Lupus NephritisNCT04534647
Serological and Urinary Biomarkers in Latin American Patients With Systemic Lupus Erythematosus: GLADEL 2.0 Cohort
An observational study of Lupus Nephritis, run by Liga Panamericana de Asociaciones de Reumatologia (PANLAR) at 1 site in Argentina.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- different serum and urine biomarkers
- How many people
- 100 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jun 2019to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Bernardo Pons-Estel
Rosario, 2000
Antonella Vannucci, SC, +543414261402, antonela.vannucci@gmail.com
Rosana Quintana, MD, +5493415851333, rosanaquintana@gmail.com
About this study
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.
- Conditions
- Lupus Nephritis
- Being tested
- different serum and urine biomarkers
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different serum and urine biomarkersDiagnostic test
Also called Transcriptome studies
urine exosomes and serum biomarkers
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between urinary biomarkers and NL
Measured: Baseline to 60 months
Secondary outcomes (2)
Description of clinical features of patients
Measured: baseline
Description of immunological characteristics of patients with NL
Measured: Baseline to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start1 Jun 2019
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liga Panamericana de Asociaciones de Reumatologia (PANLAR)
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Principal investigator, Bernardo A Pons-Estel, Liga Panamericana de Asociaciones de Reumatologia (PANLAR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534647
- Sponsor's protocol ID
- GLADEL LUPUS
- Status last verified
- Apr 2021
- First submitted
- 24 Aug 2020
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42009373
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serological and Urinary Biomarkers in Latin American Patients With Systemic Lupus Erythematosus: GLADEL 2.0 Cohort
- ClinicalTrials.gov ID
- NCT04534647
- Acronym / sponsor ID
- GLADEL LUPUS
- Conditions
- Lupus Nephritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Liga Panamericana de Asociaciones de Reumatologia (PANLAR)University, hospital or other
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| different serum and urine biomarkersAlso: Transcriptome studiesurine exosomes and serum biomarkers | Diagnostic test | – |
Primary outcome
Correlation between urinary biomarkers and NL
Time frame: Baseline to 60 months
2 secondary outcomes
Description of clinical features of patients
Time frame: baseline
Description of immunological characteristics of patients with NL
Time frame: Baseline to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Derived from this study: PubMed 42009373Pons-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Nephritis, run by Liga Panamericana de Asociaciones de Reumatologia (PANLAR) at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonela Vannucci, SC (+543414261402, antonela.vannucci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between urinary biomarkers and NL (time frame: Baseline to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04534647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.