Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics Analysis
Recruiting · NCT06167174 · Observational (researchers observe without assigning treatment) · Lead sponsor: Chinese SLE Treatment And Research Group
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
16 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Peking Union Medical College Hospital - Beijing, China