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

Study acronym: IRON-IC
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of Feb 1, 2026 to Jun 4, 2026 · Primary completion pushed from Feb 1, 2027 to Jun 1, 2027 · Completion pushed from May 2028 to Jun 2028 · 1 morev4 Show 4 more changesShow less
    • Start date changed from estimate of Feb 1, 2026 to Jun 4, 2026
    • Primary completion pushed from Feb 1, 2027 to Jun 1, 2027
    • Completion pushed from May 2028 to Jun 2028
    • Study sites: 1 to 2
  2. Start date: Dec 1, 2025 to Feb 1, 2026 Primary completion date: Dec 1, 2027 to Feb 1, 2027 · Completion date: Mar 2028 to May 2028v3 Show 2 more changesShow less
    • Primary completion date: Dec 1, 2027 to Feb 1, 2027
    • Completion date: Mar 2028 to May 2028
  3. Primary completion date: Nov 20, 2027 to Dec 1, 2027 Completion date: Jan 2028 to Mar 2028 · Start date: Nov 20, 2025 to Dec 1, 2025v2 Show 2 more changesShow less
    • Completion date: Jan 2028 to Mar 2028
    • Start date: Nov 20, 2025 to Dec 1, 2025
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07236463
Lead Sponsor Centre Hospitalier Universitaire de Nīmes
Conditions Acute Kidney Injury, Sepsis
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov