

  Carol Davila University of Medicine and Pharmacy

  STUDY CHAIR

• Cristina Capusa, Assoc. Prof.

  Carol Davila University of Medicine and Pharmacy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistent

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 3, 2018
• Study Start: September 20, 2017
• Primary Completion: December 30, 2020
• Study Completion: December 20, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

RO (1)