Lupus Nephritis (LN)NCT07823556
The Role of Transforming Growth Factor- Beta (TGF- β) Expression in Renal Biopsy of Lupus Nephritis Patients
A study testing renal biopsy in people with Lupus Nephritis (LN), run by Ain Shams University at 1 site in Egypt.
Trial summary
To investigate the possible role of TGF-β expression in renal biopsy and it's relation with fibrosis, activity and chronicity indices Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Lupus Nephritis (LN)
- What is being tested?
- renal biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 31 May 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- SLE patients who fulfilled EULAR/ACR 2019 Classification Criteria for Systemic Lupus Erythematosus , having lupus nephritis.
- Adult population with age group from 18 to 50 years old.
Who cannot join
- Patients with any other Rheumatological diseases such as other autoimmune CT diseases or vasculitides
- Pregnancy.
- Ongoing or previous chemotherapy treatment for cancer.
- Any other causes of CKD or AKI ( acute kidney injury).
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the possible role of TGF-β expression in renal biopsy and it's relation with fibrosis, activity and chronicity indices
Read the detailed description
Lupus nephritis (LN) is a common consequence of systemic lupus erythematosus and renal fibrosis is considered as a terminal pathway of the persistent immune-mediated insult .Transforming growth factor beta (TGF - β) is well recognized as a key player in LN fibrosis . A various number of cellular and molecular pathways have been incriminated as key players in the development of renal fibrosis, one of the most important main players involved in renal fibrogenesis is the transforming growth factor- β (TGF-β) signaling pathway. The investigators aim in this study to investigate the possible role of TGF-β expression in renal biopsy and it's relation with fibrosis, activity and chronicity indices
- Conditions
- Lupus Nephritis (LN)
- Being tested
- renal biopsy
- Keywords
- Lupus nephritis, Transforming growth factor- beta, activity and chornicity indices, renal fibrosis, renal biopsy
- Medical subject headings
- Lupus Nephritis, Camurati-Engelmann Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal biopsyProcedure or surgery
Also called Disease activity index will be calculated by using SLEDAI, IFTA score will be calculated during histopathological assessment, and also acitivity and chronicity indices
Kidney fibrosis will be assessed by means of needle core biopsy followed by histopathological assessment.
Percutaneous kidney biopsies will be performed with ultrasonic guidance under local anaesthesia by an expert nephrologist.
| Study group | Role | What they receive |
|---|---|---|
| lupus nephritis patients group ( only one group) | Other | renal biopsy will be obtained from the participants who are indicated for it. Receives: Procedure: renal biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal biopsy
to test for the presence of Transforming Growth Factor- Beta (TGF- β) in renal biopsy of patients with lupus nephritis.
All renal biopsies will be evaluated according to NIH activity and chronicity indices and fibrosis quantification according to IFTA score.
Measured: 12 months
Secondary outcomes (1)
clinical assessment of the patient
correlation with disease activity index "SLEDAI". .
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start31 May 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Nephritis (LN)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823556
- Sponsor's protocol ID
- FMASU MD204/2024
- Status last verified
- Jul 2026
- First submitted
- 14 Feb 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Transforming Growth Factor- Beta (TGF- β) Expression in Renal Biopsy of Lupus Nephritis Patients
- ClinicalTrials.gov ID
- NCT07823556
- Acronym / sponsor ID
- FMASU MD204/2024
- Conditions
- Lupus Nephritis (LN)
- Keywords
- Lupus nephritis, Transforming growth factor- beta, activity and chornicity indices, renal fibrosis, renal biopsy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 31 May 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 16 Sep 2026 (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 investigate the possible role of TGF-β expression in renal biopsy and it's relation with fibrosis, activity and chronicity indices
Detailed description
Lupus nephritis (LN) is a common consequence of systemic lupus erythematosus and renal fibrosis is considered as a terminal pathway of the persistent immune-mediated insult .Transforming growth factor beta (TGF - β) is well recognized as a key player in LN fibrosis . A various number of cellular and molecular pathways have been incriminated as key players in the development of renal fibrosis, one of the most important main players involved in renal fibrogenesis is the transforming growth factor- β (TGF-β) signaling pathway. The investigators aim in this study to investigate the possible role of TGF-β expression in renal biopsy and it's relation with fibrosis, activity and chronicity indices
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lupus nephritis patients group ( only one group) | Other | Procedure: renal biopsyrenal biopsy will be obtained from the participants who are indicated for it. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- SLE patients who fulfilled EULAR/ACR 2019 Classification Criteria for Systemic Lupus Erythematosus , having lupus nephritis.
- Adult population with age group from 18 to 50 years old.
Key exclusion criteria (4 listed)
- Patients with any other Rheumatological diseases such as other autoimmune CT diseases or vasculitides
- Pregnancy.
- Ongoing or previous chemotherapy treatment for cancer.
- Any other causes of CKD or AKI ( acute kidney injury).
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 |
|---|---|---|
| renal biopsyAlso: Disease activity index will be calculated by using SLEDAI, IFTA score will be calculated during histopathological assessment, and also acitivity and chronicity indicesKidney fibrosis will be assessed by means of needle core biopsy followed by histopathological assessment. Percutaneous kidney biopsies will be performed with ultrasonic guidance under local anaesthesia by an expert nephrologist. | Procedure or surgery | lupus nephritis patients group ( only one group) |
Primary outcome
renal biopsy
Time frame: 12 months
to test for the presence of Transforming Growth Factor- Beta (TGF- β) in renal biopsy of patients with lupus nephritis. All renal biopsies will be evaluated according to NIH activity and chronicity indices and fibrosis quantification according to IFTA score.
1 secondary outcome
clinical assessment of the patient
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing renal biopsy in people with Lupus Nephritis (LN), run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal biopsy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2026.