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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03388385
Recruitment Status : Active, not recruiting
First Posted : January 3, 2018
Last Update Posted : August 16, 2022
Sponsor:
Collaborator:
S.C. Sanador S.R.L
Information provided by (Responsible Party):
Ana-Maria Mehedinti, Carol Davila University of Medicine and Pharmacy

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
Renal Anemia Iron Toxicity Oxidative Stress Endothelial Dysfunction Drug: Sodium Chloride 0.9% Intravenous Solution Drug: Ferinject Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : September 20, 2017
Actual Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 20, 2022


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 Name: Physiologic saline

Drug: Ferinject
Ferric carboxymaltose will be infused in day 2.
Other Name: 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 Name: Physiologic saline

Drug: Ferinject
Ferric carboxymaltose will be infused in day 2.
Other Name: Ferric carboxymaltose




Primary Outcome Measures :
  1. Effect on endothelial function [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388385


Locations
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Romania
"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
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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
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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: January 3, 2018    Key Record Dates
Last Update Posted: August 16, 2022
Last Verified: August 2022

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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, Carol Davila University of Medicine and Pharmacy:
CKD, anemia, iron, endothelial dysfunction, oxidative stress
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases