High-dose Iron Research Articles

Comparison of the efficacy and safety between high-dose intravenous iron and oral iron in treating iron deficiency anemia: a multicenter, prospective, open-label, randomized controlled study

Objective: This study aimed to compare the efficacy and safety between high-dose intravenous iron and oral iron in treating iron deficiency anemia (IDA) . Methods: This prospective randomized controlled study (1∶1) enrolled 338 patients with IDA at The First Affiliated Hospital of Soochow University, Suzhou Hongci Hematology Hospital, and Huai'an Second People's Hospital from June 1, 2022, to January 19, 2024. Of all the patients, 169 received high-dose intravenous iron therapy and 169 received oral iron treatment for 12 weeks of observation. Focus on the hemoglobin (HGB) change from baseline to week 4, secondary focus was on the HGB and iron metabolism parameters (serum iron [SI], transferrin saturation [TSAT], total iron binding force [TIBC], serum ferritin [SF]), and changes in the fatigue score, efficacy, and treatment-related adverse effects were monitored throughout in the two treatment groups. Results: The HGB levels were improved in both treatments, but the HGB improved faster in the intravenous group compared with the oral group. HGB increased from (76.8±15.0) g/L to (118.0±13.3) g/L in the intravenous group and from (77.9±11.6) g/L to (104.3±15.0) g/L in the oral group after 4 weeks of treatment. The increase from baseline in the intravenous group (40.7±17.3) g/L was significantly higher than that in the oral group (27.2±17.5) g/L (P<0.001). The intravenous group demonstrated a more significant early effect than the oral group in terms of iron metabolism parameter improvement. SI, TSAT, TBIC, and SF increased better from baseline at 4 weeks in the intravenous group than in the oral group (P<0.001). Additionally, the intravenous group exhibited better fatigue scores for early improvement than the oral group (P<0.001). The incidence of total adverse effects was similar in the intravenous group as compared to the oral group (3.5% [6/169] vs 5.9% [10/169], P=0.442) . Conclusion: High doses of intravenous iron quickly boost HGB early, causing rapid improvement in SI, TSAT, TBIC, SF, and patient fatigue scores. The patient was well tolerated.

Hippocampal iron overload and spatial reference memory impairment: Insights from a rat model

BackgroundBrain iron overload may induce neuronal death and lead to cognitive impairment. The hippocampus is a critical limbic structure involved in memory. This study aimed to investigate iron overload and its role in hippocampal damage and memory impairment using a rat model. MethodsYoung rats (2 weeks old) received intraperitoneal injections of high-dose iron solution (Group H, n = 10), low-dose iron solution (Group L, n = 10) and normal saline as control (Group D, n = 5). The Morris water maze (MWM) test was performed on all rats to evaluate their spatial reference memory by assessing their escape latency time and number of platform crossing. The iron content and neuronal damage in hippocampal tissue sections of the rats were assessed semi-quantitatively using diaminobenzidine (DAB)-enhanced Perl’s Prussian blue (PPB) staining, and their correlation with spatial reference memory performance was evaluated. ResultsThe escape latency in Group H was significantly longer compared to Groups L and D (P < 0.05). The number of platform crossings was significantly lower in Group H than in Group L or D (P < 0.001). The neuronal cells in Group H had more brown iron deposits than those of Groups L and D. There were significant correlations between the severity of structural damage in the hippocampal tissue and the number of platform crossings (P1 = 0.001 for Group H; P2 = 0.043 for Group L). ConclusionThis study showed an association between hippocampal iron-induced structural damage and spatial reference memory impairment in a rat model. This work should advance our understanding of hippocampal iron overload on cognitive functioning.

Creatine Supplementation Increases Iron Absorption From High Dose Iron in Healthy but Not Iron Deficient Caco-2 Cells

Creatine Supplementation Increases Iron Absorption From High Dose Iron in Healthy but Not Iron Deficient Caco-2 Cells

Low-Dose Iron is Safer, Tolerable and Equally Effective to High-Dose Iron in Improving Iron Status in Mild-Anemic Female Participants

Low-Dose Iron is Safer, Tolerable and Equally Effective to High-Dose Iron in Improving Iron Status in Mild-Anemic Female Participants

Dose-Responsive Effects of Iron Supplementation on the Gut Microbiota in Middle-Aged Women.

