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Can a Blood-Cleaning device hit its plasma exchange targets?

NCT ID NCT06272084

Disease control Sponsor: Fresenius Medical Care Deutschland GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers review past therapeutic plasma exchange treatments performed with the multiFiltratePRO, a device that cleans blood outside the body. The study looks at records from people with autoimmune diseases who weighed at least 40 kg and received this treatment between 2019 and 2023. The main question is whether the device delivered the prescribed amount of exchanged plasma in more than 70% of sessions, matching current guideline targets.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
therapeutic plasma exchange using the multiFiltratePRO device
What this could lead to
If the device reliably delivers the prescribed plasma exchange volume, doctors could have clearer evidence that it meets guideline targets for treating autoimmune diseases.
What could go wrong
This is a retrospective review of past treatments at a single device maker's data, not a controlled comparison. The findings may not apply to other centers, other devices, or patients treated differently.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with indication for TPE treatment according to ASFA (American Society for Apheresis) guideline treated with TPE between January 2019 and October 2023.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

autoimmune disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune diseases

Contacts and locations

Locations

  • Charité-Universitätsmedizin Berlin

    Berlin, State of Berlin, 13353, Germany

  • Klinikum Aschaffenburg-Alzenau

    Aschaffenburg, Bavaria, 63739, Germany

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080, Germany

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