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

To investigate the possible role of TGF-β expression in renal biopsy and it's relation with fibrosis, activity and chronicity indices

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Key information

Conditions

Lupus Nephritis (LN) Autoimmune Diseases Behavior Bone Diseases Bone Diseases, Developmental Camurati-Engelmann Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Lupus Nephritis Male Urogenital Diseases Motor Activity Musculoskeletal Diseases Nephritis Osteochondrodysplasias Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Renal Biopsy

Procedure

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

Primary outcomes

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.

Secondary outcomes

clinical assessment of the patient

Time frame: 12 months

correlation with disease activity index "SLEDAI". .

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 16, 2026
Registry last updated: Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, not recruiting