MEXIRON
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.
Sponsor study identifier
Secondary identifiers
OTHER · ID-RCB
interventional
13
1 country
2
Study Start
January 6, 2026
Actual (reported)Primary Completion
January 6, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 6, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 6, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 8, 2025
Actual (reported)January 17, 2025
Actual (reported)January 6, 2026
Actual (reported)January 6, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 6, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Day 4
Performance of MEX-CD1 on iron profile.
Day 4
Performance of MEX-CD1 on iron profile.
Day 4
Safety of MEX-CD1 use
week 16
Impact on blood products patient's needs.
week 16
Feasibility of MEX-CD1 use
Day 4
Exploratory ancillary outcome: trace metal quantification
From inclusion to Day 28
Patients enrolled will benefit 3 consecutive cycle of low volume continuous veno-venous haemodialysis using MEX-CD1 treatment.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hôpital Lyon Sud
Oullins-Pierre-Bénite, 69495, France
Hôpital Lyon Sud
Oullins-Pierre-Bénite, 69495, France
First Submitted
January 8, 2025
First Posted
January 17, 2025
Study Start
January 6, 2026
Actual (reported)Primary Completion
January 6, 2027
Evaluation of a Question Prompt List for Patients With Myelodysplastic Syndromes (QPL-MDS)
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 6, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 13, 2026
Record last verified: 2026-10
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.
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Source: ClinicalTrials.gov.
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