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NCT Number: NCT06382675

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.

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Key information

Conditions

Autoimmune Diseases Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Aschaffenburg-Alzenau, Aschaffenburg, Bavaria, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2

Device

230 evaluable TPE treatments will be documented in the study (with an average of 5-7 TPE treatments per patient this corresponds to approximately 46 patients)

Primary outcomes

Analysis of TPE treatments with the Plama Filter PX2

Time frame: on average 7 weeks depending on on the indication, frequency and number of treatments

Investigation of clinical performance of the new plasma filter PX2 by assessing the completion of the prescribed plasma volume (PV) in ≥ 75% of all TPE procedures

Study contacts

Contact information is provided by the study sponsor or research team.

Jana Schmitt

CONTACT

[email protected]

+4961722686305

Manuela Stauss-Grabo, Dr.

CONTACT

[email protected]

+49 1525 469 1929

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Industry

Collaborators

Alcedis GmbH

Registry information

Official study title

Clinical Performance of the New Plasma Filter PX2 in Combination With the multiFiltrate and multiFiltratePRO in TPE Treatments

Acronym: plasmaFlux

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Apr 24, 2024
Registry last updated: Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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