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Completed

NCT Number: NCT03798860

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

Single-arm, prospective observational study

Completed

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Hanover, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Blood samples

Diagnostic Test

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

Primary outcomes

  1. Donor-specific Antibodies Clearance

    Time frame: 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 outcomes

  1. Graft survival

    Time frame: 1, 3, 5 years

    Graft survival is defined as freedom from mortality and re-transplantation

  2. Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD)

    Time frame: 1, 3, 5 years

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2019
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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