systemic lupus erythematosus
Conditions
Interventions
Experimental group:None
Control group:None
Sponsors
Shanghai Jiao Tong University School of Medicine,Renji Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Experimental group 1. Male or female aged 14-85 years (including boundary value); 2. Clinically diagnosed with systemic lupus erythematosus (SLE) according to the 1997 American College of Rheumatology (ACR) classification criteria; 3. Positive results of previous ANA, anti-dsDNA or anti-Sm tests; 4. Presence of active, biopsy-proven lupus nephritis type III, IV, or V according to the 2003 International Society of Nephrology/Society of Renal Pathology (ISN/RPS) typing criteria, the biopsy must be performed within 1 year prior to baseline or at baseline, and the biopsy report is used to confirm whether the patient can be included in the study; 5. Active kidney disease at baseline, defined as a > urine protein/creatinine ratio = 1 mg/mg (or 24h urine protein >=1 g); Control group 1. Male or female aged 14-85 years (including boundary value); 2. Clinically diagnosed with systemic lupus erythematosus (SLE) according to the 1997 American College of Rheumatology (ACR) classification criteria; 3. Positive results of previous ANA, anti-dsDNA or anti-Sm tests; 4. No active kidney disease, negative urine protein or 24-hour urine protein < 500 mg.
Exclusion criteria
Exclusion criteria: 1. Patients with severe renal insufficiency or dialysis, i.e., estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula < 30 mL/min/1.73 m^2; 2. There are situations that significantly affect the level of complement-related biomarkers in the judgment of the investigator, including but not limited to patients who are using or have used complement inhibitors within 3 months before baseline, have a history of viral infection within 1 month before baseline, or have positive Epstein-Barr virus (EBV) or cytomegalovirus (CMV) DNA test results; 3. Other situations that are not suitable for inclusion in this study according to the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dsDNA;Complement component 3, C3;Complement component 4, C4;Complement component 1, q subcomponent, C1q;Complement factor Bb;Complement component 5a, C5a;Mannose-Binding Lectin, MBL;Complement component 4d, C4d;creatine;24-hour urine protein; | — |
Countries
China
Contacts
Public ContactHuihua Ding
Shanghai Jiao Tong University School of Medicine,Renji Hospital
Outcome results
None listed