Identifying biomarkers for lupus nephritis treatment response

Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics

This study is trying to find specific markers in blood and urine that can help predict how well people with lupus nephritis will respond to certain treatments.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 16 Years to 60 Years
• Sex: All
• Sponsor: Chinese SLE Treatment And Research Group (Academic / other)
• Drugs / interventions: methotrexate, prednisone, cyclophosphamide
• Locations: 1 site (Beijing)
• Trial ID: NCT06167174 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients with lupus nephritis to identify biomarkers that can predict their response to immunosuppressive treatments. The study will collect peripheral blood, kidney tissues, and urine samples from 100 patients before and after treatment with mycophenolate mofetil or cyclophosphamide, combined with glucocorticoids. Advanced multi-omics analyses, including single-cell RNA sequencing, ATAC-seq, and CITE-seq, will be utilized to discover new biomarkers related to treatment response and prognosis.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 16-60 with a confirmed diagnosis of lupus nephritis who have not previously received glucocorticoids or immunosuppressants.

Not a fit: Patients with other autoimmune diseases or severe organ involvement may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with lupus nephritis.

How similar studies have performed: Other studies have shown promise in identifying biomarkers for autoimmune diseases, but this specific multi-omics approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age between 16-60 years.
2. Fulfilling the 2012 SLICC classification for SLE.
3. Renal biopsy pathology was clearly classified as III \\ IV \\ V+III \\ V+IV within 6 months.
4. Renal biopsy reveals active disease.
5. 24-hour urinary protein was tested twice within two weeks, both of which were greater than 1g.
6. The patients have never received glucocorticoid/immunosuppressants or received standard treatment for more than 1 month without change. The standard treatment should fulfill: a. prednisone 0-20mg/day, or equivalent other glucocorticoids; b. acceptable immunosuppressants, including Tacrolimus ≤ 4mg/d, methotrexate ≤ 15mg/week, azathioprine ≤ 100mg/d and MMF ≤ 1g/d.
7. Informed consent obtained.

Exclusion Criteria:

1. Other concomitant connective tissue diseases or autoimmune diseases.
2. Neuropsychiatric lupus, alveolar hemorrhage, retinal lesions, pulmonary arterial hypertension, or other severe organ involvement.
3. Pregnant or lactating women.
4. Current infections that require antibiotic or antiviral treatment.
5. Other kidney diseases.
6. Platelet \< 50×10\^9/L.
7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that is greater than 1.5 times the upper limit of the normal value.
8. Total bilirubin or blood lipid that is greater than 2 times the upper limit of the normal value.
9. Other conditions that not suitable for inclusion in the study, assessed by the investigators.

Where this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Xinping Tian, MD — Peking Union Medical College Hospital
• Study coordinator: Xinping Tian, MD

Conditions Lupus Nephritis