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Blood filter shows promise for autoimmune patients

NCT ID NCT04078698

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at a device called GLOBAFFIN that filters antibodies from the blood to help people with autoimmune diseases. It involved 34 adults and measured how much harmful antibodies were removed and if patients felt better. The goal was to see if the device is safe and works well in everyday medical practice.

What this could mean

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

Active substance
GLOBAFFIN immunoadsorber (a device that filters antibodies from the blood)
What this could lead to
If successful, this could confirm that the GLOBAFFIN device is a safe and effective way to manage autoimmune diseases by removing harmful antibodies.
What could go wrong
This is a small, completed observational study with only 34 patients, so results may not apply to everyone. It does not compare the device to other treatments, so its true benefit is uncertain.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

34 people

The number who actually took part.

Started

Sep 2019

Finished

Aug 2025

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.

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: * Minimum age of 18 years * Informed consent signed and dated by study patient and investigator/authorised physician * Ability to understand the nature and requirements of the study * Treatment with one of the immunoadsorber system GLOBAFFIN® according to the intended use. Exclusion Criteria: General: * Any condition which could interfere with the patient's ability to comply with the study * In case of female patients: pregnancy or lactation period (if patient is ≥ 55 years old or have been surgically sterilized, a negative pregnancy test is not required) * Participation in an interventional clinical study during the preceding 30 days. * Participation in an interventional clinical study with pharmacological active substances (e.g. therapeutic antibodies) during the preceding 60 days. * Any deviation from the intended use Study-specific: Any contraindication listed in the valid instruction for use: * Hypersensitivity or allergy against any materials used in either the immunoadsorber column or the extracorporeal circuit * Inability to withstand the stress of an extracorporeal treatment procedure due to their age, their physical developments or their clinical constitution * Previously demonstrated hypersensitivity associated with therapeutic apheresis * No suitable anticoagulation treatment, such as due to known hypersensitivity to heparin or ACD-A * Haemorrhagic diathesis in which extracorporeal apheresis procedures and anticoagulation performed have a high bleeding hazard * Severe cardiovascular disease, so that extracorporeal treatment is not possible * Acute, systemic infection

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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

  • Diakonissenkrankenhaus Flensburg

    Flensburg, 24939, Germany

  • Städtisches Klinikum Braunschweig

    Braunschweig, Lower Saxony, 38126, Germany

  • University of Ulm - Department of Neurology

    Ulm, 89081, Germany

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