Autoimmune DiseasesplasmaFluxNCT06382675
Clinical Performance of the New Plasma Filter PX2 in TPE Treatments
A study testing Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2 in people with Autoimmune Diseases, run by Fresenius Medical Care Deutschland GmbH at 7 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 7 sitesGermany
- Study dates
- 18 Jul 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Germany7 sites, 7 recruiting
- Recruiting
Klinikum Aschaffenburg-Alzenau
Aschaffenburg, Bavaria, 63739
Stefan Büttner, Dr. med., Stefan.buettner@klinikum-ab-alz.de
- Recruiting
Charité-Universitätsmedizin Berlin
Berlin, State of Berlin, 13353
Eva Schrezenmeier, Dr. med., Eva-vanessa.schrezenmeier@charite.de
- Recruiting
Städtisches Klinikum Braunschweig
Braunschweig, Lower Saxony, 38126
Gabriele Eden, Dr. med., g.eden@skbs.de
- Recruiting
Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum)
Munich, Bavaria, 81377
Michael Fischereder, Prof. Dr., Michael.Fischereder@med.uni-muenchen.de
- Recruiting
St. Vincenz Kliniken
Paderborn, North Rhine-Westphalia, 33098
Alexander Weidemann, Dr. med., a.weidemann@vincenz.de
- Recruiting
Universitätsklinikum Ulm
Ulm, 89081
Johannes Dorst, Prof. Dr. med., +497311775285, Johannes.dorst@uni-ulm.de
- Recruiting
Universitätsklinikum Würzburg
Würzburg, 97080
Anna Herzog, Dr. med., +49931 201 39914, Herzog_A1@ukw.de
About this study
Official title: 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.
- Conditions
- Autoimmune Diseases
- Being tested
- Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2
- Keywords
- Therapeutical Plasma Exchange
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2Device
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)
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Plasma Exchange (TPE) | Other | Patients with indication for TPE treatment according to American Society for Apheresis (ASFA) guideline Receives: Device: Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: on average 7 weeks depending on on the indication, frequency and number of treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start18 Jul 2024
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional, single arm, multi-centric, open-label
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alcedis GmbH
- Responsible party
- Sponsor
- Investigators
- Stefan Büttner, Dr. med., Principal investigator, Klinikum Aschaffenburg-Alzenau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382675
- Sponsor's protocol ID
- TA-PF-01-DE
- Other IDs
- CIV-23-11-044643
- Acronym
- plasmaFlux
- Status last verified
- Jun 2026
- First submitted
- 22 Feb 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of the New Plasma Filter PX2 in Combination With the multiFiltrate and multiFiltratePRO in TPE Treatments
- ClinicalTrials.gov ID
- NCT06382675
- Acronym / sponsor ID
- plasmaFlux / TA-PF-01-DE
- Conditions
- Autoimmune Diseases
- Keywords
- Therapeutical Plasma Exchange
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Alcedis GmbH
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional, single arm, multi-centric, open-label
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Plasma Exchange (TPE) | Other | Device: Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2Patients with indication for TPE treatment according to American Society for Apheresis (ASFA) guideline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2230 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) | Device | Therapeutic Plasma Exchange (TPE) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Autoimmune Diseases
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan Büttner, Dr. med. principal investigator
Klinikum Aschaffenburg-Alzenau
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2 in people with Autoimmune Diseases, run by Fresenius Medical Care Deutschland GmbH at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manuela Stauss-Grabo, Dr. (+49 1525 469 1929, Manuela.Stauss-Grabo1@freseniusmedicalcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.