## Protocol Section
### Identification Module
**NCT ID:** NCT06428539

**Brief Title:** T Regulatory Cells IN LUPUS NEPHRITIS

**Official Title:** T Regulatory Cells in Lupus Nephritis

#### Organization Study ID Info
**ID:** T cells in lupus LN
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2025-08-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-25

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assiut University

#### Responsible Party

**Investigator Affiliation:** Assiut University

**Investigator Full Name:** Mohamed AbdEllah Ahmed Hussein

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Lupus Nephritis

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 65

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Diagnostic Test: T-reg cells

**Label:** patients with active lupus nephritis

#### Arm Group 2

**Description:** Patients who were previously active, but now in remission

**Intervention Names:**

- Diagnostic Test: T-reg cells

**Label:** patients with lupus nephritis in remission

#### Arm Group 3

**Description:** normal healthy participants

**Intervention Names:**

- Diagnostic Test: T-reg cells

**Label:** normal individuals

### Interventions

#### Intervention 1

**Arm Group Labels:**

- normal individuals

- patients with active lupus nephritis

- patients with lupus nephritis in remission

**Description:** laboratory test

**Name:** T-reg cells

**Other Names:**

- t regulatory cells

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** mean difference of FoxP3 between groups.

**Measure:** FoxP3 between groups

**Time Frame:** baseline

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

**Measure:** Association of FoxP3 and activity index

**Time Frame:** baseline

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

**Measure:** Tregs in normal and lupus participants

**Time Frame:** baseline

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

adults both genders clinical diagnosis of lupus nephritis

Exclusion Criteria:

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

**Healthy Volunteers:** True

**Maximum Age:** 85 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mohammedaggag30@gmail.com

**Name:** Mohamed AH Hussein

**Phone:** +966554599271

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000005921

- Term: Glomerulonephritis

- ID: D000008180

- Term: Lupus Erythematosus, Systemic

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12338

- Name: Nephritis

- Relevance: HIGH

- As Found: Nephritis

- ID: M11178

- Name: Lupus Nephritis

- Relevance: HIGH

- As Found: Lupus Nephritis

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9031

- Name: Glomerulonephritis

- Relevance: LOW

- As Found: Unknown

- ID: M11177

- Name: Lupus Erythematosus, Systemic

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3523

- Name: Lupus Nephritis

- Relevance: HIGH

- As Found: Lupus Nephritis

- ID: T2525

- Name: Glomerulonephritis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009393

- Term: Nephritis

- ID: D000008181

- Term: Lupus Nephritis

### Misc Info Module

- Version Holder: 2024-05-31
