Status:
RECRUITING
Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics Analysis
Lead Sponsor:
Chinese SLE Treatment And Research Group
Conditions:
Lupus Nephritis
Eligibility:
All Genders
16-60 years
Brief 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' ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 5 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06167174
Start Date
December 5 2023
End Date
December 5 2028
Last Update
December 12 2023
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China