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

Single-arm, prospective observational study

Study Overview

• Status: Completed
• Conditions: Lung Transplantation; Donor-specific Anti-human Leukocyte Antigen(HLA) Antibodies
• Intervention / Treatment: Diagnostic test: blood samples

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 Type: Observational
• Enrollment (Actual): 340

Contacts and Locations

Study Locations

• Germany
  • Hanover, Germany
    • Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients after lung transplantation with detection of donor-specific antibodies

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft survival	Graft survival is defined as freedom from mortality and re-transplantation	1, 3, 5 years
Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD)		1, 3, 5 years

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Fabio Ius, Dr., Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: DSA-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No