Prediction of Lupus Renal Flares Study

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05362812
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 9.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prediction of Lupus Renal Flares Study
• Actual Study Start Date: Feb 28, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients with systemic lupus erythematosus 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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

2. 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]

3. To evaluate whether increased surface expression of CD38 on peripheral blood memory T cells is associated with the presence of renal involvement. [6 months]

4. 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]

5. Investigate whether Belimumab treatment has a beneficial impact on biomarkers associated with renal flares and loss of renal function. [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nephrology and Intensive Care, Charite University Hospital	Berlin		Germany	10117

Sponsors and Collaborators

• Charite University, Berlin, Germany

Investigators

• Principal Investigator: Philipp Enghard, MD, Department of Nephrology and Intensive Care, Charite University Hospital
• Principal Investigator: Tobias Alexander, MD, Department of Rheumatology and Clinical Immunology, Charite University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Philipp Enghard, PD Dr. med, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT05362812
• Other Study ID Numbers: PreLuFlare
• First Posted: May 5, 2022
• Last Update Posted: May 10, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Philipp Enghard, PD Dr. med, Charite University, Berlin, Germany: Systemic Lupus Erythematosus; Lupus Nephritis; Flow Cytometry; CD4-Positive T-Lymphocytes; Biomarker; Urine Specimen Collection
• Additional relevant MeSH terms: Lupus Erythematosus, Systemic

Study Results

No Results Posted as of May 10, 2022