Acute Kidney InjuryPhase 1/2IRON-ICNCT07236463
Labile Iron Removal by Adding the Iron Chelator MEX-CD1 to Dialysate in Sepsis-Associated Acute Kidney Injury
A Phase 1/2 study testing Continuous veino-veinous dialysis with iron-chelator supplemented dialysate in people with Acute Kidney Injury and Sepsis, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Sepsis
- What is being tested?
- Continuous veino-veinous dialysis with iron-chelator supplemented dialysate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Jun 2026to Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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
Who cannot join
- Known shellfish allergy
- Moribund status with life expectancy too low to benefit
- Concurrent participation in another interventional study
- Under legal protection (guardianship or curatorship)
- Inability to obtain informed consent from patient or representative
- Pregnant, parturient, or breastfeeding women
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Nimes University Hospital
Nîmes, Gard, 30000
- Recruiting
CHU de Nîmes
Nîmes, 30029
Saber BARBAR, PH, + 33 4.66.68.33.20, saber.barbar@chu-nimes.fr
About this study
Official title: Performance and Safety of Labile Iron Removal by Adding the Iron Chelator MEX-CD1 to Dialysate During Continuous Veno-venous Hemodialysis for Sepsis-associated AKI: Protocol for a Phase I-II Randomized Crossover Pilot Study.
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?
Read more
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.
Read the detailed description
Sepsis-associated acute kidney injury (AKI) is a common and serious complication in critically ill patients admitted to intensive care units (ICUs). It is associated with high rates of death and long-term health problems. Currently, there is no specific treatment to address the underlying causes of this condition beyond supportive measures such as dialysis to replace kidney function.
A growing body of research suggests that excess circulating labile (easily reactive) iron plays an important role in the development of organ injury during sepsis. Labile iron can promote oxidative stress, mitochondrial damage, and cell death through a process called ferroptosis. Reducing the amount of labile iron in the bloodstream may help limit these harmful effects.
This study is designed to evaluate a new approach to lowering labile iron levels during continuous renal replacement therapy (CRRT) in patients with sepsis-associated AKI. The investigational strategy uses an iron-binding compound (iron chelator) called MEX-CD1 added to the dialysis fluid (dialysate) during continuous veno-venous hemodialysis (CVVHD). By binding iron in the dialysis circuit, the chelator aims to enhance the removal of labile iron from the patient's blood without requiring systemic administration of the chelating agent.
This is a single-centre, randomised, open-label, two-period crossover phase I-II pilot study conducted in the ICU of Nîmes University Hospital in France. Each participant will undergo two consecutive 24-hour sessions of CVVHD, one using standard dialysate and one using dialysate supplemented with MEX-CD1 at a concentration of 50 mg/L. The order of the sessions will be randomised so that each participant serves as their own control, helping to reduce variability due to individual differences in illness severity or metabolism.
The primary objective of the study is to assess the performance of iron removal by measuring the concentration of iron in the dialysis effluent. Secondary objectives include evaluating plasma iron clearance, monitoring for loss of other trace elements, and assessing biomarkers related to oxidative stress and inflammation. Safety outcomes will also be closely monitored during the dialysis sessions and for 28 days afterward, including any adverse events related to the use of MEX-CD1 in the dialysate.
This pilot study will generate preliminary data on the feasibility, safety, and potential effectiveness of this novel dialysis-based iron removal strategy. If successful, it may support the development of larger trials aimed at improving outcomes for critically ill patients with sepsis-associated AKI.
