Intravenous ferric carboxymaltose versus standard medical care in the treatment of iron deficiency anemia in patients with chronic kidney disease: a randomized, active-controlled, multi-center study

AbstractIn non-dialysis-dependent chronic kidney disease (NDD-CKD), erythropoiesis-stimulating agents (ESAs) and iron supplementation are essential for anemia management. Ferric carboxymaltose (FCM) is a relatively novel intravenous iron formulation used in different clinical settings, although scarce data exist in NDD-CKD patients. Primary objective of this study was to retrospectively evaluate the efficacy of FCM compared with oral ferrous sulfate for the treatment of iron-deficiency anemia in a cohort of NDD-CKD patients, considering also the treatment costs. This was a monocentric, retrospective observational study reviewing 349 NDD-CKD patients attending an outpatient clinic between June 2013 and December 2016. Patients were treated by either FCM intravenous infusion or oral ferrous sulfate. We collected serum values of hemoglobin, ferritin and transferrin saturation (TSAT) and ESAs doses at 12 and 18 months. The costs related to both treatments were also analysed. 239 patients were treated with FCM intravenous infusion and 110 patients with oral ferrous sulfate. The two groups were not statistically different for age, BMI and eGFR values. At 18 months, hemoglobin, serum ferritin and TSAT values increased significantly from baseline in the FCM group, compared with the ferrous sulfate group. ESAs dose and rate of infusion decreased only in the FCM group. At 18 months, the treatment costs, analysed per week, was higher in the ferrous sulfate group, compared with the FCM group, and this was mostly due to a reduction in ESAs prescription in the FCM group. Routine intravenous FCM treatment in an outpatient clinic of NDD-CKD patients results in better correction of iron-deficiency anemia when compared to ferrous sulfate. In addition to this, treating NDD-CKD patients with FCM leads to a significant reduction of the treatment costs by reducing ESAs use.

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Safety and Efficacy of High Dose Intravenous Ferric Carboxymaltose vs. Standard Medical Care in the Treatment of Iron Deficiency Anemia

The American Journal of Gastroenterology ◽

10.14309/00000434-201110002-01091 ◽

2011 ◽

Vol 106 ◽

pp. S406-S407

Author(s):

Charles Barish ◽

David Bregman ◽

Angelia Butcher ◽

Todd Koch ◽

David Morris

Keyword(s):

Iron Deficiency ◽

Medical Care ◽

Iron Deficiency Anemia ◽

Deficiency Anemia ◽

Ferric Carboxymaltose ◽

High Dose ◽

Safety And Efficacy ◽

Standard Medical Care

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Comparative Review of the Safety and Efficacy of Ferric Carboxymaltose Versus Standard Medical Care for the Treatment of Iron Deficiency Anemia in Bariatric and Gastric Surgery Patients

Obesity Surgery ◽

10.1007/s11695-013-0939-6 ◽

2013 ◽

Vol 23 (9) ◽

pp. 1413-1420 ◽

Cited By ~ 18

Author(s):

Margaret Malone ◽

Charles Barish ◽

Andy He ◽

David Bregman

Keyword(s):

Iron Deficiency ◽

Medical Care ◽

Iron Deficiency Anemia ◽

Gastric Surgery ◽

Deficiency Anemia ◽

Ferric Carboxymaltose ◽

Safety And Efficacy ◽

Standard Medical Care ◽

Comparative Review

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Ferric Citrate Dosing in Iron Deficiency Anemia in Nondialysis-Dependent Chronic Kidney Disease

American Journal of Nephrology ◽

10.1159/000516012 ◽

2021 ◽

pp. 1-10

Author(s):

Pablo E. Pergola ◽

Diogo Belo ◽

Paul Crawford ◽

Moustafa Moustafa ◽

Wenli Luo ◽

...

