Kidney Week

Abstract: FR-PO0139

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

Session Information

• AKI: Epidemiology and Clinical Trials
  November 07, 2025 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Acute Kidney Injury

• 102 AKI: Clinical, Outcomes, and Trials

Authors

• Chavez, Jonathan, Universidad de Guadalajara, Guadalajara, Jal., Mexico

Jonathan Chavez, PhD

• Garcia-Garcia, Guillermo, Universidad de Guadalajara, Guadalajara, Jal., Mexico

Guillermo Garcia-Garcia, MD, FASN

• Navarro Blackaller, Guillermo, Universidad de Guadalajara, Guadalajara, Jal., Mexico

Guillermo Navarro Blackaller, MD

• Medina, Ramon, Universidad de Guadalajara, Guadalajara, Jal., Mexico

Ramon Medina, MD

• Alcantar Vallin, Maria de la Luz, Universidad de Guadalajara, Guadalajara, Jal., Mexico

Maria de la Luz Alcantar Vallin, MD

• Martínez Gallardo González, Alejandro, Hospital Civil de Guadalajara, Guadalajara, Jal., Mexico

Alejandro Martínez Gallardo González

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.

Digital Object Identifier (DOI)

• doi: 10.1681/ASN.2025ynxpqmjc