Oral iron supplementation is the first-line treatment for addressing iron deficiency, a concern particularly relevant to women who are susceptible to sub-optimal iron levels. Nevertheless, the impact of iron supplementation on the gut microbiota of middle-aged women remains unclear. To investigate the association between iron supplementation and the gut microbiota, healthy females aged 40-65 years (n = 56, BMI = 23 ± 2.6 kg/m2) were retrospectively analyzed from the Alberta's Tomorrow Project. Fecal samples along with various lifestyle, diet, and health questionnaires were obtained. The gut microbiota was assessed by 16S rRNA sequencing. Individuals were matched by age and BMI and classified as either taking no iron supplement, a low-dose iron supplement (6-10 mg iron/day), or high-dose iron (>100 mg/day). Compositional and functional analyses of microbiome data in relation to iron supplementation were investigated using various bioinformatics tools. Results revealed that iron supplementation had a dose-dependent effect on microbial communities. Elevated iron intake (>100 mg) was associated with an augmentation of Proteobacteria and a reduction in various taxa, including Akkermansia, Butyricicoccus, Verrucomicrobia, Ruminococcus, Alistipes, and Faecalibacterium. Metagenomic prediction further suggested the upregulation of iron acquisition and siderophore biosynthesis following high iron intake. In conclusion, adequate iron levels are essential for the overall health and wellbeing of women through their various life stages. Our findings offer insights into the complex relationships between iron supplementation and the gut microbiota in middle-aged women and underscore the significance of iron dosage in maintaining optimal gut health.

Iron Supplementation May Improve the Patient's Level of Satisfaction in Not-Low-Ferritin Telogen Effluvium: A Real-Life Observational Study.

Telogen effluvium (TE) is the most common cause of alopecia in women. Treatment should address the etiological factors and may include adjuvant therapies. In practice, physicians may employ modified approaches and utilize various combinations of topical and oral molecules. In this real-life observational study, the aim was to evaluate the response of TE to iron supplementation. The population consisted of all patients who sought consultation for TE at our dermatology department between March 2021 and February 2022. Eligible participants were women, aged between 18 and 65, having a clinical diagnosis of TE, and intended for treatment with iron supplementation. Exclusion criteria comprised current pregnancy, chronic or active inflammatory disease, newly discovered dysthyroidism, concurrent use of hair supplements, topical minoxidil, or any other medications. The response was assessed based on the patient's level of satisfaction, a significant indicator, given the substantial psychological impact of TE on women's daily lives. The analysis included 200 women. The average age was 32.9 ± 11.4 years. A recent history of COVID-19 or treated dysthyroidism was present in 18.5% and 8% of patients, respectively, but did not impact their response. Significantly, patients with baseline ferritin ≥50 ng/ml were mostly "very satisfied", those with baseline ferritin <50 ng/ml were mostly "not satisfied", and those with unknown levels were mostly "partially satisfied" with iron supplementation. A high dose of elemental iron and a prolonged duration of treatment significantly improved the patients' level of satisfaction. Iron supplementation can improve the patient's level of satisfaction in TE even if serum ferritin is not low.

P-17 Hypophosphatemia related to intravenous iron therapy: A case report

Abstract Introduction Intravenous iron supplementation is a good alternative to oral iron replacement in iron deficiency anaemia. Intravenous iron formulations such as ferric carboxymaltose allow administration of high doses of elemental iron and enable correction of total iron deficit in one or two infusions. An important complication of ferric carboxymaltose is hypophosphatemia caused by increased secretion of the phosphaturic hormone, fibroblast growth factor 23 (FGF23). In this case, we aimed to present our patient with this rare side effect of intravenous iron replacement. Clinical Case A 40-year-old female patient who has no chronic systemic disease was admitted to our endocrinology service for fatigue and weakness. In the patient's history, it was learned that she had been treated with 2500 mg intravenous iron replacement (ferric carboxymaltose) for iron deficiency anaemia in the last month. In the laboratory tests; serum phosphorus 1.05 mg/dl (normal 2.5-4.5 mg/dl), corrected calcium 8.45 mg/dl (normal 8.4-10.2 mg/dl), 25-OH vitamin D 31.4 µg/L (normal &amp;gt;30 µg/L), parathormone 83.2 pg/ml (normal 15-65 ng/ml), alkaline phosphatase 63 U/L (normal 35-105 U/L). Fractional excretion of phosphate (FePO4) confirmed renal phosphate wasting (FePO4: 28.6%; normal &amp;lt;5%). Urinary protein and glucose were negative. FGF23 measured 71 pg/ml (normal &amp;lt;59 pg/mL). Intravenous iron-induced hypophosphataemia was suspected. After initiation of oral phosphate and 1,25-dihydroxyvitamin D3 supplementation, serum phosphate rose to reference range (Figure 1). The patient was taken to outpatient follow-up. Conclusion Physicians should be aware of hypophosphatemia as a common complication of intravenous iron therapy and monitor serum phosphate concentrations in patients receiving repeated doses.Figure 1.Patient phosphorus data during follow-up

Advancing Patient Blood Management: Evaluation of Ferric Derisomaltose in a Tertiary Hospital

ABSTRACT Background and Objectives: One of the aims of patient blood management (PBM) programs is to improve patient outcomes by managing anemia and avoiding unnecessary blood transfusions. Ferric derisomaltose (FDI) is a treatment that allows for the injection of high doses of iron in a shorter time, which makes it a promising approach for correcting iron-deficiency anemia (IDA) more efficiently. This study aimed to assess the safety, effectiveness, and cost implications of FDI in a PBM program and its impact on transfusion requirements. Methods: A retrospective analysis was conducted on electronic medical records of adult patients diagnosed with IDA who received FDI as part of a PBM strategy in a tertiary hospital from November 2019 to June 2021. Descriptive statistics summarized patient characteristics and outcomes. Changes in hemoglobin (Hb) levels were evaluated using a paired t-test. Cost analysis included direct and indirect expenses associated with FDI administration compared to alternative treatments. Results: Out of the initially enrolled 110 patients, 67 were included in the analysis. A mean increase in Hb levels of 2.7 ± 1.9 g/dL was observed as early as 4 days post-FDI administration. The majority of patients (94.0%) tolerated FDI well, with only a few experiencing mild adverse reactions. Following FDI administration, blood transfusion was avoided by 88% of patients. Cost analysis revealed that while FDI demonstrated higher direct costs compared to alternative treatments, its potential for lower total costs became apparent when considering both direct and indirect expenses. Conclusions: FDI demonstrated promising results in rapidly correcting IDA within a PBM program. It reduced the need for blood transfusions, with the treatment being well-tolerated by patients. The inclusion of FDI administration in PBM programs offers a convenient, efficient, and potentially cost-effective approach to managing IDA.

Evaluation of the effectiveness of the use of iron carboxymaltosate in late pregnancy and in the postpartum period

Objective: to evaluate the effectiveness of the use of iron carboxymaltosate in late pregnancy and in the postpartum period. Materials and methods: dynamic observation of the effectiveness of iron carboxymaltosate in 46 pregnant women diagnosed with anemia, latent iron deficiency due to the lack of positive dynamics against the background of taking oral forms of iron preparations, complaining of palpitations, shortness of breath with minimal physical exertion, weakness. The assessment was carried out by the level of hemoglobin (Hb), ferritin a month after the treatment with a high-dose iron preparation intravenously drip. The follow–up period is the third trimester of pregnancy, 2 days after delivery, a month after delivery. Results: the treatment with iron of carboxymaltosate led to an increase in the Hb level of 18±3 g/l, the ferritin level of 70±35 mcg/l a month after the infusion, and an improvement in the clinical condition. Conclusion: the use of iron carboxymaltose in the late stages of pregnancy allows to quickly normalize and maintain target values of hemoglobin and ferritin levels for a long time, already during the postpartum period, as well as improve the quality of life of women.

Budget Impact Analysis of Ferric Derisomaltose for the Treatment of Iron-Deficiency in Malaysia

Introduction: Untreated iron deficiency (ID) can lead to severe anaemia, requiring blood transfusion, or increased mortality risk. Globally intravenous (IV) iron is increasingly recognised as a recommended option for patients. This study aims to evaluate the budget impact associated with introducing a new intravenous (IV) iron, ferric derisomaltose (Monofer® [IIM]) as one of the treatment options for the management of ID in the Ministry of Health Malaysia (MOHM) setting. Methods: A 5-year budget impact model was developed from 2020 to 2024 for patients with ID that require a high iron dose (≥500 mg), using the perspective of MOHM. The model was built with four external medical specialists, each with experience and deep knowledge of ID management, to support estimations on the future development of iron use in Malaysia. Results: Compared to the current market mix with the existing IV iron products (i.e., iron sucrose and iron dextran), a cost-saving of MYR 53,910 could be achieved with the introduction of IIM in 2020. The uptake of IIM into MOHM over five years is estimated to lead to an overall budget saving of MYR 11,837,524 over a 5-year time horizon. Conclusion: The use of IIM in place of the current IV iron products in MOHM resulted in a significant cost saving by reducing the number of visits required to achieve the targeted iron dose and the shorter IV infusion time with IIM.

