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

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ClinicalTrials.gov Identifier: NCT04078698
Recruitment Status : Recruiting
First Posted : September 5, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH

Brief Summary:
Documentation of the safety and effectiveness profile of the CE-labelled immunoadsorbers GLOBAFFIN®, LIGASORB® and IgEnio® in clinical routine according to their intended use.

Condition or disease Intervention/treatment
Autoimmune Diseases Device: Immunoadsorbers GLOBAFFIN®, LIGASORB® and IgEnio®

Detailed Description:

The objective of the study is the documentation of the safety and effectiveness profile of the CE-labeled immunoadsorbers GLOBAFFIN®, LIGASORB® and IgEnio® in clinical routine according to their intended use.

The primary objective for the IgG adsorber GLOBAFFIN® and LIGASORB® is the estimation of the mean relative reduction in total IgG from pre- to post-treatment per treatment session. The primary objective for the IgE adsorber IgEnio® is the estimation of the mean relative reduction in total IgE from pre- to post-treatment per treatment session.


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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorbers GLOBAFFIN® and LIGASORB® and IgE Immunoadsorber IgEnio® in Clinical Routine (SEPIAR)
Actual Study Start Date : September 5, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Immunoadsorbers GLOBAFFIN®, LIGASORB® and IgEnio®
    Documentation of the treatment with one of the immunoadsorbers GLOBAFFIN®, LIGASORB® or IgEnio® depending on the patient's underlying disease


Primary Outcome Measures :
  1. Relative reduction in total IgG from pre- to post-treatment (for GLOBAFFIN and LIGASORB treatments) [ Time Frame: 5 years ]
  2. Relative reduction in total IgE from pre- to post-treatment(for IgEnio treatments) [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with one of the immunoadsorbers GLOBAFFIN®, LIGASORB® or IgEnio® according to the intended use and to clinical routine protocols or with planned treatments (first-use) with one of the immunoadsorbers according to the intended use and to clinical routine protocols.
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 systems GLOBAFFIN®, LIGASORB®, IgEnio® according to the intended use.

Exclusion Criteria:

General:

  • Any condition which could interfere with the patient's ability to comply with the study
  • Pregnancy or lactation period
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04078698


Contacts
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Contact: Manuela Stauss-Grabo, Dr. +49 6172 609 5248 Manuela.Stauss-Grabo@fmc-ag.com
Contact: Mareike Giefer +49 6172 609 2263 Mareike.Giefer@fmc-ag.com

Locations
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Germany
Städtisches Klinikum Braunschweig Not yet recruiting
Braunschweig, Niedersachsen, Germany, 38126
Contact: Jan T. Kielstein, Prof. Dr.         
Diakonissenkrankenhaus Flensburg Recruiting
Flensburg, Germany, 24939
Contact: W Ries, MD         
Sponsors and Collaborators
Fresenius Medical Care Deutschland GmbH
Investigators
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Principal Investigator: Jan T. Kielstein, Prof. Dr. Städtisches Klinikum Braunschweig

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Responsible Party: Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier: NCT04078698     History of Changes
Other Study ID Numbers: TA-IA-03-INT
First Posted: September 5, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fresenius Medical Care Deutschland GmbH:
Therapeutic apheresis
Immune apheresis
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases