Clinical trial NCT03388385: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Renal Anemia
Iron Toxicity
Oxidative Stress
Endothelial Dysfunction
Keywords: CKD, anemia, iron, endothelial dysfunction, oxidative stress
Lead sponsor: Carol Davila University of Medicine and Pharmacy
Sponsor class: OTHER
Collaborators: name: S.C. Sanador S.R.L
First posted: 2018-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Effect on endothelial function
timeFrame: through study completion, an average of 1 year
measure: Oxidative stress
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Correlation between endothelial dysfunction and oxidative stress markers
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: "Dr. Carol Davila" Teaching Hospital of Nephrology
Study officials:
affiliation: Carol Davila University of Medicine and Pharmacy
name: Gabriel Mircescu, Professor
role: STUDY_CHAIR
affiliation: Carol Davila University of Medicine and Pharmacy
name: Cristina Capusa, Assoc. Prof.
role: STUDY_DIRECTOR
References: