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| Name | Class |
|---|---|
| S.C. Sanador S.R.L | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Intervention: 250 mL Sodium Chloride 0.9% Intravenous Solution, representing control infusion, over 30 minutes. |
|
| Ferric carboxymaltose | Active Comparator | Intervention: 1000 mg Ferinject in 250 mL 0.9%NaCl, representing medication in study infusion, over 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Chloride 0.9% Intravenous Solution | Drug | Physiologic saline infusion will be infused in day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Dr. Carol Davila" Teaching Hospital of Nephrology | Bucharest | Romania |
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| Ferinject | Drug | Ferric carboxymaltose will be infused in day 2. |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| C522335 | ferric carboxymaltose |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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