The treatment effects and cardiovascular events of high-dose intravenous iron for hemodialysis patients with renal anemia: A systematic review and meta-analysis.

Hemodialysis patients are common to have renal anemia in the nephrology practice. For the renal anemia, the high-dose iron from the intravenous route is an important treatment option. We can understand the treatment effects and cardiovascular events of high-dose intravenous iron reviewing the randomized clinical trials. We compared the high-dose and low-dose iron treatments to find if the high-dose intravenous iron can influence the hematological parameters more significantly than the low-dose iron. The cardiovascular events were also analyzed for the high-dose iron treatment. Six studies with a total of 2422 renal anemia patients under hemodialysis were enrolled. We focused the outcomes of hemoglobin, transferrin saturation percentage, ferritin, erythropoietin dose, and cardiovascular events. The high-dose intravenous iron might be associated with a greater number of ferritin, transferrin saturation percentage, and hemoglobin. In addition, the erythropoietin dose was less needed to maintain the ideal hemoglobin range in the high-dose intravenous iron group. In current meta-analysis, the high-dose intravenous iron might show the superior effects on the ferritin, transferrin saturation percentage, and hemoglobin levels and needed dose of erythropoietin when compared to low-dose iron treatment.

Financial burden associated with discordance to intravenous iron therapies in US patients with iron deficiency anemia.

BACKGROUND: Iron deficiency anemia (IDA) affects approximately 5 million people in the United States and has a significant impact on human health. Intravenous (IV) iron is indicated for treatment of IDA when oral iron is not effective or not tolerated. Several IV iron products are available, including oldergeneration and newer-generation products. Newer agents have certain benefits, including the ability to administer high iron doses in fewer infusions; despite the benefits, some payors require failure on older iron products before use of newer iron products in prior authorization processes. IV iron replacement regimens requiring multiple infusions may lead to patients not receiving recommended IV iron treatment per label; potential costs of this discordance may outweigh the difference in price between the older and newer products. OBJECTIVE: To quantify the burden of discordance to IV iron therapy and associated economic consequences. METHODS: This is a retrospective study using administrative claims data between January 2016 and December 2019 from adult patients who are enrolled in a commercial insurance program with a regional health plan. A course of IV iron therapy is defined as all infusions that occur within 6 weeks of the initial infusion. Discordance to therapy is defined as having received less than 1,000 mg of iron over a course of therapy. RESULTS: There were 24,736 patients included in the study. Baseline demographics were similar between the patients who received older- vs newer-generation products and patients who were concordant vs discordant. Discordance to IV iron therapy overall was 33%. Patients who received newer-generation products were less discordant to therapy (16%) than patients who received older-generation products (55%). In general, patients who received newer-generation products had a lower total cost of care than patients who received older-generation products. CONCLUSIONS: Discordance to the older-generation products was significantly higher than that to the newer-generation products. Patients who were concordant to therapy and on a newer-generation product had the lowest total cost of care, suggesting that overall cost of care is not necessarily proportional to the purchase price of the chosen IV iron replacement therapy. Optimizing concordance to IV iron therapy may lead to lower total cost of care in the IDA population. DISCLOSURES: Magellan Rx Management received funding for this study from Pharmacosmos Therapeutics Inc. AESARA contributed to study design and data analysis. Magellan Rx Management contributed to the study design, data analysis, and interpretation of results. Pharmacosmos Therapeutics Inc. participated in the study design and interpretation of results.

A prospective randomized controlled trial evaluating the safety and efficacy of patient blood management program in patients with gynecologic cancer (KGOG 4011/PBM)

BackgroundGynecologic cancer has a high frequency of anemia, which is associated with increased morbidity and mortality. Blood transfusion is used to correct anemia, but carries its own side effects and...

