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

Recruiting

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

• Registration Number: NCT03798860
• Lead Sponsor: Hannover Medical School

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.

Study Timeline

• Study First Submitted: 2018-09-26
• Study Start: 2018-10-01
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Donor-specific Antibodies Clearance	6, 12, 18, 24 months	The DSA clearance is defined as absence of DSA in the Luminex test, which is performed every 6 months after treatment end.

Secondary Outcome Measures

Name	Time	Method
Graft survival	1, 3, 5 years	Graft 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

Trial Locations

Locations (1)

Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery; 🇩🇪 Hannover, Germany