Molecular Biomarkers for Discriminating Lupus Nephritis in SLE

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - 65 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

40 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Lupus nephritis (LN) is a major cause of renal morbidity in systemic lupus erythematosus (SLE). Conventional clinical, renal, and serological parameters may not fully distinguish patients with renal involvement from those with SLE without LN. This cross-sectional observational study aims to evaluate a predefined panel of eight molecular biomarkers and determine their ability to discriminate between patients with established SLE with and without LN. The panel includes the non-coding RNA markers MALAT1, GAS5, miR-155, and miR-223; the inflammatory biomarkers interferon-beta (IFN-β), lipocalin-2 (LCN2), and interleukin-23 (IL-23); and the tissue-remodeling biomarker matrix metalloproteinase-9 (MMP-9). The study will also assess associations between these biomarkers and conventional clinical and laboratory parameters, disease activity, cumulative organ damage, and available renal histopathological findings. The discriminatory performance of conventional clinical assessment, the molecular biomarker panel, and their integrated combination will be evaluated.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Adults aged 18 years or older.
• Patients with an established diagnosis of systemic lupus erythematosus (SLE), according to the diagnostic/classification criteria adopted by the treating clinicians and documented in the medical records.
• Patients classified into either of the following groups:

SLE with established lupus nephritis (LN). SLE without evidence of lupus nephritis.

• Availability of clinical and laboratory data sufficient for characterization of SLE disease status and renal involvement.
• Availability of blood samples suitable for the planned molecular biomarker assessment.

Exclusion Criteria:

• Patients with an uncertain or undocumented diagnosis of SLE.
• Patients with an unclear renal status that prevents reliable classification into the LN or non-LN group.
• Patients with another active autoimmune or systemic inflammatory disease that could substantially interfere with interpretation of the investigated biomarkers.
• Patients with an active infection at the time of sample collection.
• Patients with a concurrent malignancy or another major condition likely to substantially affect the measured inflammatory or molecular biomarkers.
• Patients with insufficient clinical information or inadequate biological samples for the planned analyses.

Study population

Adult patients with an established diagnosis of SLE attending or receiving care at the participating center(s) were considered for inclusion. Eligible participants were classified into two groups according to the presence or absence of clinically established LN: SLE+LN group; patients with SLE and LN and SLE Group; patients with SLE without LN.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (0)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

No locations are listed. Use the official study contact.

Study team and timeline

Lead sponsor

Egyptian Chinese University

Study start

Oct 25, 2026 Estimated

Primary completion

Dec 1, 2026 Estimated

Study completion

Jan 1, 2027 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts