{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T05:00:19Z","timestamp":1787029219343,"version":"build-2736575974"},"reference-count":21,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2024,4,24]],"date-time":"2024-04-24T00:00:00Z","timestamp":1713916800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Nutrients"],"abstract":"<jats:p>Introduction. Iron deficiency is common in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD). Oral iron supplementation is recommended in these patients, but it is associated with a higher incidence of gastrointestinal adverse reactions. Liposomal iron therapy has been proposed as a new iron formulation, improving iron bioavailability with less side effects; however, few data are available in patients with NDD-CKD. Methods. We designed a single-arm pilot study to evaluate the efficacy of liposomal iron administered for six months in correcting iron deficiency (defined as serum ferritin &lt; 100 ng\/mL and\/or transferrin saturation &lt; 20%) in patients with NDD-CKD stages 1\u20135. The primary endpoints were the achievement of serum ferritin \u2265 100 ng\/mL and transferrin saturation \u2265 20%. Secondary outcomes were hemoglobin (Hb) changes and the safety of liposomal iron. Results. The efficacy population included 34\/38 patients, who completed at least one visit after baseline. Liposomal iron increased the achievement of transferrin saturation targets from 11.8% at baseline to 50.0% at month 6 (p = 0.002), while no significant correction of serum ferritin (p = 0.214) and Hb was found (p = 0.465). When patients were stratified by anemia (Hb &lt; 12 g\/dL in women and Hb &lt; 13 g\/dL in men), a significant improvement of transferrin saturation was observed only in anemic patients (from 13.3 \u00b1 5.8% to 20.2 \u00b1 8.1%, p = 0.012). Hb values slightly increased at month 6 only in anemic patients (+0.60 g\/dL, 95%CI \u22120.27 to +1.48), but not in those without anemia (+0.08 g\/dL, 95%CI \u22120.73 to +0.88). In patients taking at least one dose of liposomal iron (safety population, n = 38), the study drug was discontinued in eight patients due to death (n = 2), a switch to intravenous iron (n = 2), and the occurrence of side effects (n = 4). Conclusions. The use of liposomal iron in patients with NDD-CKD is associated with a partial correction of transferrin saturation, with no significant effect on iron storage and Hb levels.<\/jats:p>","DOI":"10.3390\/nu16091255","type":"journal-article","created":{"date-parts":[[2024,4,24]],"date-time":"2024-04-24T03:56:31Z","timestamp":1713930991000},"page":"1255","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Efficacy and Safety of Oral Supplementation with Liposomal Iron in Non-Dialysis Chronic Kidney Disease Patients with Iron Deficiency"],"prefix":"10.3390","volume":"16","author":[{"given":"Davide","family":"Cesarano","sequence":"first","affiliation":[{"name":"Unit of Nephrology, Department of Advanced Medical and Surgery Sciences of University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4414-4597","authenticated-orcid":false,"given":"Silvio","family":"Borrelli","sequence":"additional","affiliation":[{"name":"Unit of Nephrology, Department of Advanced Medical and Surgery Sciences of University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giorgia","family":"Campilongo","sequence":"additional","affiliation":[{"name":"Nephrology, Dialysis and Transplantation Unit, University of Bari \u201cAldo Moro\u201d, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annarita","family":"D\u2019Ambra","sequence":"additional","affiliation":[{"name":"Unit of Nephrology, Department of Advanced Medical and Surgery Sciences of University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"Papadia","sequence":"additional","affiliation":[{"name":"Nephrology, Dialysis and Transplantation Unit, University of Bari \u201cAldo Moro\u201d, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Garofalo","sequence":"additional","affiliation":[{"name":"Unit of Nephrology, Department of Advanced Medical and Surgery Sciences of University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonia","family":"De Marco","sequence":"additional","affiliation":[{"name":"Nephrology, Dialysis and Transplantation Unit, University of Bari \u201cAldo Moro\u201d, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"Marzano","sequence":"additional","affiliation":[{"name":"Unit of Nephrology, Department of Advanced Medical and Surgery Sciences of University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Ruotolo","sequence":"additional","affiliation":[{"name":"Unit of Nephrology, Department of Advanced Medical and Surgery Sciences of University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4861-0911","authenticated-orcid":false,"given":"Loreto","family":"Gesualdo","sequence":"additional","affiliation":[{"name":"Nephrology, Dialysis and Transplantation Unit, University of Bari \u201cAldo Moro\u201d, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4164-6978","authenticated-orcid":false,"given":"Pietro","family":"Cirillo","sequence":"additional","affiliation":[{"name":"Nephrology, Dialysis and Transplantation Unit, University of Bari \u201cAldo Moro\u201d, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5686-2089","authenticated-orcid":false,"given":"Roberto","family":"Minutolo","sequence":"additional","affiliation":[{"name":"Unit of Nephrology, Department of Advanced Medical and Surgery Sciences of University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,4,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"3035","DOI":"10.1093\/ndt\/gft338","article-title":"Anaemia management in non-dialysis chronic kidney disease (CKD) patients: A multicenter prospective study in renal clinics","volume":"28","author":"Minutolo","year":"2013","journal-title":"Nephrol. Dial. Transplant."