Fibroblast Growth Factor 21 in Systemic Lupus Erythematosus

Evaluation of Serum Fibroblast Growth Factor 21 Levels in Patients With Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic disorder characterized by profound immune and metabolic disturbances. It emerges due to a complex interplay of genetic and environmental factors. Alteration in immune cell metabolism is another feature of SLE. Mitochondria, serving as the main regulator of cell metabolism, exhibits pronounced dysfunction in SLE patients.

Kidneys are among the most frequently affected organs in SLE, with 30-40% of patients developing lupus nephritis (LN) over the course of their disease. LN patients exhibit varying degrees of renal injury, significantly reducing their survival rate. Usually, LN originates from abnormal immune responses, resulting in the formation and deposition of immune complexes in the kidneys, triggering the release of pro-inflammatory cytokines, cell adhesion molecules, and chemokines, thereby inducing inflammation. Extensive glomerular mitochondrial damage has been reported in kidney biopsies obtained from patients with LN. So, identifying peripheral immune markers of mitochondrial dysfunction may be beneficial in assessing SLE activity and the extent of organ involvement.

Among these markers, fibroblast growth factor 21 (FGF-21) is one of the circulating immune markers which is expressed in response to mitochondrial stress. FGF-21 is known to be primarily produced in the liver, but under stress conditions, it can also be produced by the kidneys. In addition, it correlates with the degree of renal impairment in various kidney diseases.

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Lupus Erthematosus
• Intervention / Treatment: Diagnostic test: Serum FGF21 measurement by Enzyme- linked immunosorbent assay (ELISA)

• Study Type: Observational
• Enrollment (Estimated): 95

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

• 50 SLE patients with lupus nephritis
• 25 SLE patients without lupus nephritis
• 20 healthy controls

Description

Inclusion Criteria:

- 1- Patients who will be diagnosed as SLE according to the 2019 EULAR/ACR Classification criteria for Systemic Lupus Erythematosus.

2-SLE Patients > 18 years old.

Exclusion Criteria:

• 1-SLE Patients < 18 years old. 2- Patients with other rheumatic diseases or overlap syndromes. 3- Patients with malignancy. 4- Patients with liver diseases.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy controls	Diagnostic test: Serum FGF21 measurement by Enzyme- linked immunosorbent assay (ELISA); Venous 5 ml blood will be collected, then centrifugation at the speed of 2000-3000 rpm for 20-min., supernatant will be collected and stored at -20°C for later analysis then tha sample will be tested for fibroblast growth factor 21
SLE cases with lupus nephritis	Diagnostic test: Serum FGF21 measurement by Enzyme- linked immunosorbent assay (ELISA); Venous 5 ml blood will be collected, then centrifugation at the speed of 2000-3000 rpm for 20-min., supernatant will be collected and stored at -20°C for later analysis then tha sample will be tested for fibroblast growth factor 21
SLE cases without lupus nephritis	Diagnostic test: Serum FGF21 measurement by Enzyme- linked immunosorbent assay (ELISA); Venous 5 ml blood will be collected, then centrifugation at the speed of 2000-3000 rpm for 20-min., supernatant will be collected and stored at -20°C for later analysis then tha sample will be tested for fibroblast growth factor 21

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of serum FGF21 level in SLE patients with and without nephritis in comparison to healthy controls.	2 years

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: SLE; Fibroblast growth factor 21
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: Fibroblast growth factor 21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No