Identifying biomarkers in Latin American patients with lupus nephritis
Serological and Urinary Biomarkers in Latin American Patients With Systemic Lupus Erythematosus: GLADEL 2.0 Cohort
Liga Panamericana de Asociaciones de Reumatologia (PANLAR) · NCT04534647
This study is trying to find new blood and urine tests that can help diagnose lupus nephritis in Latin American patients without needing a kidney biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Liga Panamericana de Asociaciones de Reumatologia (PANLAR) (other) |
| Locations | 1 site (Rosario) |
| Trial ID | NCT04534647 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on identifying serological and urinary biomarkers in patients with systemic lupus erythematosus (SLE) and lupus nephritis. It aims to explore non-invasive diagnostic methods that could replace the need for invasive renal biopsies, which are currently the gold standard for diagnosing lupus nephritis. By analyzing various biomarkers, the study seeks to establish associations with pathological patterns and prognostic features in this patient population. The research will include consecutive patients diagnosed with SLE who meet specific classification criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of systemic lupus erythematosus.
Not a fit: Patients with other systemic autoimmune diseases, urinary infections, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of non-invasive diagnostic tools for lupus nephritis, improving patient care and outcomes.
How similar studies have performed: Previous studies have explored biomarkers in lupus nephritis, but this approach may provide novel insights specific to the Latin American population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consecutive patients with a diagnosis of SLE will be included. Patients should meet at least one ofthe classification criteria: ACR 1982/1997 (1) and/or SLICC 2012 (2) to determine the efficacy of calcineurin inhibitor-containing treatment regimens in LN cohorts by ethnic groups. * Age ≥18 years old. * Patients and controls that volunteer toparticipate and sign the informed consent Exclusion Criteria: * Patients with other systemic autoimmune diseases or overlap syndrome (rheumatoid arthritis, systemic sclerosis, dermatomyositis, systemic vasculitis and others). * Patients who have urinary infection, pregnancy or have a history of hepatitis B, C or HIV virus infection. * Those patients presenting with antiphospholipid syndrome (APS) associated with lupus will not be excluded from the study.
Where this trial is running
Rosario
- Bernardo Pons-Estel — Rosario, Argentina (RECRUITING)
Study contacts
- Study coordinator: Antonela Vannucci, SC
- Email: antonela.vannucci@gmail.com
- Phone: +543414261402
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