Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03474536
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2018-03-05
Brief Title:
Quantitative Parameters of HLA-DQ Antibodies in Lung Transplantation
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Clinical Impact of Concentration and Affinity of HLA-DQ Antibodies in Lung Transplantation - AFFIHLA-P
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AFFIHLA-P
Brief 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 andor 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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None