Effect of Intravenous Iron on MAKE in Patients with AKI Ferropenia: A Phase 2, Randomized, Double-Blind, Controlled Trial

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Background: During AKI, ferropenia may contribute to worse clinical outcome by interfering cellular repair. Correcting ferropenia with intravenous (IV) dextran iron may reduce the risk of major adverse kidney events (MAKE). We aimed to assess if IV iron was more efficacious than conventional management for reducing MAKE in AKI-ferropenic patients. Methods: In a phase 2 randomized controlled trial, from July 2022 to September 2024, patients with AKI and ferropenia (iron levels <13 μmol/L or a transferrin saturation <20%) were eligible. We randomly assigned 120 patients to the control (N=62) and intervention groups (single 1,200 mg IV dextran iron infusion; N=58). Primary outcome was the risk of MAKE at 90 days (MAKE90). MAKE were defined as death, kidney replacement therapy (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. Conclusion: In patients with AKI and ferropenia, a single dose of IV iron, compared to usual care, did not improve clinical outcomes evaluated by MAKE90, the hemoglobin value, but was safe. Trial registration: ClinicalTrials.gov, ID: NCT05960227 registered 09/19/2022, IRB approval 159/22.

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