NCT06921239

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
12mo left

Started Feb 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Feb 2025May 2027

Study Start

First participant enrolled

February 10, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

March 28, 2025

Last Update Submit

January 15, 2026

Conditions

HLA AntibodiesSystemic Lupus Erythematosus

Keywords

HLA antibodiessystemic lupus erythematosus

Outcome Measures

Primary Outcomes (1)

  • prevalence of unexplained antibody positivity

    prevalence of unexplained antibody positivity

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • minor Patients
  • Opposing the re-use of their personal data for research purposes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Nicolas GUILLAUME, Pr

CONTACT

33+322087046guillaume.nicolas@chu-amiens.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 10, 2025

Study Start

February 10, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)