Evaluating the safety and effectiveness of GLOBAFFIN® for autoimmune diseases
Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine (SEPIAR)
This study is testing if GLOBAFFIN® is safe and effective for treating autoimmune diseases by looking at how it affects certain antibody levels in patients aged 18 and older.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fresenius Medical Care Deutschland GmbH Industry-sponsored |
| Locations | 3 sites (Braunschweig, Niedersachsen and 2 other locations) |
| Trial ID | NCT04078698 on ClinicalTrials.gov |
What this trial studies
This study aims to document the safety and effectiveness profile of the immunoadsorber GLOBAFFIN® in clinical practice for patients with autoimmune diseases. The primary objective is to estimate the mean relative reduction in total IgG levels from pre- to post-treatment after each session. Patients aged 18 and older who meet specific inclusion criteria will receive treatment with GLOBAFFIN® according to its intended use. The study will follow a structured approach to ensure compliance and accurate documentation of results.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with autoimmune diseases who can provide informed consent.
Not a fit: Patients with contraindications to the GLOBAFFIN® treatment or those currently participating in other interventional studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a new therapeutic option for patients suffering from autoimmune diseases by effectively reducing IgG levels.
How similar studies have performed: Other studies have shown promising results with similar immunoadsorption techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Braunschweig, Niedersachsen and 2 other locations
- Städtisches Klinikum Braunschweig — Braunschweig, Niedersachsen, Germany (Recruiting)
- Diakonissenkrankenhaus Flensburg — Flensburg, Germany (Recruiting)
- University of Ulm - Department of Neurology — Ulm, Germany (Recruiting)
Study contacts
- Principal investigator: Jan T. Kielstein, Prof. Dr. — Academic Teaching Hospital Braunschweig
- Study coordinator: Manuela Stauss-Grabo, Dr.
- Email: Manuela.Stauss-Grabo1@FreseniusMedicalCare.com
- Phone: +49 6172 609 5248
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.