Identifying biomarkers for lupus nephritis treatment response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: tianxp6@126.com
• Phone: 86-13691165939

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.