Prediction of Lupus Renal Flares Study

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT05362812
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-28
• Status Verified: 2022-05
• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-05-02
• Last Update Submitted: 2022-05-04
• Study First Posted: 2022-05-05
• Last Update Posted: 2022-05-10
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 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
Investigate whether Belimumab treatment has a beneficial impact on biomarkers associated with renal flares and loss of renal function.	6 months

Trial Locations

Locations (1)

Department of Nephrology and Intensive Care, Charite University Hospital; 🇩🇪 Berlin, Germany