Systemic Lupus Erythematosus
Conditions
Keywords
Systemic Lupus Erythematosus, Lupus Nephritis, Flow Cytometry, CD4-Positive T-Lymphocytes, Biomarker, Urine Specimen Collection
Brief summary
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.
Interventions
None listed
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal flares within the next 6 months | 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. |
Secondary
| Measure | 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 |
Countries
Germany
Contacts
Primary ContactPhilipp Enghard, PD Dr. med.
Backup ContactJohanna S Kotzbauer
Outcome results
None listed