lupus nephritis
Conditions
Interventions
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: 1. Sign the written informed consent; 2. Male or female aged 18-69; 3. Comply with the diagnostic criteria for systemic lupus erythematosus (SLE) of the American Rheumatology Association (1997); 4. Pathological diagnosis within 3 months before screening visit conforms to lupus nephritis (ISN/RPS2003 classification of lupus nephritis) type III, IV, III+V, IV+V or V (excluding CI>2 points); 5. During screening, the laboratory indicators of active nephritis meet the following conditions: Type IV: proteinuria >= 1000mg/24h; Type III/V: proteinuria >= 2000mg/24h; Renal pathological examination of tubulointerstitial lesions++; 6. Tubulointerstitial lesion: ++; 7. Both initial and recurrent cases;
Exclusion criteria
Exclusion criteria: 1. Written informed consent is not signed; 2. According to the judgment of the researcher, the patient does not need immunosuppressive treatment (except hormone); 3. Kidney transplantation has been performed or will be performed in the past; 4. Severe renal insufficiency (serum creatinine>3mg/dl,>265umo/L); 5. There are serious/progressive/uncontrollable other system symptoms or other serious complications (neuropsychiatric lupus, crescentic nephritis, thrombotic microvascular disease, etc.) related to SLE that may cause unacceptable risks to the subjects participating in this study; 6. People with cytomegalovirus (IgM), hepatitis C virus, hepatitis B virus, HIV and other viruses; 7. Abnormal liver function is measured at least twice separately (aspartate transferase, alanine transferase, or total bilirubin is more than 2.5 times of the upper limit of normal value); 8. Subjects who have participated in other drug research within 30 days; 9. Known allergy or contraindication to sirolimus, glucocorticoid, cyclophosphamide, or any component of the above drugs; 10. Those who have used cyclophosphamide and sirolimus induction therapy but have no effect; 11. Leukopenia patients who have used cyclophosphamide; 12. Alcohol or drug abuse or addiction;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy renal response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial renal response;Percentage of patients with glucocorticoid dose <=7.5 mg or <=5 mg;Complete renal response; | — |
Countries
China
Contacts
Public ContactYing Tan
Peking University First Hospital
Outcome results
None listed