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NCT03474536 Clinical Trial

Quantitative Parameters of HLA-DQ Antibodies in Lung Transplantation

Lung Transplantation Clinical Trial

— AFFIHLA-P  

Official title:
Clinical Impact of Concentration and Affinity of HLA-DQ Antibodies in Lung Transplantation - AFFIHLA-P

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03474536
Other study ID # CHUBX 2017/35
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 14, 2018
Est. completion date December 13, 2024

Study information
Verified date May 2024
Source University Hospital, Bordeaux
Contact Jonathan Visentin, MD, Ph.D
Phone +33557 82 08 85
Email jonathan.visentin@chu-bordeaux.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim is to compare the quantitative parameters of de novo anti-HLA DQ Donor Specific Antibodies (DSA), determined at the time of their discovery by surface plasmon resonance (SPR), between recipients that developed a Chronic Lung Allograft Dysfunction (CLAD) for the 2 years following DSA apparition and those who did not. If concentration, kinetics and/or affinity parameters of anti-DQ DSA are associated with CLAD development, new, non-invasive prognostic biomarkers of humoral rejection in lung transplantation will be discovered .

Description:

After lung transplantation the production of de novo DSA directed against HLA-DQ molecules is associated with CLAD and graft loss. The most used assay for serum DSA detection is the Single Antigen Luminex® (SAG), which provides a semi-quantitative fluorescence value, the MFI, used as a surrogate of DSA "strength". But MFI is not perfectly associated with CLAD development. We developed a method using SPR allowing the concentration, kinetics (ka, kd) and affinity parameters (KD) of anti-DQ DSA to be determined. These quantitative parameters could represent biomarkers finely associated with CLAD. The way this parameters evolve (stability, increase or decrease) with time could also impact on DSA pathogenicity. We will compare the quantitative parameters of de novo anti-HLA DQ DSA, determined at the time of their discovery, between recipients that developed a CLAD for the 2 years following DSA apparition, and those who did not. The association between quantitative parameters of DSA and graft loss, their evolution and its association with CLAD and graft loss, and their correlation with SAG MFI will be also evaluated.

Recruitment information / eligibility
Status Recruiting
Enrollment 93
Est. completion date December 13, 2024
Est. primary completion date December 13, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 years and older - Patient transplanted between 01/01/2001 and 31/07/2016 - Patient with immunodominant anti-HLA DQ de novo DSA developed before 08/2016 - Patient for who sufficient remaining serum quantity is available in usual care biobank - non-opposition of the patient Exclusion Criteria: - preformed DSA at the transplantation; - Non immunodominant DQ DSA ; - Insufficient serum quantity in usual care biobank - Inability to determine the date of DSA apparition at around one year - opposition of the patient

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU Bordeaux Bordeaux
France Hôpital Marie Lannelongue Le Plessis-Robinson
France AP-HP Hôpital Bichat Paris
France Hôpital Européen Georges Pompidou Paris
France Hôpital Foch Suresnes

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary CLAD development CLAD development within the 2 years following DSA apparition 2 years
Secondary raft loss up to 5 years following DSA apparition Graft loss up to 5 years following DSA apparition, defined by re-transplantation or recipient's death 6 months, 1 year, 2 years, 5 years
Secondary CLAD development CLAD development 6 months following DSA apparition 6 months
Secondary CLAD development CLAD development 1 year following DSA apparition 1 year
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