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

Sponsor
Centre Hospitalier Universitaire de Nīmes
Study ID
NCT07236463
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Acute Kidney Injury
  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Continuous veino-veinous dialysis with iron-chelator supplemented dialysate — COMBINATION_PRODUCT
    Participants will receive two consecutive 24-hour CVVHD sessions using: * Standard Dialysate: Commercially available CiCa™ dialysate (Fresenius Medical Care, Germany) * MEX-CD1 Dialysate: CiCa™ dialysate supplemented with MEX-CD1 at 50 mg/L (28). MEX-CD1 remains confined to the dialysate, separated from the patient's circulation by the dialysis membrane because of its molecular weight Both sessions will use identical RRT parameters, no dose escalation is planned: * Continuous veno-venous hemodialysis (CVVHD) modality * Multifiltrate™ dialyzer (Fresenius Medical Care, Germany) with regional citrate anticoagulation * Dialysis dose of 20-25 mL/kg/h (approx. 1600 mL/h dialysate flow) * Blood flow 80 mL/min * Ultrasound-guided placement of a 15 cm 16 F double-lumen catheter in the right internal jugular vein * The circuit and the dialysis filter will be changed after each 24 hours CVVHD session

Study Details

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.

Key Dates

First listed
Nov 19, 2025
Start date
Jun 4, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
14 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Other: Sequence A: MEX-CD1-supplemented dialysate first, then standard dialysate
    Participants will receive two consecutive 24-hour CVVHD sessions using: * Standard Dialysate: Commercially available CiCa™ dialysate (Fresenius Medical Care, Germany) * MEX-CD1 Dialysate: CiCa™ dialysate supplemented with MEX-CD1 at 50 mg/L (28). MEX-CD1 remains confined to the dialysate, separated from the patient's circulation by the dialysis membrane because of its molecular weight
  • Other: Sequence B: Standard dialysate first, then MEX-CD1-supplemented dialysate
    Participants will receive two consecutive 24-hour CVVHD sessions using: * Standard Dialysate: Commercially available CiCa™ dialysate (Fresenius Medical Care, Germany) * MEX-CD1 Dialysate: CiCa™ dialysate supplemented with MEX-CD1 at 50 mg/L (28). MEX-CD1 remains confined to the dialysate, separated from the patient's circulation by the dialysis membrane because of its molecular weight

Primary Outcome Measure

Free iron concentrations in the dialysis effluent [ Time Frame: 48 hours (2 consecutive sessions of 24 hours CVVHD) ]

Central Contacts

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