Using a new plasma filter for blood purification in autoimmune diseases

Clinical Performance of the New Plasma Filter PX2 in Combination with the MultiFiltrate and MultiFiltratePRO in TPE Treatments

This study is testing a new plasma filter to see if it can improve blood purification treatments for people with autoimmune diseases.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fresenius Medical Care Deutschland GmbH (Industry-sponsored)
• Locations: 5 sites (Aschaffenburg, Bavaria and 4 other locations)
• Trial ID: NCT06382675 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the performance of the new Plasma Filter PX2 during therapeutic plasma exchange (TPE) treatments for patients with autoimmune diseases. The study collects treatment data using the PX2 filter in conjunction with the multiFiltrate and multiFiltratePRO devices, focusing on its effectiveness in separating plasma from blood. It is designed as a one-arm study to reflect real-world clinical practice without control treatments, allowing for empirical evidence to be gathered on the filter's performance. There is no specific treatment schedule defined, providing flexibility in the application of TPE.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who require therapeutic plasma exchange and can safely undergo the procedure with the PX2 filter.

Not a fit: Patients with known hypersensitivity to the materials in the PX2 filter or those with heparin allergies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the effectiveness of plasma exchange treatments for patients with autoimmune diseases.

How similar studies have performed: While this approach is being evaluated for the first time with the PX2 filter, similar studies using other plasma filters have shown promising results.

Eligibility criteria

Inclusion Criteria:

* Informed consent signed and dated by study patient and investigator/authorized physician
* Minimum age of 18 years
* Patients with an indication for a therapeutical plasma exchange
* Patients to be treated with the plasma filter PX2 in combination with the multiFiltrate or multiFiltratePRO
* No contraindication against systemic anticoagulation
* Ability to understand the nature and requirements of the study

Exclusion Criteria:

* Patients with known or suspected hypersensitivity to any of the materials of the PX2 plasma filter (Polysulfone, Polyvinylpyrrolidone, Polypropylene, Polyurethane, Silicone) and trial related products
* Patients suffering from a heparin allergy
* Patients with a prescription for TPE treatment with the completion of \< 0.8 PV and \> 2.0 PV
* Any conditions which could interfere with the patient's ability to comply with the study
* Women of childbearing age (\< 55 years) without effective means of contraception, pregnancy (pregnancy test will be conducted at start) or lactation period
* Participation in a different interventional clinical study during the preceding 30 days
* Previous participation in this investigation

Where this trial is running

Aschaffenburg, Bavaria and 4 other locations

• Klinikum Aschaffenburg-Alzenau — Aschaffenburg, Bavaria, Germany (Recruiting)
• Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum) — Munich, Bavaria, Germany (Recruiting)
• Städtisches Klinikum Braunschweig — Braunschweig, Lower Saxony, Germany (Recruiting)
• St. Vincenz Kliniken — Paderborn, North Rhine-Westphalia, Germany (Recruiting)
• Charité-Universitätsmedizin Berlin — Berlin, State of Berlin, Germany (Recruiting)

Study contacts

• Principal investigator: Stefan Büttner, Dr. med. — Klinikum Aschaffenburg-Alzenau
• Study coordinator: Manuela Stauss-Grabo, Dr.

Conditions Autoimmune Diseases; Therapeutical Plasma Exchange