Autoimmune DiseasesTPEoptNCT06272084
Analysis of TPE Treatments With multiFiltratePRO
An observational study of Autoimmune Diseases, run by Fresenius Medical Care Deutschland GmbH at 3 sites in Germany.
Trial summary
Analysis of therapeutic plasma exchange (TPE) treatments to assess the performance of the TPE mode of multiFiltratePRO based on the successful exchange of plasma from whole blood. The multiFiltratePRO is a device for extracorporeal blood purification treatments. 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) option of multiFiltratePRO
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 3 sitesGermany
- Study dates
- 22 May 2024to Dec 2026
- Phase
- Observational
- 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
Study population: Patients with indication for TPE treatment according to ASFA (American Society for Apheresis) guideline treated with TPE between January 2019 and October 2023.
Who may be able to join
- Body weight ≥40kg irrespective of the age
- Patients with indication for TPE treatment according to ASFA guideline
- Patients have been treated with TPE between January 2019 and October 2023
- Availability of at least 50% of the parameters to be documented for the patient
Who cannot join
- Participation in an interventional clinical study during the retrospectively collected TPE treatment data
- Previous documentation within this study
- Simultaneous use of another filter for additional therapy form
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Klinikum Aschaffenburg-Alzenau
Aschaffenburg, Bavaria, 63739
Charité-Universitätsmedizin Berlin
Berlin, State of Berlin, 13353
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080
About this study
Analysis of therapeutic plasma exchange (TPE) treatments to assess the performance of the TPE mode of multiFiltratePRO based on the successful exchange of plasma from whole blood. The multiFiltratePRO is a device for extracorporeal blood purification treatments.
Read the detailed description
The study is a retrospective, open, non-comparative, multi-centric PMCF study. The investigational device has CE approval. The investigation involves the retrospective collection of treatment data for the TPE treatment mode from the medical records. 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 TPE mode of the multiFiltratePRO system.
The site will document the treatment data of patients with an indication for the TPE treatment who had been treated with the investigational devices under the TPE treatment mode between 2019 and October 2023 in chronological order.
- Conditions
- Autoimmune Diseases
- Being tested
- Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO
- Keywords
- Therapeutical Plasma Exchange, ASFA Guideline
- 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) option of multiFiltratePRODevice
Retrospective Data Analysis of TPE treatments with multiFiltratePRO
| Study group | Role | What they receive |
|---|---|---|
| TPE Treatments | Patients with indication for TPE treatment according to American Society for Apheresis (ASFA) guideline Receives: Device: Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of exchange plasma (prescribed vs achieved exchange volume)
Statistical analysis is performed on retrospective data (Treatments between 2019 and October 2023). Primary goal of the study is to prove that the prescribed therapeutic plasma exchange rate during treatment was achieved in > 70% of treatments and therefore was in alignment with current guidelines.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start22 May 2024
- Primary completion22 Feb 2026
- Study completionDec 2026 (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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- X-act Cologne Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Stefan Büttner, Dr. med., Principal investigator, Klinikum Aschaffenburg-Alzenau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272084
- Sponsor's protocol ID
- CRRT-TPE-01-DE
- Acronym
- TPEopt
- Status last verified
- Sep 2026
- First submitted
- 5 Feb 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of TPE Treatments With multiFiltratePRO
- ClinicalTrials.gov ID
- NCT06272084
- Acronym / sponsor ID
- TPEopt / CRRT-TPE-01-DE
- Conditions
- Autoimmune Diseases
- Keywords
- Therapeutical Plasma Exchange, ASFA Guideline
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- X-act Cologne Clinical Research GmbH
- Study start
- 22 May 2024 (actual)
- Primary completion
- 22 Feb 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Feb 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.
Analysis of therapeutic plasma exchange (TPE) treatments to assess the performance of the TPE mode of multiFiltratePRO based on the successful exchange of plasma from whole blood. The multiFiltratePRO is a device for extracorporeal blood purification treatments.
Detailed description
The study is a retrospective, open, non-comparative, multi-centric PMCF study. The investigational device has CE approval. The investigation involves the retrospective collection of treatment data for the TPE treatment mode from the medical records. 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 TPE mode of the multiFiltratePRO system.
The site will document the treatment data of patients with an indication for the TPE treatment who had been treated with the investigational devices under the TPE treatment mode between 2019 and October 2023 in chronological order.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPE Treatments | – | Device: Therapeutic Plasma Exchange (TPE) option of multiFiltratePROPatients 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
- Study population
- Patients with indication for TPE treatment according to ASFA (American Society for Apheresis) guideline treated with TPE between January 2019 and October 2023.
Key inclusion criteria (4 listed)
- Body weight ≥40kg irrespective of the age
- Patients with indication for TPE treatment according to ASFA guideline
- Patients have been treated with TPE between January 2019 and October 2023
- Availability of at least 50% of the parameters to be documented for the patient
Key exclusion criteria (3 listed)
- Participation in an interventional clinical study during the retrospectively collected TPE treatment data
- Previous documentation within this study
- Simultaneous use of another filter for additional therapy form
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) option of multiFiltratePRORetrospective Data Analysis of TPE treatments with multiFiltratePRO | Device | TPE Treatments |
Primary outcome
Total amount of exchange plasma (prescribed vs achieved exchange volume)
Time frame: through study completion, an average of 1 year
Statistical analysis is performed on retrospective data (Treatments between 2019 and October 2023). Primary goal of the study is to prove that the prescribed therapeutic plasma exchange rate during treatment was achieved in > 70% of treatments and therefore was in alignment with current guidelines.
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 11 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Stefan Büttner, Dr. med. principal investigator
Klinikum Aschaffenburg-Alzenau
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Diseases, run by Fresenius Medical Care Deutschland GmbH at 3 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of exchange plasma (prescribed vs achieved exchange volume) (time frame: through study completion, an average of 1 year). 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 11 Sep 2026.