About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
All patients visit Rheumatology and Immunology Department of Peking Union Medical College Hospital and fulfill the inclusion criteria.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Treatment response of patients
The proportion of patients who achieve complete response, partial response or no response 24 weeks after baseline
Secondary outcomes
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.
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.
Sponsors and contacts
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