Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics Analysis
Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics
Chinese SLE Treatment And Research Group
100 participants
Dec 5, 2023
OBSERVATIONAL
Conditions
Summary
This is an observational study of patients with lupus nephritis aiming to find biomarkers that can predict patients' response to immunosuppressants. We planed to collect 100 lupus nephritis patients' peripheral blood,kidney tissues and urine before and after treatment (mycophenolate mofetil or cyclophosphamide, in combination with glucocorticoids). Then multi omics analysis, including single cell RNA-seq, ATAC-seq and CITE-seq, will be performed to find new biomarkers for patients' response and prognosis.
Eligibility
Inclusion Criteria7
- Age between 16-60 years.
- Fulfilling the 2012 SLICC classification for SLE.
- Renal biopsy pathology was clearly classified as III \\ IV \\ V+III \\ V+IV within 6 months.
- Renal biopsy reveals active disease.
- 24-hour urinary protein was tested twice within two weeks, both of which were greater than 1g.
- 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.
- Informed consent obtained.
Exclusion Criteria9
- Other concomitant connective tissue diseases or autoimmune diseases.
- Neuropsychiatric lupus, alveolar hemorrhage, retinal lesions, pulmonary arterial hypertension, or other severe organ involvement.
- Pregnant or lactating women.
- Current infections that require antibiotic or antiviral treatment.
- Other kidney diseases.
- Platelet < 50×10\^9/L.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that is greater than 1.5 times the upper limit of the normal value.
- Total bilirubin or blood lipid that is greater than 2 times the upper limit of the normal value.
- Other conditions that not suitable for inclusion in the study, assessed by the investigators.
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06167174