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"868","DOI":"10.1053\/j.ajkd.2021.09.017","article-title":"Recent and Emerging Therapies for Iron Deficiency in Anemia of CKD: A Review","volume":"79","author":"Bazeley","year":"2022","journal-title":"Am. J. Kidney Dis."},{"key":"ref_3","doi-asserted-by":"crossref","unstructured":"Del Vecchio, L., and Minutolo, R. (2021). ESA, Iron Therapy and New Drugs: Are There New Perspectives in the Treatment of Anaemia?. J. Clin. Med., 10.","DOI":"10.3390\/jcm10040839"},{"key":"ref_4","unstructured":"Kidney Disease: Improving Global Outcomes (KDIGO) Anemia Work Group (2012). KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease. Kidney Int. Suppl., 2, 279\u2013335."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"1346","DOI":"10.1093\/ndt\/gft033","article-title":"Kidney Disease: Improving Global Outcomes guidelines on anaemia management in chronic kidney disease: A European Renal Best Practice position statement","volume":"28","author":"Locatelli","year":"2013","journal-title":"Nephrol. Dial. Transplant."},{"key":"ref_6","unstructured":"NICE Guideline (2024, March 30). Chronic Kidney Disease: Assessment and Management (NG203). Published: 25 August 2021. Available online: www.nice.org.uk\/guidance\/ng203."},{"key":"ref_7","first-page":"CD007857","article-title":"Parenteral versus oral iron therapy for adults and children with chronic kidney disease","volume":"2","author":"Hodson","year":"2019","journal-title":"Cochrane Database Syst. Rev."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"677","DOI":"10.1053\/j.ajkd.2016.04.018","article-title":"Intravenous versus oral iron supplementation for the treatment of anemia in CKD: An updated systematic review and meta-analysis","volume":"68","author":"Shepshelovich","year":"2016","journal-title":"Am. J. Kidney Dis."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"e02045","DOI":"10.1016\/j.heliyon.2019.e02045","article-title":"Risk of iron overload with chronic indiscriminate use of intravenous iron products in ESRD and IBD populations","volume":"5","author":"Rostoker","year":"2019","journal-title":"Heliyon"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"1118","DOI":"10.1681\/ASN.2019090972","article-title":"Intravenous Iron Dosing and Infection Risk in Patients on Hemodialysis: A Prespecified Secondary Analysis of the PIVOTAL Trial","volume":"31","author":"Macdougall","year":"2020","journal-title":"J. Am. Soc. Nephrol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"169","DOI":"10.1586\/17474086.2016.1124757","article-title":"Modulation of hepcidin to treat iron deregulation: Potential clinical applications","volume":"9","author":"Blanchette","year":"2016","journal-title":"Expert. Rev. Hematol."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"S61","DOI":"10.1046\/j.1523-1755.1999.055Suppl.69061.x","article-title":"Strategies for iron supplementation: Oral versus intravenous","volume":"69","author":"Macdougall","year":"1999","journal-title":"Kidney Int. Suppl."},{"key":"ref_13","doi-asserted-by":"crossref","unstructured":"G\u00f3mez-Ram\u00edrez, S., Brilli, E., Tarantino, G., Girelli, D., and Mu\u00f1oz, M. (2023). Sucrosomial\u00ae Iron: An Updated Review of Its Clinical Efficacy for the Treatment of Iron Deficiency. Pharmaceuticals, 16.","DOI":"10.3390\/ph16060847"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"604","DOI":"10.7326\/0003-4819-150-9-200905050-00006","article-title":"A new equation to estimate glomerular filtration rate. A new equation to estimate glomerular filtration rate","volume":"150","author":"Levey","year":"2009","journal-title":"Ann. Intern. Med."},{"key":"ref_15","unstructured":"World Health Organization (1968). Nutritional Anaemias: Report of a WHO Scientific Group."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"102","DOI":"10.1186\/1556-276X-8-102","article-title":"Liposome: Classification, preparation, and applications","volume":"8","author":"Akbarzadeh","year":"2013","journal-title":"Nanoscale Res. Lett."},{"key":"ref_17","doi-asserted-by":"crossref","unstructured":"Asperti, M., Gryzik, M., Brilli, E., Castagna, A., Corbella, M., Gottardo, R., Girelli, D., Tarantino, G., Arosio, P., and Poli, M. (2018). Sucrosomial\u00ae Iron Supplementation in Mice: Effects on Blood Parameters, Hepcidin, and Inflammation. Nutrients, 10.","DOI":"10.3390\/nu10101349"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"27","DOI":"10.1007\/s10534-021-00348-3","article-title":"Supplementation with Sucrosomial\u00ae iron leads to favourable changes in the intestinal microbiome when compared to ferrous sulfate in mice","volume":"35","author":"Zakrzewski","year":"2022","journal-title":"Biometals"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"446","DOI":"10.1016\/j.nefro.2019.10.006","article-title":"Liposomal iron in moderate chronic kidney disease. Hierro liposomal en la enfermedad renal cr\u00f3nica moderada","volume":"40","author":"Arrizabalaga","year":"2020","journal-title":"Nefrologia"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"645","DOI":"10.1093\/ndt\/gfu357","article-title":"Effect of oral liposomal iron versus intravenous iron for treatment of iron deficiency anaemia in CKD patients: A randomized trial","volume":"30","author":"Pisani","year":"2015","journal-title":"Nephrol. Dial. Transplant."},{"key":"ref_21","doi-asserted-by":"crossref","unstructured":"Giliberti, A., Curcio, A., Marchitto, N., Di Lullo, L., Paolozzi, F., Nano, F., Pironti, M., and Raimondi, G. (2022). Comparison of Ferric Sodium EDTA in combination with vitamin c, folic acid, copper gluconate, zinc gluconate, and selenomethionine as therapeutic option for chronic kidney disease patients with improvement in inflammatory status. 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