Longitudinal plasma magnesium status during pregnancy and the risk of gestational diabetes mellitus: a prospective cohort study

Emerging evidence has shown that magnesium (Mg) was associated with type 2 diabetes while few focused on abnormal glucose metabolism during pregnancy. The study is aimed at investigating the association between longitudinal changes in plasma Mg during pregnancy and subsequent risk of gestational diabetes (GDM) and exploring the possible influence of iron supplementation on the changes of plasma Mg levels. One thousand seven hundred fifty-six pregnant women from Tongji Maternal and Child Health Cohort (TMCHC) were involved. Blood samples were collected at gestational weeks 17.0 ± 0.9 and later 26.2 ± 1.4. Plasma Mg was measured by inductively coupled plasma mass spectrometry (ICP-MS) with decline rates calculated. Information on general characteristics and iron supplementation was collected by questionnaires. Oral glucose tolerance test (OGTT) was conducted at 24-28 gestational weeks to diagnose GDM. Poisson regression with robust error variance was used to estimate relative risks (RR) of GDM. Median concentrations of plasma Mg were 0.69mmol/L and 0.63mmol/L respectively at two collections. The prevalence of hypomagnesemia at the first collection was 73% and associated with a 1.59 (95%CI: 1.07, 2.37) fold risk of GDM. Adjusted RRs were 1.74 (95%CI: 1.06, 2.83) and 2.44 (95%CI: 1.54, 3.85) for women with hypomagnesemia and followed more tertile (T2 and T3 vs. T1) of Mg decrement. Iron supplementation above 30mg/day was found associated with more Mg decrement (25.5% and 27.5% in T2 and T3 vs. 19.5% in T1). In conclusion, hypomagnesemia during pregnancy is prevalent and associated with increased GDM risk, especially in women followed by more plasma Mg decrement during pregnancy. High-dose iron supplementation may involve more plasma Mg decrement.

The Effect of High Dosage of Iron Supplementation (Fe) Against Histopathology of Gastric Mucosa in Pregnant Strain Wistar White Rats (Rattus norvegicus)

Pregnant women are encouraged to consume iron tablets during their pregnancy or at least 90 tablets during pregnancy. Side effects of iron tablets include nausea, vomiting, diarrhea, constipation. If the tablets is consumed in excess it will cause toxicity because excess iron will cause oxidative stress which can affect the state of the stomach. Purpose: to determine the effect of high-dose iron (Fe) supplementation on the histopathology of gastric mucosa in pregnant strain Wistar white rats (Rattus norvegicus). This study used 24 pregnant rats divided into 4 groups, that is, negative controls; treatment 1 with a dose of 0.54 mg; treatment 2 with a dose of 1.08 mg; and treatment 3 with a dose of 2.16 mg. Iron (Fe) supplementation was started from the 1st day of pregnancy until the 18th day, then on the 19th day the rats were dissected and the gastric organ was taken as a preparation with Hematoxylin Eosin (HE) staining and then observed with a light microscope. This study showed the histopathological results of gastric mucosa damaged in the treatment group which was assessed using the Barthel Manja score. The One Way ANOVA test results showed a significant difference from gastric mucosa (p = 0.000) in the control and treatment groups of this study. High doses of iron (Fe) supplementation affect the histopathology of gastric mucosa.

Dosing of iron supplementation for iron-deficient patients with heart failure: should we prefer more intensive or less intensive repletion targets?

Dosing of iron supplementation for iron-deficient patients with heart failure: should we prefer more intensive or less intensive repletion targets?

Dynamic laboratory control of iron deficiency correction in neurosurgical patients

Introduction. The concept of blood management in relation to the surgical treatment of surgical diseases recommends the correction of iron defi ciency anemia (IDA) at the prehospital stage. However, surgery is often performed for emergency indications, making it necessary to carry out treatment as soon as possible.Aim – to evaluate the possibilities of using delta hemoglobin (Delta-He) to monitor the effectiveness of IDA therapy in neurosurgical patients at the prehospital stage to reduce the time required to prepare patients for hospitalization.Materials and methods. A total of 42 patients were treated with high-dose iron preparations (iron [III] carboxymaltosate and iron [III] hydroxide oligoisomaltosate). During the treatment, the dynamics of the number of reticulocytes and the values of the hemoglobin delta were evaluated. Data are presented as median (IQR).Results. Treatment with high-dose iron preparations led to an increase in Delta-He values starting from days 1–2. Significant changes were recorded by days 3–4 from the start of therapy: from 2.2 (0.3–4.9) pg to 15.5 (13.8–10) pg on day 7. These changes were 2–3 days ahead of the increase in the number of reticulocytes in the corresponding blood samples: the number of reticulocytes significantly increased by days 5–6 from the start of treatment.Conclusion. The use of high-dose preparations of iron [III] carboxymaltosate and iron [III] hydroxide oligoisomaltosate in the form of infusion made it possible to prepare neurosurgical patients for hospitalization within a week. None of the patients required transfusion of erythrocyte-containing components of donated blood at any stage of surgical treatment. The ability to focus on Delta-He values instead of the number of reticulocytes during iron therapy made it possible to shorten the waiting period for the effect of drug exposure by 2–3 days.

Ferumoxytol: an emerging therapeutic for iron deficiency anemia

ABSTRACT Introduction Iron deficiency anemia (IDA) is common worldwide, and various iron replacement therapies are available. Ferumoxytol is an injectable, high-dose iron formulation (510 mg) that can be administered over a short period (15 min) without test administration. The drug was approved by the Food and Drug Administration in 2009 for the treatment of IDA in patients with chronic kidney disease (CKD), and in 2018, the indication was expanded to include patients without CKD. Areas covered This paper reviews studies testing the efficacy and safety of ferumoxytol in treating IDA compared with other iron formulations. Expert opinion There is substantial evidence that ferumoxytol is effective for the treatment of IDA. The efficacy of ferumoxytol in improving anemia is comparable to that of iron sucrose and ferric carboxymaltose (FCM) and superior to that of oral iron or a placebo in replenishing iron stores. Treatment with ferumoxytol, although more expensive, is cost-effective for outpatients requiring parenteral administration because it requires fewer doses and shorter dosing times per dose. Ferumoxytol also causes less frequent hypophosphatemia than FCM. Currently, its use in children and pregnant women is under consideration, which may provide important information for the future applications of ferumoxytol in larger numbers of patients.

Microgreens Biometric and Fluorescence Response to Iron (Fe) Biofortification.

Microgreens are foods with high nutritional value, which can be further enhanced with biofortification. Crop biofortification involves increasing the accumulation of target nutrients in edible plant tissues through fertilization or other factors. The purpose of the present study was to evaluate the potential for biofortification of some vegetable microgreens through iron (Fe) enrichment. The effect of nutrient solution supplemented with iron chelate (1.5, 3.0 mg/L) on the plant's growth and mineral concentration of purple kohlrabi, radish, pea, and spinach microgreens was studied. Increasing the concentration of Fe in the medium increased the Fe content in the leaves of the species under study, except for radish. Significant interactions were observed between Fe and other microelements (Mn, Zn, and Cu) content in the shoots. With the increase in the intensity of supplementation with Fe, regardless of the species, the uptake of zinc and copper decreased. However, the species examined suggested that the response to Fe enrichment was species-specific. The application of Fe didn't influence plant height or fresh and dry weight. The chlorophyll content index (CCI) was different among species. With increasing fertilisation intensity, a reduction in CCI only in peas resulted. A higher dose of iron in the medium increased the fluorescence yield of spinach and pea microgreens. In conclusion, the tested species, especially spinach and pea, grown in soilless systems are good targets to produce high-quality Fe biofortified microgreens.

Safety and effectiveness of ferric carboxymaltose intravenous therapy in pediatric patients with chronic kidney disease.

Iron-deficiency anemia is the most common reason for worsening of the anemia characteristically seen in chronic kidney disease (CKD). Ferric carboxymaltose (FCM) is a macromolecular hydroxide ferric carbohydrate complex that allows high-dose iron to be administered parenterally for gradual, controlled release. The aim of this study was to retrospectively evaluate the safety and effectiveness of FCM treatment in pediatric patients with CKD non-dependent of hemodialysis, seen at a tertiary hospital. Data were collected on demographics, dosage, infusion time, laboratory results, and tolerability of the medicinal product. A total of 79 patients (40.5% girls) were included; the median age [25th percentile (P25) to 75th percentile (P75)] was 9 years (5–13). Laboratory results at 15–45 days post-infusion revealed a median increase of 1.4 g/dL (0.9–1.9) in hemoglobin, 224 μg/L (136–378.5) in ferritin, 37 μg/dL (17.5–71) in serum iron, and 18% (9.3–27.8) in transferrin saturation. All patients tolerated FCM infusions well, and no serious hypersensitivity reactions or anaphylactic reactions were observed. Only one adverse event was identified: drug extravasation at the end of the infusion in a 16-year-old patient. These data provide further evidence for the use of FCM as a safe and effective therapeutic option in pediatric patients with CKD, based on the low incidence of adverse effects, minor intervention required, and anemia improvement based on laboratory results.