Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine (SEPIAR)

Fresenius Medical Care (FMC)

Status

Completed

Conditions

Autoimmune Diseases

Treatments

Device: Immunoadsorber GLOBAFFIN®

Study type

Interventional

Funder types

Industry

Identifiers

NCT04078698

TA-IA-03-INT

Details and patient eligibility

About

Documentation of the safety and effectiveness profile of the CE-labelled immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.

Full 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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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