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

Safety, Efficacy and Clinical Outcome of the Immunosorba® and GLOBAFFIN® System - IA-NIS Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00005097

Enrollment

Registered

2013-07-16

Start date

2013-07-08

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HLA-Immunisation MedDRA - 10000206: AB0 inkompability in transplantation G04.8 L10.0 G70.0 G61.0 T86.9

Interventions

Group 1: Prospective, observational, multicentric study of patients commonly treated with the Immunosorba®- or the GLOBAFFIN®-System, respectively.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Patient unable to consent or patients less than 18 years

Design outcomes

Primary

Measure	Time frame
Reduction of IgG-concentration in blood during one apheresis session, pre,post	—

Secondary

Measure	Time frame
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.	—

Countries

Germany

Contacts

Public ContactChristian Morath

Nierenzentrum Heidelberg Abteilung Dialyse

Christian.Morath@med.uni-heidelberg.de06221/5635298

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026