Clinical Performance of the New Plasma Filter PX2 in TPE Treatments (plasmaFlux)

March 13, 2025 updated by: Fresenius Medical Care Deutschland GmbH

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Bavaria
    • Niedersachsen
      • Braunschweig, Niedersachsen, Germany, 38126
        • Recruiting
        • Städtisches Klinikum Braunschweig
        • Contact:
    • Nordrhein-Westfalen
      • Paderborn, Nordrhein-Westfalen, Germany, 33098

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Therapeutic Plasma Exchange (TPE)
Patients with indication for TPE treatment according to American Society for Apheresis (ASFA) guideline
Device: Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
on average 7 weeks depending on on the indication, frequency and number of treatments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Medical Care Deutschland GmbH

Collaborators

KLIFO GmbH

Investigators

  • Principal Investigator: Stefan Büttner, Dr. med., Klinikum Aschaffenburg-Alzenau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA-PF-01-DE
  • CIV-23-11-044643 (Other Identifier: Unique identification number EUDAMED)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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