Myelodysplastic SyndromeMEXIRONNCT06781099
Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis
A study testing Low-volume continuous veno-venous haemodialysis with MEX-CD1 use in people with Myelodysplastic Syndrome and Myelofibrosis, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
In transfusion-dependent myelodysplastic syndromes patients, regular blood transfusions lead to iron overload, which can cause organ damage, hormonal imbalances, and increased infection risk, ultimately impacting patient survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome, Myelofibrosis
- What is being tested?
- Low-volume continuous veno-venous haemodialysis with MEX-CD1 use
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Jan 2026to 6 May 2027
- Phase
- Interventional
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
- Patient followed for myelodysplastic syndrome or myelofibrosis.
- Patient with platelet count ≥50 giga/L at inclusion.
- Patients with severe anemia and hemoglobin <70 g/L at baseline.
- Patient with intolerance or contraindication to oral or subcutaneous chelation therapy.
- Ferritinemia >1000 µg/L or hepatic iron concentration ≥7 mg/g or cardiac T2* <20 ms at inclusion.
- Patient able to understand (French-speaking) and comply with protocol, having signed informed consent.
Who cannot join
- Patients with primary hemochromatosis (transferrin saturation coefficient CS-Tf > 45%).
- Patients with a contraindication to the use of MEX-CD1: weight < 30 kg, iron deficiency.
- Patients with a known allergy or contraindication to heparin or citrate.
- Patients undergoing azacitidine or other chemotherapy (or considered as such) for myelodysplastic syndrome or myelofibrosis.
- Patient who received treatment with luspatercept or erythropoietin (EPO) during the month prior to inclusion.
- Patients with indications for allogeneic bone marrow transplantation.
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- Patients with a known allergy to shellfish (MEX-CD1 contains chitosan of animal origin) or to one of the other components of MEX-CD1.
- Patients with a peripheral vascular access that is difficult to access or that needs to be preserved.
- Patients participating in other interventional research that could interfere with the results of the study.
- Patients under legal protection or unable to express their consent.
- Patients under psychiatric care.
- Patient deprived of liberty by judicial or administrative decision.
- Pregnant or breast-feeding 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
- Recruiting
Hôpital Lyon Sud
Oullins-Pierre-Bénite, 69495
Auguste DARGENT, MD, PhD, +33 478 862 006, auguste.dargent@chu-lyon.fr
- Recruiting
Hôpital Lyon Sud
Oullins-Pierre-Bénite, 69495
Maël HEIBLIG, MD, PhD, +33 478 862 210, mael.heiblig@chu-lyon.fr
About this study
Official title: Feasibility, Tolerability and Efficacy of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis Intolerant of or Contraindicated to Oral or Subcutaneous Chelation Treatment.
In transfusion-dependent myelodysplastic syndromes patients, regular blood transfusions lead to iron overload, which can cause organ damage, hormonal imbalances, and increased infection risk, ultimately impacting patient survival. Standard oral iron chelation therapies can be intolerable for some patients due to adverse effects. The MEX-CD1 device (class III) could potentially offer an alternative for these patients by reducing serum iron levels through a novel, extracorporeal approach.
MEXIRON clinical investigation focuses on the use of MEX-CD1, a medical device designed for extracorporeal chelation therapy to reduce iron overload in patients suffering from transfusion-dependent myelodysplastic syndromes (MDS) and myelofibrosis.
Read more
MEXIRON aims to evaluate the device's use feasibility, safety, and effectiveness in reducing iron levels. Transfusions needs, patient experience and quality of life are also assessed.
Each enrolled patients will undergo three low-volume continuous veno-venous haemodialysis cycles within one week.
Following the three- haemodialysis cycles, patients will be monitored through on-site follow-up visits at 7 days, 28 days, and 90 days post-treatment to assess long-term effects.
