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Active, not recruitingNCT07823556Updated Sep 16, 2026

The Role of Transforming Growth Factor- Beta (TGF- β) Expression in Renal Biopsy of Lupus Nephritis Patients

An interventional study of renal biopsy in Lupus Nephritis (LN), sponsored by Ain Shams University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Ain Shams University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Lupus Nephritis with a site in Egypt — 8 open to participants now, 9 under way, none of them phase 3. Lupus Nephritis · Egypt.

Planned enrollment
9th of 10
30 · median 63
Started
2026
with 1 other
No phase
2 of 20
none open now
Registered
17th of 20
by date
Lead sponsor
4 of 20
Ain Shams University

Among the 20 studies in Lupus Nephritis with a site in Egypt, this one is the 9th largest by planned enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2026, is one of 2 with no phase, and was the 17th registered.

Lupus Nephritis

340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.

Browse Lupus Nephritis studies →

Open to participants now

8 of the 20 studies in Lupus Nephritis with a site in Egypt are open now. Recruiting first, the newest first:

3 more — sign in →

All 8 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 88 Lupus Nephritis studies recruiting now, 30 (34%) set no upper age limit and 51 (58%) stop at 75 or younger; 29 take children under 18; 7 take healthy volunteers.

This study: 18 Years to 50 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 20 studies in Lupus Nephritis with a site in Egypt, or all of them as a file.
02

Study summary

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

03

Conditions studied

  • Lupus Nephritis (LN)

Keywords

  • Lupus nephritis
  • Transforming growth factor- beta
  • activity and chornicity indices
  • renal fibrosis
  • renal biopsy
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patients with any other Rheumatological diseases such as other CT diseases or vasculitides
  • Pregnancy.
  • Ongoing or previous chemotherapy treatment for cancer.
  • Any other causes of CKD or AKI ( acute kidney injury).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    lupus nephritis patients group ( only one group)

    renal biopsy will be obtained from the participants who are indicated for it.

    Procedure: renal biopsy

Interventions

  • Procedurerenal biopsy

    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.

    Also known as: Disease activity index will be calculated by using SLEDAI, IFTA score will be calculated during histopathological assessment, and also acitivity and chronicity indices

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

Secondary outcomes

  1. clinical assessment of the patient

    correlation with disease activity index "SLEDAI". .

    Time frame: 12 months

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2026 (actual). Primary completion is estimated for Jul 2027, 13 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2025
First posted
Sep 16, 2026
StartActual
May 31, 2026
Primary completionEst.
Jul 30, 2027
CompletionEst.
Sep 30, 2027
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07823556
Responsible party
Sponsor
First posted
Sep 16, 2026
Start date
May 31, 2026
Primary completion
Jul 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Sep 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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