lupus nephritis
Conditions
Interventions
Group 1 :
Group 2:
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years old, gender is not limited; 2. Patients with definite diagnosis of SLE, that is, meeting the SLE classification criteria revised by the American College of Rheumatology in 1997 or the SLE diagnostic classification criteria issued by EULAR/ACR in 2019; 3. Patients with lupus nephritis of type III and type IV (with or without type V) or simple type V lupus nephritis confirmed by biopsy within 6 months defined by the 2003 ISN/RPS criteria; only biopsy specimens showing active lesions or activities are recruited Patients with sexual and chronic diseases; 4. ANA titer >= 1:80 and/or positive anti-dsDNA antibody; 5. Urine protein-to-creatinine ratio (UPCR) >= 1.0 mg/mg (and/or equivalent 24h urine protein level); 6. Receive routine treatment for at least 3 months before enrollment, and the decrease in urine protein is less than 25%; 7. Volunteer to participate in this research and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. eGFR < 30 mL/min/1.73m2; 2. Patients who need dialysis or kidney transplantation; 3. Patients who have previously received biological agents; 4. Patients who have previously received mesenchymal stem cell therapy; 5. Those who are known to be allergic to the study drug; 6. Women who are pregnant or are about to become pregnant in the near future, and breastfeeding women; 7. Patients with central nervous system lupus and thrombotic microangiopathy; 8. Patients who are currently suffering from active hepatitis or have had serious liver lesions or medical history; 9. Patients with immunodeficiency, uncontrolled severe infection and active or recurrent peptic ulcer; 10. Subjects who are participating in clinical research of other drugs; 11. The investigator judges that there are other reasons for not being suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving a primary renal efficacy response (PERR); | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour proteinuria;Proportion of patients achieving complete renal response (CRR);Proportion of patients achieving clinical complete remission and partial remission; | — |
Countries
China
Contacts
Public ContactSun Lingyun
Nanjing Drum Tower Hospital
Outcome results
None listed