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Completed

NCT Number: NCT03474536

Quantitative Parameters of HLA-DQ Antibodies in Lung Transplantation

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 .

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Bordeaux, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. CLAD development

    Time frame: 2 years

    CLAD development within the 2 years following DSA apparition

Secondary outcomes

  1. raft loss up to 5 years following DSA apparition

    Time frame: 6 months, 1 year, 2 years, 5 years

    Graft loss up to 5 years following DSA apparition, defined by re-transplantation or recipient's death

  2. CLAD development

    Time frame: 6 months

    CLAD development 6 months following DSA apparition

  3. CLAD development

    Time frame: 1 year

    CLAD development 1 year following DSA apparition

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: AFFIHLA-P

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Mar 22, 2018
Registry last updated
Jul 4, 2025

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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