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A randomized, controlled, open label non-inferiority trial of intravenous ferric carboxymaltose versus iron sucrose in patients with iron deficiency anemia in China

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Abstract

Iron deficiency (ID) and ID anemia (IDA) pose significant public health concerns in China. Although iron sucrose (IS) treatment is well-established in the country, ferric carboxymaltose (FCM) offers the advantage of higher doses and fewer infusions. This open label, randomized, controlled, non-inferiority trial was conducted at multiple sites in China to compare the outcomes of FCM (maximum of 2 doses, 500 or 1000 mg iron) and IS (up to 11 infusions, 200 mg iron) treatments in subjects with IDA. The primary endpoint was the achievement of hemoglobin (Hb) response (an increase of ⩾2 g/dL from baseline) within 8 weeks, whereas secondary endpoints included changes in Hb, transferrin saturation, and serum ferritin levels. Among the 371 randomized subjects, a similar percentage of subjects treated with FCM and IS achieved Hb-response (FCM 99.4%, IS 98.3%), thereby confirming the non-inferiority of FCM compared with IS (difference 1.12 (−2.15, 4.71; 95% confidence interval (CI))). Furthermore, a significantly higher proportion of FCM-treated subjects achieved early Hb-response at Week 2 (FCM 85.2%, IS 73.2%; difference 12.1 (3.31, 20.65; 95% CI)). Additionally, the increase in TSAT and serum ferritin levels from baseline was significantly greater at all time points for FCM-treated subjects. The safety profiles of FCM and IS were comparable, with the exception of transient hypophosphatemia and pyrexia, which are consistent with FCM’s known safety profile. In conclusion, FCM proves to be an efficacious treatment for IDA, providing faster Hb-response and correction of ID with fewer administrations than IS.

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Acknowledgements

We express our gratitude to all principal investigators at the participating sites (Table S2) and acknowledge the contributions of the entire study staff. The funding for medical writing support was provided by Vifor Pharma, Glattbrugg, Switzerland.

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Authors and Affiliations

  1. The First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, 310058, China

    Jie Jin

  2. Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China

    Zhihua Ran

  3. Vifor Pharma, Glattbrugg, 8152, Switzerland

    Emanuele Noseda, Bernard Roubert, Matthieu Marty, Anna Mezzacasa & Udo Michael Göring

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  1. Jie Jin
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Correspondence to Anna Mezzacasa.

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Conflicts of interest Emanuele Noseda, Bernard Roubert, Matthieu Marty, Anna Mezzacasa, and Udo Michael Göring are employees of Vifor Pharma, Glattbrugg, Switzerland. Jie Jin and Zhihua Ran declare no conflicts of interest.

The study was approved by the appropriate institutional and/or national research ethics committee (see Table S1 for names of the ethics committees) and the study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. Informed consent was obtained from all patients for their inclusion in the study.

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Jin, J., Ran, Z., Noseda, E. et al. A randomized, controlled, open label non-inferiority trial of intravenous ferric carboxymaltose versus iron sucrose in patients with iron deficiency anemia in China. Front. Med. 18, 98–108 (2024). https://doi.org/10.1007/s11684-023-1001-2

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  • DOI: https://doi.org/10.1007/s11684-023-1001-2

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