Kidney360 · 2026
Effect of Intravenous Iron Dextran on Kidney Outcomes in Acute Kidney Injury with Iron Deficiency: A Randomized Trial.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыНазвание и аннотация: Перевод пока не подготовлен
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Chávez-Iñiguez Jonathan S, Ibarra-Estrada Miguel, Carmona-Morales Edgar Joel, Ron-Magaña Ana, Claure-Del Granado Rolando, Velez Juan Carlos, Chávez-Alonso Gael, Orozco-Chan Carlos E, Villalvazo-Maciel Estefania, Anaya-Arce Tania M, Rodríguez-García Gonzálo, Navarro-Blackaller Guillermo, Medina-González Ramón, Gallardo-González Alejandro Martínez, Alcantar-Vallin Luz, Gómez-Fregoso Juan A, Abundis-Mora Gabriela J, García-García Guillermo
Аннотация
KEY POINTS: Iron deficiency is common in patients with AKI. It is unknown whether treating iron deficiency in AKI with intravenous iron reduces the risk of major adverse kidney events. In AKI and iron deficiency, intravenous iron did not reduce the risk of major adverse kidney events at 90 days.
BACKGROUND: During AKI, iron deficiency may contribute to worse clinical outcome by interfering cellular repair. Correcting iron deficiency with intravenous (IV) dextran iron may reduce the risk of major adverse kidney events (MAKEs). We aimed to assess whether IV iron was more efficacious than conventional management for reducing MAKE in patients with AKI-iron deficiency.
METHODS: In a phase 2 randomized controlled trial, from July 2022 to September 2024, patients with AKI and iron deficiency (iron levels <13 μ mol/L or a transferrin saturation <20%) were eligible. We randomly assigned 120 patients to the control ( N =62) and intervention groups (single 1200 mg IV dextran iron infusion; N =58). Primary outcome was the risk of MAKE at 90 days (MAKE90). MAKE were defined as death, KRT, or worsening kidney function. Each component of MAKE and hemoglobin were secondary outcomes.
RESULTS: The primary outcome MAKE90 occurred in 48 patients in the IV iron group and 47 in the control group (82% versus 75%; P = 0.37). Individual components of MAKE were similar in both groups, 36 (62.1%) versus 38 (61.3%) had worsened kidney function, 14 (24.1%) versus 13 (21%) initiated KRT, and mortality was 43.1% and 38.7% in the IV iron and control groups, respectively ( P ≥ 0.05 for all). Hemoglobin values and adverse events did not differ between groups during the study.
CONCLUSIONS: In patients with AKI and iron deficiency, a single dose of IV iron, compared with usual care, did not improve clinical outcomes evaluated by MAKE90, the hemoglobin value, but was safe.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: ClinicalTrials.gov, ID: NCT05960227 registered September 19, 2022, Institutional Review Board approval 159/22.
BACKGROUND: During AKI, iron deficiency may contribute to worse clinical outcome by interfering cellular repair. Correcting iron deficiency with intravenous (IV) dextran iron may reduce the risk of major adverse kidney events (MAKEs). We aimed to assess whether IV iron was more efficacious than conventional management for reducing MAKE in patients with AKI-iron deficiency.
METHODS: In a phase 2 randomized controlled trial, from July 2022 to September 2024, patients with AKI and iron deficiency (iron levels <13 μ mol/L or a transferrin saturation <20%) were eligible. We randomly assigned 120 patients to the control ( N =62) and intervention groups (single 1200 mg IV dextran iron infusion; N =58). Primary outcome was the risk of MAKE at 90 days (MAKE90). MAKE were defined as death, KRT, or worsening kidney function. Each component of MAKE and hemoglobin were secondary outcomes.
RESULTS: The primary outcome MAKE90 occurred in 48 patients in the IV iron group and 47 in the control group (82% versus 75%; P = 0.37). Individual components of MAKE were similar in both groups, 36 (62.1%) versus 38 (61.3%) had worsened kidney function, 14 (24.1%) versus 13 (21%) initiated KRT, and mortality was 43.1% and 38.7% in the IV iron and control groups, respectively ( P ≥ 0.05 for all). Hemoglobin values and adverse events did not differ between groups during the study.
CONCLUSIONS: In patients with AKI and iron deficiency, a single dose of IV iron, compared with usual care, did not improve clinical outcomes evaluated by MAKE90, the hemoglobin value, but was safe.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: ClinicalTrials.gov, ID: NCT05960227 registered September 19, 2022, Institutional Review Board approval 159/22.