Lupus NephritisJD001NCT05443516
Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus
An observational study of Lupus Nephritis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The aim of this research project is to better understand the origin and clinical significance of two lupus-specific "genetic signatures" (IFN signature and plasma cell signature) in patient subgroups with well-defined clinical characteristics. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lupus Nephritis
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Jun 2014to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- Adult, Older adult
Study population: Incident or Flare biopsy-proven proliferative or membranous LN diagnosis
Who may be able to join
- Fulfilment of the EULAR/ACR classification criteria of SLE.
- 18 years of age or above.
- Incident or Flare biopsy-proven proliferative or membranous LN
Who cannot join
- Antiphospholipid syndrome nephropathy (APSN).
- Pregnancy at baseline (pregnancy during follow-up will not lead to exclusion).
- Anticipated non-adherence to therapy.
- Medical conditions interfering with outcome evaluations.
- Inability to read and/or sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Farah Tamirou, Dr, +32 02 764 53 87, farah.tamirou@uclouvain.be
About this study
Official title: Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus. Recherche de Biomarqueurs de l'activité de la Maladie Chez Des Patients Atteints de Lupus érythémateux disséminé.
The aim of this research project is to better understand the origin and clinical significance of two lupus-specific "genetic signatures" (IFN signature and plasma cell signature) in patient subgroups with well-defined clinical characteristics. Our aim is to correlate these genetic signatures with cell activation profiles and the production of specific cytokines in different populations from whole blood and in short-term cultures of these circulating cells.
Read the detailed description
The aim of the experiment is, on the one hand, to identify and study the different cell populations from whole blood by flow cytometry and, on the other hand, to assay different cytokines in blood and urine samples from diseased (SLE) and control subjects (with non-inflammatory rheumatic diseases) in order to highlight and correlate the presence of biomarkers to disease activity or to a clinical manifestation of the disease.
In vitro studies will also be carried out on short-term cultures of PBMCs (Peripheral Blood Mononuclear Cells).
- Conditions
- Lupus Nephritis
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Systemic Lupus Erythematosus - Lupus Nephritis Cohort | Systemic Lupus Erythematosus - Lupus Nephritis Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker analysis of lupus nephritis activity - whole blood cell populations
whole blood cell populations - flow cytometry assay
Measured: baseline
Biomarker analysis of lupus nephritis activity - blood cytokines
blood cytokines - flow cytometry assay
Measured: baseline
Biomarker analysis of lupus nephritis activity - urine cytokines
urine cytokines - flow cytometry assay
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start16 Jun 2014
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Houssiau, Pr, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443516
- Sponsor's protocol ID
- 2014/07AVR/170
- Acronym
- JD001
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus. Recherche de Biomarqueurs de l'activité de la Maladie Chez Des Patients Atteints de Lupus érythémateux disséminé.
- ClinicalTrials.gov ID
- NCT05443516
- Acronym / sponsor ID
- JD001 / 2014/07AVR/170
- Conditions
- Lupus Nephritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 16 Jun 2014 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 5 Jul 2022 (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.
The aim of this research project is to better understand the origin and clinical significance of two lupus-specific "genetic signatures" (IFN signature and plasma cell signature) in patient subgroups with well-defined clinical characteristics. Our aim is to correlate these genetic signatures with cell activation profiles and the production of specific cytokines in different populations from whole blood and in short-term cultures of these circulating cells.
Detailed description
The aim of the experiment is, on the one hand, to identify and study the different cell populations from whole blood by flow cytometry and, on the other hand, to assay different cytokines in blood and urine samples from diseased (SLE) and control subjects (with non-inflammatory rheumatic diseases) in order to highlight and correlate the presence of biomarkers to disease activity or to a clinical manifestation of the disease.
In vitro studies will also be carried out on short-term cultures of PBMCs (Peripheral Blood Mononuclear Cells).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systemic Lupus Erythematosus - Lupus Nephritis Cohort | – | –Systemic Lupus Erythematosus - Lupus Nephritis Cohort |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Incident or Flare biopsy-proven proliferative or membranous LN diagnosis
Key inclusion criteria (3 listed)
- Fulfilment of the EULAR/ACR classification criteria of SLE.
- 18 years of age or above.
- Incident or Flare biopsy-proven proliferative or membranous LN
Key exclusion criteria (5 listed)
- Antiphospholipid syndrome nephropathy (APSN).
- Pregnancy at baseline (pregnancy during follow-up will not lead to exclusion).
- Anticipated non-adherence to therapy.
- Medical conditions interfering with outcome evaluations.
- Inability to read and/or sign the informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biomarker analysis of lupus nephritis activity - whole blood cell populations
Time frame: baseline
whole blood cell populations - flow cytometry assay
Biomarker analysis of lupus nephritis activity - blood cytokines
Time frame: baseline
blood cytokines - flow cytometry assay
Biomarker analysis of lupus nephritis activity - urine cytokines
Time frame: baseline
urine cytokines - flow cytometry assay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
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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.
Frédéric Houssiau, Pr principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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 Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 5 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: looking for participants now, as of the sponsor's last update on 5 Jul 2022. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédéric Houssiau, Pr (+32 02 764 53 90, frederic.houssiau@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker analysis of lupus nephritis activity - whole blood cell populations (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2022.