Autoimmune DiseasesSEPIARNCT04078698
Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine
A study testing Immunoadsorber GLOBAFFIN® in people with Autoimmune Diseases, run by Fresenius Medical Care Deutschland GmbH at 3 sites in Germany.
Trial summary
Documentation of the safety and effectiveness profile of the CE-labelled immunoadsorber GLOBAFFIN® in clinical routine according to their intended use. 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?
- Immunoadsorber GLOBAFFIN®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesGermany
- Study dates
- 5 Sep 2019to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Städtisches Klinikum Braunschweig
Braunschweig, Lower Saxony, 38126
Diakonissenkrankenhaus Flensburg
Flensburg, 24939
University of Ulm - Department of Neurology
Ulm, 89081
About this study
Official title: Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine (SEPIAR)
Documentation of the safety and effectiveness profile of the CE-labelled immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.
Read the detailed description
The objective of the study is the documentation of the safety and effectiveness profile of the CE-labeled immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.
The primary objective for the IgG adsorber GLOBAFFIN® is the estimation of the mean relative reduction in total IgG from pre- to post-treatment per treatment session.
- Conditions
- Autoimmune Diseases
- Being tested
- Immunoadsorber GLOBAFFIN®
- Keywords
- Therapeutic apheresis, Immune apheresis
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoadsorber GLOBAFFIN®Device
Documentation of the treatment with one of the immunoadsorber GLOBAFFIN® depending on the patient's underlying disease
| Study group | Role | What they receive |
|---|---|---|
| Treatment with the IgG immunoadsorber GLOBAFFIN® | Experimental | Treatment with the IgG immunoadsorber GLOBAFFIN® in clinical routine according to their intended use. Receives: Device: Immunoadsorber GLOBAFFIN® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative reduction in total IgG from pre- to post-treatment for GLOBAFFIN®
Measured: 5 years
Secondary outcomes (2)
Mean relative reduction in disease-specific IgG, total IgM and total IgA
Measured: 5 years
Clinical effect of the treatment measured by the physician's judgement as well as indication specific scores
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start5 Sep 2019
- Primary completion30 May 2025
- Study completion15 Aug 2025
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
- Prospective, multi-centre, open-label, non-comparative, interventional study
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alcedis GmbH
- Responsible party
- Sponsor
- Investigators
- Jan T. Kielstein, Prof. Dr., Principal investigator, Academic Teaching Hospital Braunschweig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078698
- Sponsor's protocol ID
- TA-IA-03-INT
- Acronym
- SEPIAR
- Status last verified
- Aug 2025
- First submitted
- 2 Sep 2019
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine (SEPIAR)
- ClinicalTrials.gov ID
- NCT04078698
- Acronym / sponsor ID
- SEPIAR / TA-IA-03-INT
- Conditions
- Autoimmune Diseases
- Keywords
- Therapeutic apheresis, Immune apheresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Alcedis GmbH
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 6 Sep 2019 (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.
Documentation of the safety and effectiveness profile of the CE-labelled immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.
Detailed description
The objective of the study is the documentation of the safety and effectiveness profile of the CE-labeled immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.
The primary objective for the IgG adsorber GLOBAFFIN® is the estimation of the mean relative reduction in total IgG from pre- to post-treatment per treatment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multi-centre, open-label, non-comparative, interventional study
| Arm | Type | Receives |
|---|---|---|
| Treatment with the IgG immunoadsorber GLOBAFFIN® | Experimental | Device: Immunoadsorber GLOBAFFIN®Treatment with the IgG immunoadsorber GLOBAFFIN® in clinical routine according to their intended use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Immunoadsorber GLOBAFFIN®Documentation of the treatment with one of the immunoadsorber GLOBAFFIN® depending on the patient's underlying disease | Device | Treatment with the IgG immunoadsorber GLOBAFFIN® |
Primary outcome
Relative reduction in total IgG from pre- to post-treatment for GLOBAFFIN®
Time frame: 5 years
2 secondary outcomes
Mean relative reduction in disease-specific IgG, total IgM and total IgA
Time frame: 5 years
Clinical effect of the treatment measured by the physician's judgement as well as indication specific scores
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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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.
Jan T. Kielstein, Prof. Dr. principal investigator
Academic Teaching Hospital Braunschweig
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunoadsorber GLOBAFFIN® in people with 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 15 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: finished, as of the sponsor's last update on 4 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relative reduction in total IgG from pre- to post-treatment for GLOBAFFIN® (time frame: 5 years). 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 4 Sep 2025.