Understanding genetic signatures in lupus nephritis patients
Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus. Recherche de Biomarqueurs de l'activité de la Maladie Chez Des Patients Atteints de Lupus érythémateux disséminé.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain · NCT05443516
This study is trying to understand how certain genetic markers in people with lupus nephritis can help explain their disease and how their immune system is responding.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain (other) |
| Locations | 1 site (Brussels) |
| Trial ID | NCT05443516 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the origins and clinical significance of two specific genetic signatures associated with systemic lupus erythematosus (SLE) in patients with lupus nephritis. Researchers will analyze blood samples to identify different cell populations and measure cytokine levels, correlating these findings with disease activity and clinical manifestations. The study will utilize flow cytometry and in vitro assays on peripheral blood mononuclear cells to gather comprehensive data on the immune response in affected individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with systemic lupus erythematosus and have biopsy-proven lupus nephritis.
Not a fit: Patients with antiphospholipid syndrome nephropathy or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved biomarkers for monitoring disease activity in lupus nephritis patients.
How similar studies have performed: While there have been studies exploring genetic signatures in lupus, this specific approach focusing on the correlation with disease activity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fulfilment of the EULAR/ACR classification criteria of SLE. * 18 years of age or above. * Incident or Flare biopsy-proven proliferative or membranous LN Exclusion Criteria: * Antiphospholipid syndrome nephropathy (APSN). * Pregnancy at baseline (pregnancy during follow-up will not lead to exclusion). * Anticipated non-adherence to therapy. * Medical conditions interfering with outcome evaluations. * Inability to read and/or sign the informed consent form.
Where this trial is running
Brussels
- Cliniques universitaires Saint-Luc — Brussels, Belgium (RECRUITING)
Study contacts
- Principal investigator: Frédéric Houssiau, Pr — Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study coordinator: Frédéric Houssiau, Pr
- Email: frederic.houssiau@uclouvain.be
- Phone: +32 02 764 53 90
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lupus Nephritis