Recruiting PHASE1, PHASE2 Acute Kidney Injury

New treatment option for Acute Kidney Injury

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

ClinicalTrials.gov ID: NCT07236463

What this study is testing

What is Continuous veino-veinous dialysis with iron-chelator supplemented dialysate?

Continuous veino-veinous dialysis with iron-chelator supplemented dialysate is an investigational medicine, being studied as a potential treatment for acute kidney injury.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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?
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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...
  • AKI Stage 3 per KDIGO (Kidney Disease: Improving Global Outcomes) criteria: acute rise in serum creatinine ≥3 times baseline or serum creatinine ≥4...
  • Indications for CRRT: refractory hyperkalemia (\>6 mmol/L) or refractory metabolic acidosis (pH \< 7.20) or acute pulmonary edema unresponsive to...
  • Informed consent obtained from patient or legal representative

You likely can't join if

  • Known shellfish allergy
  • Moribund status with life expectancy too low to benefit
  • Concurrent participation in another treatment study
  • Exclusion period defined by another study
  • Under legal protection (guardianship or curatorship)
  • Inability to obtain informed consent from patient or representative
See the full eligibility criteria
Who can join
  • 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...
  • 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...
  • Informed consent obtained from patient or legal representative
  • Affiliated with or beneficiary of a health insurance plan
What rules you out
  • Known shellfish allergy
  • Moribund status with life expectancy too low to benefit
  • Concurrent participation in another treatment 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

The study team makes the final eligibility decision.

Where it's taking place

  • Nîmes, Gard, France
  • Nîmes, France

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Nîmes, Gard, France; Nîmes, France. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.