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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06428539
Other study ID # T cells in lupus LN
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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