Prediction of Lupus Renal Flares Study

Study Overview
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Brief Summary
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In patients with systemic lupus erythematosus, urinary CD4+ T cells may have the potential to predict subsequent renal flares in the next 6 months. Patients with systemic lupus erythematosus from our outpatient clinic will be included in this cross-sectional, prospective biomarker study regardless of disease activity, clinical phenotype, and disease duration or baseline therapy. Urinary T cells will be analyzed by flow cytometry. 6 months after sample collection a clinical follow-up will be conducted to assess the occurrence of either recurrent or de novo renal flares.

Official Title
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Prediction of Lupus Renal Flares Study

Conditions
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Systemic Lupus Erythematosus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent Diagnosis of SLE according to the 2019 EULAR/ACR classification criteria Stable immunosuppressive or biologic background therapy within the last 6 months prior to inclusion Exclusion Criteria: Age < 18 Inability to consent Urinary tract infection (defined by detection of nitrite or positive urine culture) Patients on chronic dialysis Concomitant other autoimmune disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with systemic lupus erythematosus<br>Diagnostic Test: Flow cytometry analysis of urine samples. Urine samples will be conserved and frozen upon arrival. All samples will be stained according to T cell and B cell panel with fluorochromes. T cell panel: CD3, CD4, CD8, CCR7, CD45RO, CD38, CD279; B cell panel: CD19, CD20, CD27, CD38, CD21, IgD, CXCR5 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal flares within the next 6 months | To evaluate whether the number of urinary CD4+ T cells has the potential to predict subsequent renal flares in the next 6 months. Renal flares will be defined as an increase of proteinuria by > 0.5 g/g creatinine or an increase in creatinine by 30% without other likely explanation or a novel kidney biopsy demonstrating lupus nephritis. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate whether the phenotype of urinary T cell subsets can predict renal involvement or subsequent renal flares in preexisting LN (CD4+ and CD8+ T cells subsets). |  | 6 months | 
| To investigate whether the number and phenotype of urinary B- and plasma cell subsets can predict renal involvement or subsequent renal flares in preexisting LN |  | 6 months | 
| To evaluate whether increased surface expression of CD38 on peripheral blood memory T cells is associated with the presence of renal involvement. |  | 6 months | 
| To assess whether urinary or peripheral blood T- and B cell subsets or IFN-I activity can predict the incidence of mild/moderate or severe flares of SLE according to the SELENA-SLEDAI Flare Index (SFI) |  | 6 months | 
| Investigate whether Belimumab treatment has a beneficial impact on biomarkers associated with renal flares and loss of renal function. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic Lupus Erythematosus, Lupus Nephritis, Flow Cytometry, CD4-Positive T-Lymphocytes, Biomarker, Urine Specimen Collection