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Preliminary experience on the use of sucrosomial iron in hemodialysis: focus on safety, hemoglobin maintenance and oxidative stress

  • Nephrology - Original Paper
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Abstract

Purpose

Iron is usually administered in hemodialysis patients by parenteral route, as oral absorption is poor due to high hepcidin levels. However, administrations of intravenous iron and iron overload are associated with high oxidative stress and systemic inflammation that can affect patient survival. With this study, we evaluated an alternative type of oral iron for the treatment of anemia in hemodialysis patients. The formulation consists in ferric pyrophosphate covered by phospholipids plus sucrose ester of fatty acid matrix, named sucrosomial iron, whose absorption is not influenced by hepcidin.

Methods

Twenty-four (24) patients undergoing chronic hemodialysis switched iron supplementation from intravenous (ferric gluconate 62.5 mg weekly) to oral (sucrosomial iron, 90 mg weekly in 3 administrations of 30 mg) route for 3 months. Classical anemia, iron metabolism, inflammation and nutritional biomarkers were monitored, as well as biomarkers of oxidative stress, such as protein-bound di-tyrosines, protein carbonylation, advanced oxidation protein products and protein thiols.

Results

Over the 3 months, hemoglobin values remained stable, as the values of hematocrit and mean corpuscular volume. In parallel, other anemia parameters dropped, including ferritin, transferrin saturation and serum iron. On the other side, nutritional biomarkers, such as total proteins and transferrin, increased significantly during the time frame. We also observed a significant decrease in white blood cells as well as a non-significant reduction in C-reactive protein and some oxidative stress biomarkers, such as protein carbonyls and di-tyrosines.

Conclusion

Our study demonstrates that a therapy with sucrosomial iron in hemodialysis patients is safe and can maintain stable hemoglobin levels in a three-month period with a possible beneficial effect on oxidative stress parameters. However, the reduction of ferritin and transferrin saturation suggests that a weekly dosage of 90 mg is not sufficient in hemodialysis patients in the long time to maintain hemoglobin.

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Data availability

Data are available under reasonable circumstances by direct contact with the corresponding author.

Code availability

Not applicable.

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Funding

This research has been partially funded by Pharmanutra SpA (Pisa, Tuscany, Italy).

Author information

Authors and Affiliations

  1. Nephrology and Dialysis Unit, Humanitas Clinical and Research Center, Manzoni 56, 20089, Rozzano, Milan, Italy

    Francesco Reggiani, Silvia Finazzi, Claudio Angelini & David Cucchiari

  2. Department of Biosciences, Università Degli Studi Di Milano, Milan, Italy

    Graziano Colombo, Emanuela Astori, Lucia Landoni, Aldo Milzani & Isabella Dalle-Donne

  3. Renal Transplant Unit, Hospital Clínic, Barcelona, Spain

    David Cucchiari

Authors
  1. Francesco Reggiani
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  2. Graziano Colombo
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  3. Emanuela Astori
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  4. Lucia Landoni
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  5. Silvia Finazzi
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  6. Aldo Milzani
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  7. Claudio Angelini
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  8. Isabella Dalle-Donne
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  9. David Cucchiari
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Contributions

FR was involved in data collection and analysis and writing of the manuscript, GC, EA, LL, AM and IDD were involved in the research protocol, analysis of oxidative stress biomarkers and writing of the manuscript, SF and CA were involved in the research protocol and patients recruitment, DC conceived the study and was involved in the research protocol, data analysis and writing of the manuscript.

Corresponding author

Correspondence to David Cucchiari.

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Conflicts of interest

DC has received speaker fees from Pharmanutra. All the other Authors reported no conflict of interest.

Ethical approval

The study was approved by Humanitas Clinical and Research Center review board before initiation and carried out according to the Code of Ethics of the World Medical Association (Declaration of Helsinki).

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A signed informed consent has been obtained for each participant.

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Reggiani, F., Colombo, G., Astori, E. et al. Preliminary experience on the use of sucrosomial iron in hemodialysis: focus on safety, hemoglobin maintenance and oxidative stress. Int Urol Nephrol 54, 1145–1153 (2022). https://doi.org/10.1007/s11255-021-02983-8

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  • DOI: https://doi.org/10.1007/s11255-021-02983-8

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