NCT07236463 Labile Iron Removal by Adding the Iron Chelator MEX-CD1 to Dialysate in Sepsis-Associated Acute Kidney Injury
| NCT ID | NCT07236463 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Condition | Acute Kidney Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2026-06-04 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 14 participants in total. It began in 2026-06-04 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Adult patients (≥18 years) admitted to ICU with sepsis-associated AKI requiring CRRT * Sepsis defined according to SEPSIS-3 criteria (suspected/documented infection with organ dysfunction indicated by ≥2-point increase in SOFA \[Sequential Organ Failure Assessment\] score) * AKI Stage 3 per KDIGO (Kidney Disease: Improving Global Outcomes) criteria: acute rise in serum creatinine ≥3 times baseline or serum creatinine ≥4 mg/dL or urine output \<0.3 mL/kg/h for ≥24 hours or anuria (urine output \<100ml) for ≥12 hours * Indications for CRRT: refractory hyperkalemia (\>6 mmol/L) or refractory metabolic acidosis (pH \< 7.20) or acute pulmonary edema unresponsive to medical management or urine output \<0.3 ml/kg/hour or anuria (urine output \<100ml) persistent for 48 hours and refractory to medical treatment * Informed consent obtained from patient or legal representative * Affiliated with or beneficiary of a health insurance plan Exclusion Criteria: * Known shellfish allergy * Moribund status with life expectancy too low to benefit * Concurrent participation in another interventional study * Exclusion period defined by another study * Under legal protection (guardianship or curatorship) * Inability to obtain informed consent from patient or representative * Pregnant, parturient, or breastfeeding women
Contact & Investigator
Saber D BARBAR, MD, PhD
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Nīmes
Frequently Asked Questions
Who can join the NCT07236463 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07236463 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07236463 currently recruiting?
Yes, NCT07236463 is actively recruiting participants. Contact the research team at saber.barbar@chu-nimes.fr for enrollment information.
Where is the NCT07236463 trial being conducted?
This trial is being conducted at Nîmes, France, Nîmes, France.
Who is sponsoring the NCT07236463 clinical trial?
NCT07236463 is sponsored by Centre Hospitalier Universitaire de Nīmes. The principal investigator is Saber D BARBAR, MD, PhD at Centre Hospitalier Universitaire de Nīmes. The trial plans to enroll 14 participants.
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