Lung TransplantationAFFIHLA-PNCT03474536
Quantitative Parameters of HLA-DQ Antibodies in Lung Transplantation
An observational study of Lung Transplantation and Antibody Mediated Rejection, run by University Hospital, Bordeaux at 5 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation, Antibody Mediated Rejection, Chronic Lung Allograft Dysfunction
- How many people
- 88 participants
- Where
- 5 sitesFrance
- Study dates
- 14 Mar 2018to 8 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 122 patients with lung transplantation at University Hospital of Bordeaux and 4 departments of lung transplantation from Paris (Marie Lannelongue, Foch, Bichat and HEGP hospitals
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Bordeaux
Bordeaux
Hôpital Marie Lannelongue
Le Plessis-Robinson, 92350
Hôpital Européen Georges Pompidou
Paris, 75015
AP-HP Hôpital Bichat
Paris, 75877
Hôpital Foch
Suresnes, 92150
About this study
Official title: Clinical Impact of Concentration and Affinity of HLA-DQ Antibodies in Lung Transplantation - AFFIHLA-P
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 .
Read the 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.
- Keywords
- Lung transplantation, HLA antibodies, concentration, affinity, surface plasmon resonance
What is being measured
The primary outcome is the main question the study is designed to answer.
CLAD development
CLAD development within the 2 years following DSA apparition
Measured: 2 years
Secondary outcomes (3)
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
Measured: 6 months, 1 year, 2 years, 5 years
CLAD development
CLAD development 6 months following DSA apparition
Measured: 6 months
CLAD development
CLAD development 1 year following DSA apparition
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start14 Mar 2018
- Primary completion8 Apr 2025
- Study completion8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474536
- Sponsor's protocol ID
- CHUBX 2017/35
- Acronym
- AFFIHLA-P
- Status last verified
- Jul 2025
- First submitted
- 5 Mar 2018
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Concentration and Affinity of HLA-DQ Antibodies in Lung Transplantation - AFFIHLA-P
- ClinicalTrials.gov ID
- NCT03474536
- Acronym / sponsor ID
- AFFIHLA-P / CHUBX 2017/35
- Keywords
- Lung transplantation, HLA antibodies, concentration, affinity, surface plasmon resonance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 122 patients with lung transplantation at University Hospital of Bordeaux and 4 departments of lung transplantation from Paris (Marie Lannelongue, Foch, Bichat and HEGP hospitals
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CLAD development
Time frame: 2 years
CLAD development within the 2 years following DSA apparition
3 secondary outcomes
raft loss up to 5 years following DSA apparition
Time frame: 6 months, 1 year, 2 years, 5 years
CLAD development
Time frame: 6 months
CLAD development
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplantation and Antibody Mediated Rejection, run by University Hospital, Bordeaux at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CLAD development (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.