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

NCT07236463 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-01-22

No results posted yet for this study

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.

Conditions

Interventions

COMBINATION_PRODUCT

Continuous veino-veinous dialysis with iron-chelator 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 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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Saber D BARBAR, MD, PhD · Centre Hospitalier Universitaire de Nīmes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-02-01
Completion
2028-05-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07236463 on ClinicalTrials.gov