Keyword(s):

Chronic Kidney Disease ◽

Kidney Disease ◽

Iron Deficiency ◽

Iron Deficiency Anemia ◽

Ferric Citrate ◽

Deficiency Anemia ◽

Open Label ◽

Starting Dose ◽

Dosing Regimens

Introduction: Ferric citrate (FC) is indicated as an oral iron replacement for iron deficiency anemia in adult patients with chronic kidney disease (CKD) not on dialysis. The recommended starting dose is one 1-g tablet three times daily (TID). This study investigated long-term efficacy and safety of different FC dosing regimens for treating anemia in nondialysis-dependent CKD (NDD-CKD). Methods: In this phase 4, randomized, open-label, multicenter study, patients with anemia with NDD-CKD (estimated glomerular filtration rate, ≥20 mL/min and <60 mL/min) were randomized 1:1 to one FC tablet (1-g equivalent to 210 mg ferric iron) TID (3 g/day) or 2 tablets twice daily (BID; 4 g/day). At week 12, dosage was increased to 2 tablets TID (6 g/day) or 3 tablets BID (6 g/day) in patients whose hemoglobin (Hb) levels increased <0.5 g/dL or were <10 g/dL. Primary endpoint was mean change in Hb from baseline to week 24. Results: Of 484 patients screened, 206 were randomized and 205 received FC. Mean (standard deviation) changes from baseline in Hb at week 24 were 0.77 (0.84) g/dL with FC TID 3 g/day and 0.70 (0.98) g/dL with FC BID 4 g/day. Discussion/Conclusions: FC administered BID and TID for 48 weeks was safe and effective for treating anemia in this population, supporting potentially increased dosing flexibility.

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Role of Serum Transferrin Receptor in Diagnosing and Differentiating Iron Deficiency Anemia from Anemia of Chronic Disease in Patients with Chronic Kidney Disease

BIRDEM Medical Journal ◽

10.3329/birdem.v7i2.32451 ◽

2017 ◽

Vol 7 (2) ◽

pp. 132-137

Author(s):

Abdul Latif ◽

Muhammad Rafiqul Alam ◽

Asia Khanam ◽

Farhana Hoque ◽

Muhammad Abdur Rahim ◽

...

Keyword(s):

Chronic Kidney Disease ◽

Chronic Disease ◽

Kidney Disease ◽

Iron Deficiency ◽

Iron Deficiency Anemia ◽

Transferrin Receptor ◽

Deficiency Anemia ◽

Control Group ◽

Anemia Of Chronic Disease ◽

Female Ratio

Background: Anemia is common in patients with chronic kidney disease (CKD) and this is generally anemia of chronic disease, but iron deficiency anemia (IDA) is also common. Soluble transferrin receptor (sTfR) is a useful marker for IDA. Present study was undertaken to assess the utility of sTfR as a marker of IDA in selected group of Bangladeshi patients with CKD.Methods: This cross-sectional study was conducted in the Department of Nephrology, BSMMU, Dhaka, Bangladesh from January 2013 to December 2014. Patients with anemia admitted in nephrology department whether on hemodialysis or not and medicine department of BSMMU were taken for study. The study population was further divided into two groups; Group A, patients who are having IDA and Group B, patients with ACD and a control group was also selected. Data were collected by face to face interview and laboratory investigations with a self-administered questionnaire.Results: The mean age of the patients in two study groups were 38.40±13.23 and 34.85±10.52 years respectively and male-female ratio were 0.5:1 and 1:0.5. Mean sTfR level was higher (4.81± 1.64 ?g/ml) in patients with IDA than (2.89±1.40 ?g/ml) in patients with ACD (p <0.0001). In our study mean ferritin level was 599.59± 449.15?g/L in ACD patients whereas 101.23±119.42 in IDA patients (p<0.0001). Total iron binding capacity (TIBC) was more in ACD patients with sTfRe3?g/ml as compared to ACD patients with sTfR<3?g/ml. Transferrin saturation (TSAT) level was significantly decreased in ACD patients with sTfR ?3?g/ml as compared to ACD patients with sTfR<3?g/ml.Conclusion: sTfR has a comparable ability to S. ferritin in diagnosing IDA and ACD. However, sTfR and serum ferritin alone cannot definitely exclude co-existing iron deficiency in ACD. As sTfR is not affected by infection and/or inflammation, thus providing a non-invasive alternative to bone marrow study.Birdem Med J 2017; 7(2): 132-137

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