Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics Analysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lupus Nephritis. Basic parameters: 16 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics
Overview
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.
Primary outcome measures
- Treatment response of patients [Time frame: 24 weeks]
Secondary outcome measures (2)
- Disease progression [Time frame: 24 weeks]
- Adverse events during the study [Time frame: 24 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT06167174 · CSTAR-K2939