Monitoring of Donor-specific Antibodies After Treatment with Immunoglobulins, Plasmapheresis and Rituximab in Lung Transplantation

NCT ID: NCT03798860

Last Updated: 2024-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2026-12-31

Brief Summary

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Single-arm, prospective observational study

Detailed Description

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This is an observational study to monitor the treatment of donor-specific antibodies in lung transplant recipients with detection of donor-specific antibodies. All consented subjects will be approached for participation. The study will evaluate the effectiveness of the treatment protocol of donor-specific antibodies with Immunoglobulins or combined treatment with Immunoglobulins, Plasmapheresis and Rituximab after lung transplantation.

Conditions

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Lung Transplantation Donor-specific Anti-human Leukocyte Antigen(HLA) Antibodies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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blood samples

For performing the Luminex solid phase assay (SPA) test, 7.5 ml of patient whole blood are collected from a peripheral vein.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* all patients after lung transplantation with detection of donor-specific antibodies

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabio Ius, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery

Hanover, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Fabio Ius, Dr.

Role: CONTACT

+49 511-532-2125

Susanne Freyt

Role: CONTACT

+49 511-532-3450

Facility Contacts

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Susanne Freyt

Role: primary

+49 511-532-3450

Fabio Ius, Dr.

Role: backup

Other Identifiers

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DSA-2018

Identifier Type: -

Identifier Source: org_study_id

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