Clinical Performance of the New Plasma Filter PX2 in TPE Treatments

Autoimmune Diseases Clinical Trial

— plasmaFlux  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06382675
• Other study ID #: TA-PF-01-DE
• Secondary ID: CIV-23-11-044643
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: Manuela Stauss-Grabo, Dr.
• Phone: +49 1525 469 1929
• Email: Manuela.Stauss-Grabo1[@]freseniusmedicalcare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: March 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 < 1.0 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

Related Conditions & MeSH terms

• Autoimmune Diseases

Intervention

Device:
• Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2
272 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)

Locations

Country	Name	City	State
Germany	Klinikum Aschaffenburg-Alzenau	Aschaffenburg	Bavaria
Germany	Städtisches Klinikum Braunschweig	Braunschweig	Niedersachsen

Sponsors (2)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH	KLIFO GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 = 70% of all TPE procedures	on average 7 weeks depending on on the indication, frequency and number of treatments