| Trial ID: | L1677 |
| Source ID: | NCT03388385
|
| Associated Drug: |
Sodium Chloride 0.9% Intravenous Solution
|
| Title: |
Acute Effects of Intravenous Iron on Oxidative Stress and Endothelial Dysfunction in Non-dialysis CKD
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Anemia|Iron Toxicity|Oxidative Stress|Endothelial Dysfunction
|
| Interventions: |
DRUG: Sodium Chloride 0.9% Intravenous Solution|DRUG: Ferinject
|
| Outcome Measures: |
Primary: 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: 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
|
| Sponsor/Collaborators: |
Sponsor: Carol Davila University of Medicine and Pharmacy | Collaborators: S.C. Sanador S.R.L
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2017-09-20
|
| Completion Date: |
2022-12-20
|
| Results First Posted: |
|
| Last Update Posted: |
2022-08-16
|
| Locations: |
"Dr. Carol Davila" Teaching Hospital of Nephrology, Bucharest, Romania
|
| URL: |
https://clinicaltrials.gov/show/NCT03388385
|
