Clinical Performance of the New Plasma Filter PX2 in TPE Treatments

The plasma filter is applied for a single use in extracorporeal blood purification therapy. The intended purpose is the separation of plasma from blood by filtration, in conditions, which are associated with increased concentration of plasma components where a rapid depletion slows down or stops a pathogenic process. The investigation involves the collection of treatment data of the new Plasma Filter PX2 in combination with the multiFiltrate and multiFiltratePRO in therapeutic plasma exchange (TPE) treatments. The multiFiltrate and multiFiltratePRO are devices for extracorporeal blood purification treatments. No further control treatments will be investigated in this one arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the new Plasma Filter PX2. No specific treatment schedule is defined by the study protocol. The TPE treatment is performed with the plasma filter PX2 (investigational device) according to clinical practice established in each of the participating centers and are prescribed at the discretion of the treating physician. The participation in the study will have no influence on the treatment plan. The documentation of the treatment includes the therapy up to the tenth (10th) treatment.

NCT Number	NCT06382675
Lead Sponsor	Fresenius Medical Care Deutschland GmbH Collaborators: Alcedis GmbH
Conditions	Autoimmune Diseases
Enrollment	46 participants
Start Date	2024-07-18
Primary Completion	2026-12 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2026-06-24