sever lupus nephritis
Conditions
Interventions
Group A:NIH standard program (Induction period, follow-up once every four weeks
consolidation therapy: follow-up once every twelve weeks, maintaince therapy: follow-up once every twelve weeks
Group B:Intensive group: mini-pulse of cyclophosphamid, hydroxycholoquin and another immunosupressive agent, such as mycophenolate, leflunomide, azathioprine or Methotrexate)
Sponsors
The department of Rheumotology and Immunology, People’s Hospital, Peking University.
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Meet the 1997 ACR classfication criteria of systemic lupus erythematosus: Lupus nephritis definition: 24 hours proteinuria (>=3.0g/day or +++), erythrocyturia>5/HPF, leucocyturia or cast (red blood cell, hemoglobin, tubuli or mixed); 2. Age between 18 to 60 years old; 3. SLEDAI score>=10; 4. In the income group of the first 6 months, renal biopsy proved lupus nephritis (non-essential condition, as far as possible); 5. Signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergic to cyclophosphamide and hydroxychloquine; 2.Severe infection disease and neuro-psychiatric lupus; 3.Hepatic lesion (glutamate-pyruvate transaminase or glutamic oxalacetic transaminase more than double of the normal level); renal lesion(creatinine more than the upper limit of the normal value) 4.WBC<4*10^9/L or PLT<100*10^9/L; 5.Pregnance or lactation; 6.History of malignant disease and not meeting the following condition (succesfully treated basal cell carcinoma, other succesfully treated tumor and no replase evidence five years before screening); 7.Hepertatis B virus carrier or chronic hepertitis B; 8.Defect of field vision, monoocular fucttion or cataract; 9.Decompensated heart failure or sever hypertension; 10. Paticipation in other cilinical trial within 4weeks; 11. Application of immunosupressive agents within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum albumin;Serum creatine;24-hour urine protein; | — |
Secondary
| Measure | Time frame |
|---|---|
| SLEDAI score; | — |
Countries
China
Contacts
Public ContactZhanguo Li
Outcome results
None listed