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

September 13, 2026 updated by: Ain Shams University
To investigate the possible role of TGF-β expression in renal biopsy and it's relation with fibrosis, activity and chronicity indices

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University

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

Accepts Healthy Volunteers

No

Description

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:

  • 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).

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: lupus nephritis patients group ( only one group)
renal biopsy will be obtained from the participants who are indicated for it.
Procedure: renal 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.

Other Names:
  • Disease activity index will be calculated by using SLEDAI
  • IFTA score will be calculated during histopathological assessment, and also acitivity and chronicity indices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical assessment of the patient
Time Frame: 12 months
correlation with disease activity index "SLEDAI". .
12 months

Collaborators and Investigators

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

Sponsor

Ain Shams University

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 (Actual)

May 31, 2026

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

September 13, 2026

First Posted (Actual)

September 16, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD204/2024

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.

Subscribe