Trial document




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  DRKS00005097

Trial Description

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Title

Safety, Efficacy and Clinical Outcome of the Immunosorba® and GLOBAFFIN® System

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Trial Acronym

IA-NIS Study

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URL of the Trial

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Brief Summary in Lay Language

The goal of the study is to increase the knowledge about the Immunosorba® and GLOBAFFIN®- column in respect to indication efficiency, handling and tolerability under routine clinical circumstances.


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Brief Summary in Scientific Language

Documentation of efficiency, device induced adverse and serious adverse effects, indication and outcome with immune apheresis using the Immunosorba® and GLOBAFFIN® columns

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005097
  •   2013/07/16
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  •   no
  •   Approved
  •   S-071/2013, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   G04.8 -  Other encephalitis, myelitis and encephalomyelitis
  •   L10.0 -  Pemphigus vulgaris
  •   G70.0 -  Myasthenia gravis
  •   G61.0 -  Guillain-Barré syndrome
  •   HLA-Immunisation
  •   T86.9 -  Failure and rejection of unspecified transplanted organ and tissue
  •   10000206: AB0 inkompability in transplantation
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Interventions/Observational Groups

  •   Prospective, observational, multicentric study of patients commonly treated with the Immunosorba®- or the GLOBAFFIN®-System, respectively.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Reduction of IgG-concentration in blood during one apheresis session, pre,post

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Secondary Outcome

Immunglobulin (IgM, IgA) reduction, Reduction of specific antibodies (as measured)during one apheresis session, pre,post;
Indication of immune apheresis ; clinical outcome using disease-specific questionnaire from start of apheresis treatment until 12 months later.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2013/07/08
  •   80
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Signed informed consent and treatment with Immunosorba®- bzw. GLOBAFFIN®-system

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Exclusion Criteria

Patient unable to consent or patients less than 18 years

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Addresses

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    • Fresenius Medical Care Deutschland GmbH
    • Else-Kröner-Str. 1
    • 61352  Bad Homburg
    • Germany
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    • Fresenius Medical Care Deutschland GmbH
    • Ms.  Mareike  Giefer 
    • Else-Kröner-Str. 1
    • 61352  Bad Homburg
    • Germany
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    • Nierenzentrum Heidelberg Abteilung Dialyse
    • Mr.  PD Dr.  Christian  Morath 
    • Im Neuenheimer Feld 162
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Fresenius Medical Care Deutschland GmbH
    • Else-Kroener-Str. 1
    • 61352  Bad Homburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/04/26
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.