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

NCT07823556 | Active Not Recruiting

• 1 other identifier: FMASU MD204/2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Keywords

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

Outcome Measures

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.

  12 months

Secondary Outcomes (1)

• clinical assessment of the patient

  12 months

Study Arms (1)

lupus nephritis patients group ( only one group)

OTHER

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

Procedure: renal biopsy

Interventions

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.

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

lupus nephritis patients group ( only one group)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Lupus Nephritis; Camurati-Engelmann Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: September 16, 2026
• Study Start: May 31, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-07

Locations

EG (1)