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NCT03798860 Clinical Trial

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

Lung Transplantation Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03798860
Other study ID # DSA-2018
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date December 2024

Study information
Verified date March 2023
Source Hannover Medical School
Contact Fabio Ius, Dr.
Phone +49 511-532-2125
Email Ius.Fabio@mh-hannover.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Single-arm, prospective observational study

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date December 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - all patients after lung transplantation with detection of donor-specific antibodies Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Germany Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery Hannover

Sponsors (1)
Lead Sponsor Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

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