Clinical trial NCT05362812: Prediction of Lupus Renal Flares Study
Official title: Prediction of Lupus Renal Flares Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
Lupus Nephritis
Flow Cytometry
CD4-Positive T-Lymphocytes
Biomarker
Urine Specimen Collection
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with systemic lupus erythematosus from the outpatient clinic of the Department of Rheumatology and Clinical Immunology, University Hospital Charité, Berlin

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.


Eligibility criteria: 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

Primary outcomes:
measure: Renal flares within the next 6 months
timeFrame: 6 months
Secondary outcomes:
measure: 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).
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: To evaluate whether increased surface expression of CD38 on peripheral blood memory T cells is associated with the presence of renal involvement.
timeFrame: 6 months
measure: 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)
timeFrame: 6 months
measure: Investigate whether Belimumab treatment has a beneficial impact on biomarkers associated with renal flares and loss of renal function.
timeFrame: 6 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Nephrology and Intensive Care, Charite University Hospital
Study officials:
affiliation: Department of Nephrology and Intensive Care, Charite University Hospital
name: Philipp Enghard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Rheumatology and Clinical Immunology, Charite University Hospital
name: Tobias Alexander, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Enghard P, Rieder C, Kopetschke K, Klocke JR, Undeutsch R, Biesen R, Dragun D, Gollasch M, Schneider U, Aupperle K, Humrich JY, Hiepe F, Backhaus M, Radbruch AH, Burmester GR, Riemekasten G. Urinary CD4 T cells identify SLE patients with proliferative lupus nephritis and can be used to monitor treatment response. Ann Rheum Dis. 2014 Jan;73(1):277-83. doi: 10.1136/annrheumdis-2012-202784. Epub 2013 Mar 8.
citation: Rose T, Grutzkau A, Klotsche J, Enghard P, Flechsig A, Keller J, Riemekasten G, Radbruch A, Burmester GR, Dorner T, Hiepe F, Biesen R. Are interferon-related biomarkers advantageous for monitoring disease activity in systemic lupus erythematosus? A longitudinal benchmark study. Rheumatology (Oxford). 2017 Sep 1;56(9):1618-1626. doi: 10.1093/rheumatology/kex220.
citation: Burns M, Ostendorf L, Biesen R, Grutzkau A, Hiepe F, Mei HE, Alexander T. Dysregulated CD38 Expression on Peripheral Blood Immune Cell Subsets in SLE. Int J Mol Sci. 2021 Feb 28;22(5):2424. doi: 10.3390/ijms22052424.