- Conditions
- Acute Kidney Injury, Sepsis
- Being tested
- Continuous veino-veinous dialysis with iron-chelator supplemented dialysate
- Keywords
- Acute Kidney Injury, Sepsis, Continuous Renal Replacement Therapy, Iron Chelating Agents, Intensive Care Unit
- Medical subject headings
- Acute Kidney Injury, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous veino-veinous dialysis with iron-chelator supplemented dialysateCombination 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 group | Role | What they receive |
|---|---|---|
| Sequence A: MEX-CD1-supplemented dialysate first, then standard dialysate | Other | 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 Receives: Combination Product: Continuous veino-veinous dialysis with iron-chelator supplemented dialysate |
| Sequence B: Standard dialysate first, then MEX-CD1-supplemented dialysate | Other | 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 Receives: Combination Product: Continuous veino-veinous dialysis with iron-chelator supplemented dialysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free iron concentrations in the dialysis effluent
The primary outcome is defined as the comparison of free iron concentrations in the effluent collected during 24-hour dialysis sessions performed under two conditions: using standard dialysate and using dialysate supplemented with the iron chelator MEX-CD1.
Measured: 48 hours (2 consecutive sessions of 24 hours CVVHD)
Secondary outcomes (8)
24-hour serum iron clearance
24-hour serum iron clearance with iron chelation by addition of MEX-CD1 to the dialysate.
Measured: 48 hours
ratio iron clearance/creatinine clearance
Compare the ratio of 24-hour plasma iron clearance to creatinine clearance between standard dialysate and MEX-CD1-supplemented dialysate.
Measured: 48 hours
Plasma malondialdehyde concentration
The impact of iron chelation, achieved by adding MEX-CD1 to the dialysate, will be assessed on oxidative stress biomarkers by measuring plasma malondialdehyde concentrations every 8 hours for 48 hours.
Measured: From enrollment until the end of the intervention at 48 hours.
Plasma Thiobarbituric Acid Reactive Substances (TBARS)
The impact of iron chelation, achieved by adding MEX-CD1 to the dialysate, will be assessed on oxidative stress biomarkers by measuring Plasma Thiobarbituric Acid Reactive Substances (TBARS) concentrations every 8 hours for 48 hours.
Measured: From enrollment until the end of the intervention at 48 hours.
Plasma protein thiols
The impact of iron chelation, achieved by adding MEX-CD1 to the dialysate, will be assessed on oxidative stress biomarkers by measuring plasma protein thiol concentrations every 8 hours for 48 hours.
Measured: From enrollment until the end of the intervention at 48 hours.
Plasma Glutathione Peroxidase (GPx) concentration
The impact of iron chelation, achieved by adding MEX-CD1 to the dialysate, will be assessed on oxidative stress biomarkers by measuring plasma Glutathione Peroxidase (GPx) concentrations every 8 hours for 48 hours.
Measured: From enrollment until the end of the intervention at 48 hours.
Plasma C-reactive protein levels
The impact of iron chelation, achieved by adding MEX-CD1 to the dialysate, will be assessed on inflammatory biomarkers by measuring plasma C-reactive protein levels every 8 hours for 48 hours.
Measured: From enrollment until the end of the intervention at 48 hours.
Plasma procalcitonin levels
The impact of iron chelation, achieved by adding MEX-CD1 to the dialysate, will be assessed on inflammatory biomarkers by measuring plasma procalcitonin levels every 8 hours for 48 hours.
Measured: From enrollment until the end of the intervention at 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start4 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized in a 1:1 ratio to one of two treatment sequences using a computer-generated, block-randomized list prepared by an independent statistician. * Sequence A: MEX-CD1-supplemented dialysate first, then standard dialysate * Sequence B: Standard dialysate first, then MEX-CD1-supplemented dialysate
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saber D BARBAR, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236463
- Sponsor's protocol ID
- NIMAO/2023-1/SB-01
- Acronym
- IRON-IC
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grange C, Lux F, Brichart T, David L, Couturier A, Leaf DE, Allaouchiche B, Tillement O. Iron as an emerging therapeutic target in critically ill patients. Crit Care. 2023 Dec 4;27(1):475. doi: 10.1186/s13054-023-04759-1.
