Clinical Performance of the New Plasma Filter PX2 in TPE Treatments

NCT06382675 | Recruiting DMC

• 2 other identifiers: TA-PF-01-DECIV-23-11-044643
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Autoimmune Diseases

Keywords

Therapeutical Plasma Exchange

Outcome Measures

Primary Outcomes (1)

• Analysis of TPE treatments with the Plama Filter PX2

  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

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

Study Arms (1)

Therapeutic Plasma Exchange (TPE)

OTHER

Patients with indication for TPE treatment according to American Society for Apheresis (ASFA) guideline

Device: Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2

Interventions

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)

Therapeutic Plasma Exchange (TPE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead
• KLIFO GmbH: collaborator

Study Sites (5)

Klinikum Aschaffenburg-Alzenau

Aschaffenburg, Bavaria, 63739, Germany

RECRUITING

Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum)

Munich, Bavaria, 81377, Germany

RECRUITING

Städtisches Klinikum Braunschweig

Braunschweig, Lower Saxony, 38126, Germany

RECRUITING

St. Vincenz Kliniken

Paderborn, North Rhine-Westphalia, 33098, Germany

RECRUITING

Charité-Universitätsmedizin Berlin

Berlin, State of Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Stefan Büttner, Dr. med.

  Klinikum Aschaffenburg-Alzenau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuela Stauss-Grabo, Dr.

CONTACT

+49 1525 469 1929; Manuela.Stauss-Grabo1@freseniusmedicalcare.com

Jana Schmitt

CONTACT

+4961722686305; jana.schmitt@freseniusmedicalcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Interventional, single arm, multi-centric, open-label

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: April 24, 2024
• Study Start: July 18, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)