Status:
UNKNOWN
Acute Effects of Intravenous Iron on Oxidative Stress and Endothelial Dysfunction in Non-dialysis CKD
Lead Sponsor:
Carol Davila University of Medicine and Pharmacy
Collaborating Sponsors:
S.C. Sanador S.R.L
Conditions:
Renal Anemia
Iron Toxicity
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03388385
Start Date
September 20 2017
End Date
December 20 2022
Last Update
August 16 2022
Active Locations (1)
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1
"Dr. Carol Davila" Teaching Hospital of Nephrology
Bucharest, Romania