T Regulatory Cells IN LUPUS NEPHRITIS

NCT06428539 | Not Yet Recruiting

• 1 other identifier: T cells in lupus LN
• Study Type: observational
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (3)

• FoxP3 between groups

  mean difference of FoxP3 between groups.

  baseline

• Association of FoxP3 and activity index

  correlation between level of FoxP3 and activity index in the group with active LN.

  baseline

• Tregs in normal and lupus participants

  mean difference of suppression capacity of Tregs between normal participants and patients with active LN.

  baseline

Study Arms (3)

patients with active lupus nephritis

patients with active lupus nephritis as active urinary sediment, or rising renal chemistry

Diagnostic Test: T-reg cells

patients with lupus nephritis in remission

Patients who were previously active, but now in remission

Diagnostic Test: T-reg cells

normal individuals

normal healthy participants

Diagnostic Test: T-reg cells

Interventions

T-reg cells DIAGNOSTIC_TEST

laboratory test

Also known as: t regulatory cells

normal individuals; patients with active lupus nephritis; patients with lupus nephritis in remission

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with lupus nephritis, both currently active or in remission, divided in Group 1: active lupus nephritis, Group 2: lupus nephritis in remission. Besides including normal Group 3: healthy volunteers

You may qualify if:

• adults both genders clinical diagnosis of lupus nephritis

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related 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 strategies. J Allergy Clin Immunol. 2022 Dec;150(6):1289-1301. doi: 10.1016/j.jaci.2022.08.003. Epub 2022 Sep 20.

  PMID: 36137815 RESULT

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Mohamed AH Hussein

CONTACT

+966554599271; mohammedaggag30@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 24, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share