Systemic Lupus ErthematosusNCT06842810
Fibroblast Growth Factor 21 in Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erthematosus, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erthematosus
- What is being tested?
- Serum FGF21 measurement by Enzyme- linked immunosorbent assay (ELISA)
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 31 Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * 50 SLE patients with lupus nephritis * 25 SLE patients without lupus nephritis * 20 healthy controls
Who may be able to join
- 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.
Who cannot join
- 1-SLE Patients < 18 years old. 2- Patients with other rheumatic diseases or overlap syndromes. 3- Patients with malignancy. 4- Patients with liver diseases.
About this study
Official title: 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.
- Conditions
- Systemic Lupus Erthematosus
- Being tested
- Serum FGF21 measurement by Enzyme- linked immunosorbent assay (ELISA)
- Keywords
- SLE, Fibroblast growth factor 21
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| SLE cases with lupus nephritis | Not described Receives: Diagnostic Test: Serum FGF21 measurement by Enzyme- linked immunosorbent assay (ELISA) | |
| SLE cases without lupus nephritis | Not described Receives: Diagnostic Test: Serum FGF21 measurement by Enzyme- linked immunosorbent assay (ELISA) | |
| Healthy controls | Not described Receives: Diagnostic Test: Serum FGF21 measurement by Enzyme- linked immunosorbent assay (ELISA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of serum FGF21 level in SLE patients with and without nephritis in comparison to healthy controls.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErthematosusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Sayed Ibrahim Abdelrahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842810
- Sponsor's protocol ID
- Fibroblast growth factor 21
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Fibroblast Growth Factor 21 Levels in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06842810
- Acronym / sponsor ID
- Fibroblast growth factor 21
- Conditions
- Systemic Lupus Erthematosus
- Keywords
- SLE, Fibroblast growth factor 21
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SLE cases with lupus nephritis | – | Diagnostic Test: Serum FGF21 measurement by Enzyme- linked immunosorbent assay (ELISA) |
| SLE cases without lupus nephritis | – | Diagnostic Test: Serum FGF21 measurement by Enzyme- linked immunosorbent assay (ELISA) |
| Healthy controls | – | Diagnostic Test: Serum FGF21 measurement by Enzyme- linked immunosorbent assay (ELISA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * 50 SLE patients with lupus nephritis * 25 SLE patients without lupus nephritis * 20 healthy controls
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1-SLE Patients < 18 years old. 2- Patients with other rheumatic diseases or overlap syndromes. 3- Patients with malignancy. 4- Patients with liver diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | Healthy controls, SLE cases with lupus nephritis, SLE cases without lupus nephritis |
Primary outcome
Assessment of serum FGF21 level in SLE patients with and without nephritis in comparison to healthy controls.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erthematosus, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of serum FGF21 level in SLE patients with and without nephritis in comparison to healthy controls. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.