Can a dialysis Add-On help sepsis patients by draining dangerous iron?
NCT ID NCT07236463
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether adding an iron-binding drug (MEX-CD1) to dialysis fluid can safely remove extra iron from the blood of adults in the ICU with sepsis and acute kidney injury. Each participant will receive two 24-hour dialysis sessions—one with standard fluid and one with the drug—to compare iron removal and safety. The goal is to see if this approach can reduce harmful iron levels that may worsen inflammation and organ damage.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 14 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de Nîmes
RECRUITINGNîmes, 30029, France
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Nimes University Hospital
NOT_YET_RECRUITINGNîmes, Gard, 30000, France
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