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

Sponsor
Carol Davila University of Medicine and Pharmacy (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03388385
Collaborator
S.C. Sanador S.R.L (Other)
40
Enrollment
1
Location
2
Arms
63
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 20, 2017
Actual Primary Completion Date :
Dec 30, 2020
Anticipated Study Completion Date :
Dec 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

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

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

    		•
    Active Comparator: Ferric carboxymaltose

    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
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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 Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 "Dr. Carol Davila" Teaching Hospital of Nephrology Bucharest Romania

    Sponsors and Collaborators

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

    Investigators

    • Study Chair: Gabriel Mircescu, Professor, Carol Davila University of Medicine and Pharmacy
    • Study Director: Cristina Capusa, Assoc. Prof., Carol Davila University of Medicine and Pharmacy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ana-Maria Mehedinti, Teaching Assistent, Carol Davila University of Medicine and Pharmacy
    ClinicalTrials.gov Identifier:
    NCT03388385
    Other Study ID Numbers:
    • 10488/19.04.2016
    First Posted:
    Jan 3, 2018
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Ana-Maria Mehedinti, Teaching Assistent, Carol Davila University of Medicine and Pharmacy
    CKD, anemia, iron, endothelial dysfunction, oxidative stress
    Additional relevant MeSH terms:
    Anemia

    Study Results

    No Results Posted as of Aug 16, 2022