Prediction of Lupus Renal Flares Study

Charité University Medicine Berlin

Status: Unknown

Conditions: Systemic Lupus Erythematosus

Study type: Observational

Funder types: Other

Identifiers

NCT05362812

PreLuFlare

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 1 patient group

Patients with systemic lupus erythematosus

Description:

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