PubMed 38049866Natuzzi M, Grange C, Grea T, Brichart T, Aigle A, Bechet D, Hautefeuille B, Thomas E, Ayoub JY, Bonnet JM, Louzier V, Allaouchiche B, Couturier A, Montembault A, de Oliveira PN, David L, Lux F, Tillement O. Feasibility study and direct extraction of endogenous free metallic cations combining hemodialysis and chelating polymer. Sci Rep. 2021 Oct 7;11(1):19948. doi: 10.1038/s41598-021-99462-y.
PubMed 34620952Couturier A, Serrand C, Masseguin C, Allaouchiche B, Tillement O, Lefrant JY, Barbar SD. Evaluation of the performance and safety of adding the iron chelator MEX-CD1 to dialysate during continuous veno-venous haemodialysis for removing excess labile iron in intensive care patients with sepsis-associated acute kidney injury - the Iron in Intensive Care trial (IRON-I.C.): protocol for a phase I-II randomised crossover pilot study. BMJ Open. 2025 Dec 23;15(12):e109783. doi: 10.1136/bmjopen-2025-109783.
PubMed 41436269
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety of Labile Iron Removal by Adding the Iron Chelator MEX-CD1 to Dialysate During Continuous Veno-venous Hemodialysis for Sepsis-associated AKI: Protocol for a Phase I-II Randomized Crossover Pilot Study.
- ClinicalTrials.gov ID
- NCT07236463
- Acronym / sponsor ID
- IRON-IC / NIMAO/2023-1/SB-01
- Conditions
- Acute Kidney Injury, Sepsis
- Keywords
- Acute Kidney Injury, Sepsis, Continuous Renal Replacement Therapy, Iron Chelating Agents, Intensive Care Unit
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sepsis-associated acute kidney injury (AKI) is a common and serious complication in critically ill patients admitted to intensive care units (ICUs). It is associated with high rates of death and long-term health problems. Currently, there is no specific treatment to address the underlying causes of this condition beyond supportive measures such as dialysis to replace kidney function.
A growing body of research suggests that excess circulating labile (easily reactive) iron plays an important role in the development of organ injury during sepsis. Labile iron can promote oxidative stress, mitochondrial damage, and cell death through a process called ferroptosis. Reducing the amount of labile iron in the bloodstream may help limit these harmful effects.
This study is designed to evaluate a new approach to lowering labile iron levels during continuous renal replacement therapy (CRRT) in patients with sepsis-associated AKI. The investigational strategy uses an iron-binding compound (iron chelator) called MEX-CD1 added to the dialysis fluid (dialysate) during continuous veno-venous hemodialysis (CVVHD). By binding iron in the dialysis circuit, the chelator aims to enhance the removal of labile iron from the patient's blood without requiring systemic administration of the chelating agent.
This is a single-centre, randomised, open-label, two-period crossover phase I-II pilot study conducted in the ICU of Nîmes University Hospital in France. Each participant will undergo two consecutive 24-hour sessions of CVVHD, one using standard dialysate and one using dialysate supplemented with MEX-CD1 at a concentration of 50 mg/L. The order of the sessions will be randomised so that each participant serves as their own control, helping to reduce variability due to individual differences in illness severity or metabolism.
The primary objective of the study is to assess the performance of iron removal by measuring the concentration of iron in the dialysis effluent. Secondary objectives include evaluating plasma iron clearance, monitoring for loss of other trace elements, and assessing biomarkers related to oxidative stress and inflammation. Safety outcomes will also be closely monitored during the dialysis sessions and for 28 days afterward, including any adverse events related to the use of MEX-CD1 in the dialysate.
