Lupus NephritisNCT06428539
T Regulatory Cells IN LUPUS NEPHRITIS
An observational study of Lupus Nephritis, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- T-reg cells
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- 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
Who may be able to join
- adults both genders clinical diagnosis of lupus nephritis
Who cannot join
- patients diagnosed with other renal pathologies, e.g. diabetic kidney disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Lupus Nephritis
- Being tested
- T-reg cells
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-reg cellsDiagnostic test
Also called t regulatory cells
laboratory test
| Study group | Role | What they receive |
|---|---|---|
| patients with active lupus nephritis | patients with active lupus nephritis as active urinary sediment, or rising renal chemistry Receives: Diagnostic Test: T-reg cells | |
| patients with lupus nephritis in remission | Patients who were previously active, but now in remission Receives: Diagnostic Test: T-reg cells | |
| normal individuals | normal healthy participants Receives: Diagnostic Test: T-reg cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
FoxP3 between groups
mean difference of FoxP3 between groups.
Measured: baseline
Association of FoxP3 and activity index
correlation between level of FoxP3 and activity index in the group with active LN.
Measured: baseline
Tregs in normal and lupus participants
mean difference of suppression capacity of Tregs between normal participants and patients with active LN.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed AbdEllah Ahmed Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428539
- Sponsor's protocol ID
- T cells in lupus LN
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36137815
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T Regulatory Cells in Lupus Nephritis
- ClinicalTrials.gov ID
- NCT06428539
- Acronym / sponsor ID
- T cells in lupus LN
- Conditions
- Lupus Nephritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with active lupus nephritis | – | Diagnostic Test: T-reg cellspatients with active lupus nephritis as active urinary sediment, or rising renal chemistry |
| patients with lupus nephritis in remission | – | Diagnostic Test: T-reg cellsPatients who were previously active, but now in remission |
| normal individuals | – | Diagnostic Test: T-reg cellsnormal healthy participants |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- adults both genders clinical diagnosis of lupus nephritis
Key exclusion criteria (1 listed)
- patients diagnosed with other renal pathologies, e.g. diabetic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-reg cellsAlso: t regulatory cellslaboratory test | Diagnostic test | normal individuals, patients with active lupus nephritis, patients with lupus nephritis in remission |
Primary outcome
FoxP3 between groups
Time frame: baseline
mean difference of FoxP3 between groups.
Association of FoxP3 and activity index
Time frame: baseline
correlation between level of FoxP3 and activity index in the group with active LN.
Tregs in normal and lupus participants
Time frame: baseline
mean difference of suppression capacity of Tregs between normal participants and patients with active LN.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Results publication: PubMed 36137815Doglio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Nephritis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed AH Hussein (+966554599271, mohammedaggag30@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FoxP3 between groups (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06428539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.