Clinical Trial

Labile Iron Removal by Adding the Iron Chelator MEX-CD1 to Dialysate in Sepsis-Associated Acute Kidney Injury

Study acronym: IRON-IC
Recruiting Phase 1/2
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Summary
The goal of this clinical trial is to learn if adding the iron-binding drug MEX-CD1 to dialysis fluid can help remove excess iron in adults with sepsis-associated acute kidney injury (AKI) requiring dialysis who are in the intensive care unit (ICU). The main questions it aims to answer are: Does adding MEX-CD1 to the dialysis fluid increase the amount of iron removed during dialysis? Is using MEX-CD1 in dialysis fluid safe for patients? Participants will: Be adults in the ICU with sepsis-associated AKI who need continuous dialysis (renal replacement therapy) Receive two 24-hour dialysis sessions: one with standard dialysis fluid and one with dialysis fluid containing MEX-CD1 Serve as their own control, meaning they will receive both treatments Researchers will measure: The amount of iron removed in the dialysis waste fluid (primary outcome) Blood levels of iron Changes in other trace elements Markers of inflammation and oxidative stress Safety outcomes up to 28 days after treatment This is a pilot study being done at a single hospital in France.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-06-06
notable Primary completion pushed: 2027-02-01 -> 2027-06-01 2026-06-06
minor Completion pushed: 2028-05 -> 2028-06 2026-06-06
Trial Details
NCT Number NCT07236463
Lead Sponsor Centre Hospitalier Universitaire de Nīmes
Conditions Acute Kidney Injury, Sepsis
Enrollment 14 participants
Start Date 2026-06-04
Primary Completion 2027-06-01 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-05