Prediction of Lupus Renal Flares Study

Systemic Lupus Erythematosus Clinical Trial

Official title:

Prediction of Lupus Renal Flares Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05362812
• Other study ID #: PreLuFlare
• Status: Recruiting
• Start date: February 28, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: May 2022
• Source: Charite University, Berlin, Germany
• Contact: Philipp Enghard, PD Dr. med.
• Phone: 030 450 614016
• Email: philipp.enghard[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Locations

Country	Name	City	State
Germany	Department of Nephrology and Intensive Care, Charite University Hospital	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Burns M, Ostendorf L, Biesen R, Grützkau 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). pii: 2424. doi: 10.3390/ijms22052424. — View 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. — View Citation

Rose T, Grützkau A, Klotsche J, Enghard P, Flechsig A, Keller J, Riemekasten G, Radbruch A, Burmester GR, Dörner 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	To evaluate whether increased surface expression of CD38 on peripheral blood memory T cells is associated with the presence of renal involvement.		6 months
Secondary	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
Secondary	Investigate whether Belimumab treatment has a beneficial impact on biomarkers associated with renal flares and loss of renal function.		6 months