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

Monitoring of Donor-specific Antibodies (DSA) After Combined Treatment With Immunoglobulin A and Immunoglobulin M-enriched Intravenous Human Immunoglobulins and Plasmapheresis and Rituximab in Lung Transplantation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03798860
Enrollment
340
Registered
2019-01-10
Start date
2018-10-01
Completion date
2025-12-31
Last updated
2026-03-25

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

Conditions

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

Brief summary

Single-arm, prospective observational study

Detailed description

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.

Interventions

DIAGNOSTIC_TESTblood samples

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

Sponsors

Hannover Medical School
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Donor-specific Antibodies Clearance6, 12, 18, 24 monthsThe DSA clearance is defined as absence of DSA in the Luminex test, which is performed every 6 months after treatment end.

Secondary

MeasureTime frameDescription
Graft survival1, 3, 5 yearsGraft survival is defined as freedom from mortality and re-transplantation
Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD)1, 3, 5 years—

Countries

Germany

Contacts

PRINCIPAL_INVESTIGATORFabio Ius, Dr.

Hannover Medical School

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026