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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lupus Nephritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MMF treatment<br>Patients that have been diagnosed as III/IV ± V LN and treated with MMF 2g/d in combination with glucocorticoid. | |
| CYC treatment<br>Patients that have been diagnosed as III/IV ± V LN and treated with CYC 0.5g IV per two weeks in combination with glucocorticoid. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response of patients | The proportion of patients who achieve complete response, partial response or no response 24 weeks after baseline | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression | Clinical indices that can indicate the progression of disease, including 24-hour urinary protein, routine urine and blood tests, immune indices and patients' syndromes, will be evaluated at 4, 12, 24 weeks after baseline to monitor the progression of lupus nephritis. | 24 weeks | 
| Adverse events during the study | All adverse events, severe adverse events and proportion of patients who discontinued the treatment due to adverse events within the duration of the study. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus Nephritis