T Regulatory Cells IN LUPUS NEPHRITIS

Lupus Nephritis Clinical Trial

Official title:

T Regulatory Cells in Lupus Nephritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06428539
• Other study ID #: T cells in lupus LN
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: Mohamed AH Hussein
• Phone: +966554599271
• Email: mohammedaggag30[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• To study the role FoxP3-positive T regulatory cells in the pathogenesis of Lupus Nephritis, and determine the factors associated with levels of T regs .

• To compare the functional capacity of T regs in LN and in normal individuals.

Description:

Lupus Nephritis (LN) encompasses a group of glomerulonephrites, that occur in association with systemic lupus erythematosus (SLE). The mainstream theory that it is an immune disease resulting from loss of immune tolerance against body cells. The regulatory T cells (T regs ) are a subpopulation of immune cells that maintain tolerance to self-antigens and suppress autoimmune diseases. The main marker of Tregs is FoxP3 (forkhead box protein 3) positivity. Moreover, It has been suggested that functional capacity of Tregs is also compromised in autoimmune diseases. Studying the role of T regs in LN is a promising field that can help tailor current immune therapy and develop new treatment strategies.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 65
• Est. completion date: August 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

adults both genders clinical diagnosis of lupus nephritis

Exclusion Criteria:

patients diagnosed with other renal pathologies, e.g. diabetic kidney disease

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Diagnostic Test:
• T-reg cells
laboratory test

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

Doglio M, Alexander T, Del Papa N, Snowden JA, Greco R; Autoimmune Diseases Working Party (ADWP) of the European Society for Blood and Marrow Transplantation (EBMT). New insights in systemic lupus erythematosus: From regulatory T cells to CAR-T-cell strat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FoxP3 between groups	mean difference of FoxP3 between groups.	baseline
Primary	Association of FoxP3 and activity index	correlation between level of FoxP3 and activity index in the group with active LN.	baseline
Primary	Tregs in normal and lupus participants	mean difference of suppression capacity of Tregs between normal participants and patients with active LN.	baseline