HLA AntibodiesLEDHLANCT06921239
HLA Antibodies in Systemic Lupus Erythematosus
An observational study of HLA Antibodies and Systemic Lupus Erythematosus, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Patients suffering from autoimmune diseases show false-positive results when anti-HLA antibodies are identified. This false positivity makes it difficult to obtain an organ transplant based on immunological compatibility (absence of anti-HLA antibodies directed against graft antigens). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HLA Antibodies, Systemic Lupus Erythematosus
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2025to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients Adults - Followed in the internal medicine department of Amiens University Hospital - With systemic lupus erythematosus - Without HLA immunization risk factors (no history of pregnancy, transfusions or transplants) - With sera stored in the biobank
Who may be able to join
- Patients Adults
- Followed in the internal medicine department of Amiens University Hospital - With systemic lupus erythematosus
- Without HLA immunization risk factors (no history of pregnancy, transfusions or transplants)
- With sera stored in the biobank
Who cannot join
- minor Patients
- Opposing the re-use of their personal data for research purposes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Amiens
Amiens, 80054
Nicolas Guillaume, Pr, 33+322087046, guillaume.nicolas@chu-amiens.fr
About this study
Patients suffering from autoimmune diseases show false-positive results when anti-HLA antibodies are identified. This false positivity makes it difficult to obtain an organ transplant based on immunological compatibility (absence of anti-HLA antibodies directed against graft antigens). The objectives of this project are to study the prevalence of these false positivities in a population of lupus patients, and to evaluate biological tests that can negate these false positivities.
- Conditions
- HLA Antibodies, Systemic Lupus Erythematosus
- Keywords
- HLA antibodies, systemic lupus erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of unexplained antibody positivity
prevalence of unexplained antibody positivity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start10 Feb 2025
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HLA AntibodiesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921239
- Sponsor's protocol ID
- PI2025_843_0043
- Acronym
- LEDHLA
- Status last verified
- Jan 2026
- First submitted
- 28 Mar 2025
- Last updated
- 16 Jan 2026
- 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HLA Antibodies in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06921239
- Acronym / sponsor ID
- LEDHLA / PI2025_843_0043
- Conditions
- HLA Antibodies, Systemic Lupus Erythematosus
- Keywords
- HLA antibodies, systemic lupus erythematosus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 10 Apr 2025 (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.
Patients suffering from autoimmune diseases show false-positive results when anti-HLA antibodies are identified. This false positivity makes it difficult to obtain an organ transplant based on immunological compatibility (absence of anti-HLA antibodies directed against graft antigens). The objectives of this project are to study the prevalence of these false positivities in a population of lupus patients, and to evaluate biological tests that can negate these false positivities.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Adults - Followed in the internal medicine department of Amiens University Hospital - With systemic lupus erythematosus - Without HLA immunization risk factors (no history of pregnancy, transfusions or transplants) - With sera stored in the biobank
Key inclusion criteria (4 listed)
- Patients Adults
- Followed in the internal medicine department of Amiens University Hospital - With systemic lupus erythematosus
- Without HLA immunization risk factors (no history of pregnancy, transfusions or transplants)
- With sera stored in the biobank
Key exclusion criteria (2 listed)
- minor Patients
- Opposing the re-use of their personal data for research purposes
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
prevalence of unexplained antibody positivity
Time frame: 6 months
prevalence of unexplained antibody positivity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HLA Antibodies and Systemic Lupus Erythematosus, run by Centre Hospitalier Universitaire, Amiens at 1 site 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas GUILLAUME, Pr (33+322087046, guillaume.nicolas@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of unexplained antibody positivity (time frame: 6 months). 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 16 Jan 2026.