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Serological and Urinary Biomarkers in Latin American Patients With Systemic Lupus Erythematosus: GLADEL 2.0 Cohort

Serological and Urinary Biomarkers in Latin American Patients With Systemic Lupus Erythematosus: GLADEL 2.0 Cohort

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04534647
Enrollment
100
Registered
2020-09-01
Start date
2019-06-01
Completion date
2025-06-01
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis

Brief summary

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.

Interventions

DIAGNOSTIC_TESTdifferent serum and urine biomarkers

urine exosomes and serum biomarkers

Sponsors

Janssen Research & Development, LLC
CollaboratorINDUSTRY
Liga Panamericana de Asociaciones de Reumatologia (PANLAR)
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frame
Correlation between urinary biomarkers and NLBaseline to 60 months

Secondary

MeasureTime frame
Description of clinical features of patientsbaseline
Description of immunological characteristics of patients with NLBaseline to 60 months

Countries

Argentina

Contacts

Primary ContactAntonela Vannucci, SC
antonela.vannucci@gmail.com+543414261402
Backup ContactRosana Quintana, DM
rosanaquintana@gmail.com+5493415851333

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026