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

Primary Purpose

Renal Anemia, Iron Toxicity, Oxidative Stress

Status
Active
Phase
Phase 4
Locations
Romania
Study Type
Interventional
Intervention
Sodium Chloride 0.9% Intravenous Solution
Ferinject
Sponsored by
Carol Davila University of Medicine and Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Anemia focused on measuring CKD, anemia, iron, endothelial dysfunction, oxidative stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • "Dr. Carol Davila" Teaching Hospital of Nephrology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Ferric carboxymaltose

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 18, 2017
Last Updated
August 14, 2022
Sponsor
Carol Davila University of Medicine and Pharmacy
Collaborators
S.C. Sanador S.R.L
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1. Study Identification

Unique Protocol Identification Number
NCT03388385
Brief Title
Acute Effects of Intravenous Iron on Oxidative Stress and Endothelial Dysfunction in Non-dialysis CKD
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carol Davila University of Medicine and Pharmacy
Collaborators
S.C. Sanador S.R.L

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Anemia, Iron Toxicity, Oxidative Stress, Endothelial Dysfunction
Keywords
CKD, anemia, iron, endothelial dysfunction, oxidative stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intervention: 250 mL Sodium Chloride 0.9% Intravenous Solution, representing control infusion, over 30 minutes.
Arm Title
Ferric carboxymaltose
Arm Type
Active Comparator
Arm Description
Intervention: 1000 mg Ferinject in 250 mL 0.9%NaCl, representing medication in study infusion, over 30 minutes.
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride 0.9% Intravenous Solution
Other Intervention Name(s)
Physiologic saline
Intervention Description
Physiologic saline infusion will be infused in day 1.
Intervention Type
Drug
Intervention Name(s)
Ferinject
Other Intervention Name(s)
Ferric carboxymaltose
Intervention Description
Ferric carboxymaltose will be infused in day 2.
Primary Outcome Measure Information:
Title
Effect on endothelial function
Description
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.
Time Frame
through study completion, an average of 1 year
Title
Oxidative stress
Description
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.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Correlation between endothelial dysfunction and oxidative stress markers
Description
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.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Mircescu, Professor
Organizational Affiliation
Carol Davila University of Medicine and Pharmacy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cristina Capusa, Assoc. Prof.
Organizational Affiliation
Carol Davila University of Medicine and Pharmacy
Official's Role
Study Director
Facility Information:
Facility Name
"Dr. Carol Davila" Teaching Hospital of Nephrology
City
Bucharest
Country
Romania

12. IPD Sharing Statement

Learn more about this trial

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

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