- Conditions
- Myelodysplastic Syndrome, Myelofibrosis
- Being tested
- Low-volume continuous veno-venous haemodialysis with MEX-CD1 use
- Keywords
- Myelodysplastic syndrome, myelofibrosis, iron chelation therapy, haemodialysis
- Medical subject headings
- Myelodysplastic Syndromes, Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-volume continuous veno-venous haemodialysis with MEX-CD1 useDevice
MEX-CD1 is a hyper-chelating colloidal solution that can be added to the dialysate to be used in low-volume continuous veno-venous hemodialysis. Intervention includes 3 low-volume continuous veno-venous hemodialysis for a duration of 3h20 each. For non-hospitalized patients, the treatment is performed on an outpatient basis.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: low-volume continuous veno-venous haemodialysis with MEX-CD1 use | Experimental | Patients enrolled will benefit 3 consecutive cycle of low volume continuous veno-venous haemodialysis using MEX-CD1 treatment. Receives: Device: Low-volume continuous veno-venous haemodialysis with MEX-CD1 use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of MEX-CD1 on total iron chelation during a session epuration.
Quantity of iron values measured in the effluent bag (Hf) during each low-volume continuous veno-venous hemodialysis cycle
Measured: Day 4
Secondary outcomes (9)
Performance of MEX-CD1 on iron profile.
Amount of iron measured on the effluent line (H1, H2, Hf) during each Extracorporeal Purification session
Measured: Day 4
Performance of MEX-CD1 on iron profile.
Variations in iron, ferritin and transferrin values from the start until i) each low-volume continuous veno-venous hemodialysis cycle ending (Hf) and ii) after 3 low-volume continuous veno-venous hemodialysis cycles
Measured: Day 4
Safety of MEX-CD1 use
Assessment of adverse events during low-volume continuous veno-venous hemodialysis cycles and all follow up period.
Measured: week 16
Impact on blood products patient's needs.
Assessment on patient's red blood cells administration from the start of the first MEX-CD1 treatment until the follow-up ending.
Measured: week 16
Feasibility of MEX-CD1 use
Assessment of patient's proportion who will have performed i) the entire first low-volume continuous veno-venous hemodialysis cycle and ii) the whole weakly 3 consecutive cycles at the end of the third low-volume continuous veno-venous hemodialysis cycle.
Measured: Day 4
Patient's reported tolerability of low-volume continuous veno-venous hemodialysis cycle.
Patients tolerability assessment by Visual Analog Scales (VAS) on painful and asthenia feelings at the end of each low-volume continuous veno-venous hemodialysis cycle.
Measured: Day 4
Patient's reported quality of life.
Quality of life assessment by the Medical Outcome Study Short Form 12 from the inclusion visit until end of follow-up.
Measured: Week 16
Feasibility of MEX-CD1 use: treatment delivery ratio
Ratio of effective treatment time to programmed treatment time (200 minutes), expressed as a percentage for each treatment session.
Measured: End of each session (Sessions 1 to 3, up to Day 4)
Feasibility of MEX-CD1 use: blood volume processed
Total volume of blood processed (litres) during each treatment session as recorded by the dialysis monitor.
Measured: End of each session (Sessions 1 to 3, up to Day 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start6 Jan 2026
- Primary completion6 Jan 2027 (estimated)
- Study completion6 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility, prospective, monocentric, pilot clinical investigation
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- MEXBrain 13 avenue Albert Einstein 69100 Villeurbanne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781099
- Sponsor's protocol ID
- 69HCL23_0102
- Other IDs
- 2024-A02473-44
- Acronym
- MEXIRON
- Status last verified
- Oct 2026
- First submitted
- 8 Jan 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be made available upon reasonable request, together with the study protocol, statistical analysis plan and informed consent form. Data will be available beginning 6 months after publication of the main results and for 5 years. Requests should be addressed to the sponsor (Hospices Civils de Lyon, Direction de la Recherche Clinique et de l'Innovation). Access will require a methodologically sound proposal, approval by the sponsor and the study scientific committee, a signed data access agreement, and compliance with the General Data Protection Regulation and French regulations.