NCT03798860

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
• Phase: —
• Study type: Observational
• Enrollment: 340 (actual)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2018-10-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2019-01-10
• Last updated: 2026-03-25

Locations

1 site across 1 country: Germany