This pilot study will generate preliminary data on the feasibility, safety, and potential effectiveness of this novel dialysis-based iron removal strategy. If successful, it may support the development of larger trials aimed at improving outcomes for critically ill patients with sepsis-associated AKI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to one of two treatment sequences using a computer-generated, block-randomized list prepared by an independent statistician. * Sequence A: MEX-CD1-supplemented dialysate first, then standard dialysate * Sequence B: Standard dialysate first, then MEX-CD1-supplemented dialysate
| Arm | Type | Receives |
|---|---|---|
| Sequence A: MEX-CD1-supplemented dialysate first, then standard dialysate | Other | Combination Product: Continuous veino-veinous dialysis with iron-chelator supplemented dialysateParticipants 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 |
| Sequence B: Standard dialysate first, then MEX-CD1-supplemented dialysate | Other | Combination Product: Continuous veino-veinous dialysis with iron-chelator supplemented dialysateParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Known shellfish allergy
- Moribund status with life expectancy too low to benefit
- Concurrent participation in another interventional study
- Under legal protection (guardianship or curatorship)
- Inability to obtain informed consent from patient or representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous veino-veinous dialysis with iron-chelator supplemented dialysateParticipants 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 | Combination product | Sequence A: MEX-CD1-supplemented dialysate first, then standard dialysate, Sequence B: Standard dialysate first, then MEX-CD1-supplemented dialysate |
Primary outcome
Free iron concentrations in the dialysis effluent
Time frame: 48 hours (2 consecutive sessions of 24 hours CVVHD)
The primary outcome is defined as the comparison of free iron concentrations in the effluent collected during 24-hour dialysis sessions performed under two conditions: using standard dialysate and using dialysate supplemented with the iron chelator MEX-CD1.
8 secondary outcomes
24-hour serum iron clearance
Time frame: 48 hours
ratio iron clearance/creatinine clearance
Time frame: 48 hours
Plasma malondialdehyde concentration
Time frame: From enrollment until the end of the intervention at 48 hours.
Plasma Thiobarbituric Acid Reactive Substances (TBARS)
Time frame: From enrollment until the end of the intervention at 48 hours.
Plasma protein thiols
Time frame: From enrollment until the end of the intervention at 48 hours.
Plasma Glutathione Peroxidase (GPx) concentration
Time frame: From enrollment until the end of the intervention at 48 hours.
Plasma C-reactive protein levels
Time frame: From enrollment until the end of the intervention at 48 hours.
Plasma procalcitonin levels
Time frame: From enrollment until the end of the intervention at 48 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Background: PubMed 38049866Grange C, Lux F, Brichart T, David L, Couturier A, Leaf DE, Allaouchiche B, Tillement O. Iron as an emerging therapeutic target in critically ill patients. Crit Care. 2023 Dec 4;27(1):475. doi: 10.1186/s13054-023-04759-1.
- Background: PubMed 34620952Natuzzi M, Grange C, Grea T, Brichart T, Aigle A, Bechet D, Hautefeuille B, Thomas E, Ayoub JY, Bonnet JM, Louzier V, Allaouchiche B, Couturier A, Montembault A, de Oliveira PN, David L, Lux F, Tillement O. Feasibility study and direct extraction of endogenous free metallic cations combining hemodialysis and chelating polymer. Sci Rep. 2021 Oct 7;11(1):19948. doi: 10.1038/s41598-021-99462-y.
- Derived from this study: PubMed 41436269Couturier A, Serrand C, Masseguin C, Allaouchiche B, Tillement O, Lefrant JY, Barbar SD. Evaluation of the performance and safety of adding the iron chelator MEX-CD1 to dialysate during continuous veno-venous haemodialysis for removing excess labile iron in intensive care patients with sepsis-associated acute kidney injury - the Iron in Intensive Care trial (IRON-I.C.): protocol for a phase I-II randomised crossover pilot study. BMJ Open. 2025 Dec 23;15(12):e109783. doi: 10.1136/bmjopen-2025-109783.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saber D BARBAR, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Continuous veino-veinous dialysis with iron-chelator supplemented dialysate in people with Acute Kidney Injury and Sepsis, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saber D BARBAR, MD, PhD (0033466683320, saber.barbar@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free iron concentrations in the dialysis effluent (time frame: 48 hours (2 consecutive sessions of 24 hours CVVHD)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07236463, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.