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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04534647
Recruitment Status : Recruiting
First Posted : September 1, 2020
Last Update Posted : April 26, 2021
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bernardo A Pons-Estel, Liga Panamericana de Asociaciones de Reumatologia (PANLAR)

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.

Condition or disease Intervention/treatment
Lupus Nephritis Diagnostic Test: different serum and urine biomarkers

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Serological and Urinary Biomarkers in Latin American Patients With Systemic Lupus Erythematosus: GLADEL 2.0 Cohort
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2025

Intervention Details:
  • Diagnostic Test: different serum and urine biomarkers
    urine exosomes and serum biomarkers
    Other Name: Transcriptome studies

Primary Outcome Measures :
  1. Correlation between urinary biomarkers and NL [ Time Frame: Baseline to 60 months ]

Secondary Outcome Measures :
  1. Description of clinical features of patients [ Time Frame: baseline ]
  2. Description of immunological characteristics of patients with NL [ Time Frame: Baseline to 60 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04534647

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Contact: Antonela Vannucci, SC +543414261402
Contact: Rosana Quintana, DM +5493415851333

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Bernardo Pons-Estel Recruiting
Rosario, Argentina, 2000
Contact: Antonella Vannucci, SC    +543414261402   
Contact: Rosana Quintana, MD    +5493415851333   
Sponsors and Collaborators
Liga Panamericana de Asociaciones de Reumatologia (PANLAR)
Janssen Research & Development, LLC
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Responsible Party: Bernardo A Pons-Estel, Clinical Professor, Liga Panamericana de Asociaciones de Reumatologia (PANLAR) Identifier: NCT04534647    
Other Study ID Numbers: GLADEL LUPUS
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Nephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases