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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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Lupus nephritis (LN) is one of the main manifestationsin SLE patients, having an important impact on morbidity and mortality. Renal biopsy is the "gold standard" for the diagnosis of LN, however, it is an invasive technique, not free of complications,which is not recommended to be performed serially as a follow-up tool for patients with LN. Searching for biomarkers in SLE has been the subject of interesting research, although results have not always been relevant. Multiple biomarkers have been studied in different locations (soluble markers in blood, urine and biological fluids),of different nature(autoantibodies, genetic markers of "kidney damage") looking atdiagnostic and/orprognostic features. In recent years, several biomarkers have been developed that seek to find an association with pathological patterns, with pathogenic mechanisms and with a non-invasive diagnosis of different glomerulopathies, allowing the identification of prognostic subgroups in each type of kidney disease, while predicting response to treatment and/or recurrence. To date, double-stranded anti-DNA antibodies (anti-dsDNA) and serum complement are the only non-invasive routine biomarkers for monitoring renal activity in patients with LN. However, these markers are only the reflection of the immune activity of the disease and they are not markers of renal damage or poor prognosis. For all the above, the purpose of this study is, in a case-control study, to evaluate simultaneously serum (ANA, anti-dsDNA, anti-C1q, anti-cardiolipin IgG and IgM, anti-ß2GPI IgG and IgM, anti-phosphatidylserine/prothrombin antibodies, and anti-DFS70 antibodies) and urinary biomarkers, and the presence of anti-DFS70 antibodies, in a multiethnic cohort of patients with SLE such as the cohort of GLADEL, and assess its possible correlation with various socio-demographic, clinical and serological manifestations of the disease.
In subgroup of patients, transcriptome studies will be performed using RNA from blood and tissue to identify possible transcriptional signatures.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| different serum and urine biomarkers | Diagnostic Test | urine exosomes and serum biomarkers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between urinary biomarkers and NL | Baseline to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Description of clinical features of patients | baseline | |
| Description of immunological characteristics of patients with NL | Baseline to 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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Each center will include 25 patients with SLE divided into four groups, each with their corresponding healthy control (ratio 1:1).
Group 1.Patients with SLE, without renal involvement (never), of any time of disease duration. Total: 10 patients.
Group 2.Patients with SLE, with prevalent renal involvement (at any time of evolution), currently inactive (*): Total: 5 patients.
Group 3.Patients with SLE,with prevalent renal involvement (atany time of evolution), currently active (*). Total: 5 patients.
Group 4.Patients with SLE,with incident renal involvementof recent onset (maximum 3 months), without immunosuppressive treatment and with renal biopsy (mandatory criterion). Total: 5 patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonela Vannucci, SC | Contact | +543414261402 | antonela.vannucci@gmail.com | |
| Rosana Quintana, DM | Contact | +5493415851333 | rosanaquintana@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bernardo Pons-Estel | Recruiting | Rosario | 2000 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42009373 | Derived | Pons-Estel GJ, Nieto RE, Quintana R, Serrano Morales R, Borba EF, Hernandez L, Harvey GB, Roberts K, Fernandez-Avila DC, Scolnik M, Funes Soaje C, Otaduy C, Saurit V, Arturi V, Berbotto GA, Gonzalez Lucero L, Kerzberg E, Gomez GN, Pisoni CN, Juarez V, Martinez Serventi J, Isnardi CA, Parente Costa Seguro L, Montadon ACOS, Monticielo OA, Mariz HA, Machado Ribeiro F, Dos Reis-Neto ET, Guerra I, Massardo L, Aroca Martinez G, Iglesias Gamarra A, Canas CA, Quintana Lopez G, Toro Gutierrez CE, Moreno Alvarez MJ, Saavedra MA, Portela Hernandez M, Perez Cristobal M, Fragoso Loyo H, Juarez-Vicuna Y, Gonzalez-Bello YC, Abud-Mendoza C, Esquivel-Valerio JA, Langjahr P, Paats A, Mora Trujillo C, Ugarte-Gil MF, Calvo-Quiroz A, Munoz Louis R, Rebella M, Danza A, Sbarigia U, Zazzetti F, Orillion A, Gomez Puerta JA, Alarcon GS, Pons-Estel BA. Baseline characteristics of patients with SLE with and without lupus nephritis from the Latin American multiethnic GLADEL 2.0 cohort. Lupus Sci Med. 2026 Apr 20;13(1):e001878. doi: 10.1136/lupus-2025-001878. |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |