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Ferric carboxymaltose (FCM) is a nanomedicine that has a similar structure to serum ferritin, which allows a controlled delivery of iron into the reticuloendothelial system and subsequently, onto the transport or deposit proteins. Therefore, the potential to produce oxidative stress by releasing "free" iron seems small, but has been incomplete investigated. The impact of FCM on oxidative stress is even less studied in patients with chronic kidney disease (CKD). Therefore, we assessed the effect of a single dose of 1000mg FCM on oxidative stress in non-dialysis CKD subjects with iron deficiency and anemia.
In this prospective crossover study, we enrolled 41 non-dialysis patients in G3-G5 CKD risk category, median age 68 (58-70), 61% women, 90% with hypertension and 41% diabetes, with iron deficiency and anemia. Control-infusion (250ml 0.9%NaCl) and the intervention (1000mg FCM in 250ml 0.9%NaCl), were administrated at 24 hours interval, in this order, intravenously, during 30 minutes. Before and after each of the infusions, blood samples were collected at 0 minutes, 30 minutes, 6 hours and 24 hours. Total antioxidant capacity of serum (TACS) was measured. Advanced oxidation protein products (AOPP) were analyzed for 22 patients. The interest parameters and their variation were compared before and after the intervention, and the control perfusion, respectively. The non-parametric Kruskal-Wallis and Wilcoxon signed rank sum tests were used for the analysis.
Ferric carboxymaltose did not influence the total antioxidant capacity of serum at any study moment when compared with control-infusion. Advanced oxidation protein products level increased after FCM in comparison with 0.9%NaCl perfusion, at each of the study moments. The increase continued at 6 hours, only to decrease after 24 hours, but without returning to the basal level.
A single 1000mg dose of ferric carboxymaltose increases AOPP levels, but does not influence the total antioxidant capacity of the serum, in CKD patients in G3-G5 risk category, with iron deficiency and anemia.