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NCT Number: NCT06842810

Fibroblast Growth Factor 21 in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Serum FGF21 measurement by Enzyme- linked immunosorbent assay (ELISA)

Diagnostic Test

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

Primary outcomes

  1. Assessment of serum FGF21 level in SLE patients with and without nephritis in comparison to healthy controls.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2025
Registry last updated
Feb 25, 2025

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.

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