T Regulatory Cells IN LUPUS NEPHRITIS

May 25, 2024 updated by: Mohamed AbdEllah Ahmed Hussein, Assiut University

T Regulatory Cells in Lupus Nephritis

  • 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

Inclusion Criteria:

adults both genders clinical diagnosis of lupus nephritis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with active lupus nephritis
patients with active lupus nephritis as active urinary sediment, or rising renal chemistry
Diagnostic test: T-reg cells
laboratory test
Other Names:
  • t regulatory cells
patients with lupus nephritis in remission
Patients who were previously active, but now in remission
Diagnostic test: T-reg cells
laboratory test
Other Names:
  • t regulatory cells
normal individuals
normal healthy participants
Diagnostic test: T-reg cells
laboratory test
Other Names:
  • t regulatory cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FoxP3 between groups
Time Frame: baseline
mean difference of FoxP3 between groups.
baseline
Association of FoxP3 and activity index
Time Frame: baseline
correlation between level of FoxP3 and activity index in the group with active LN.
baseline
Tregs in normal and lupus participants
Time Frame: baseline
mean difference of suppression capacity of Tregs between normal participants and patients with active LN.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
factors affecting FoxP3
Time Frame: baseline
- determinants of FoxP3, i.e. clinical and lab factors that affect levels of Tregs.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

May 21, 2024

First Submitted That Met QC Criteria

May 21, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 25, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T cells in lupus LN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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