Severe Lupus Nephritis (Class III, IV, V+III, V+IV)
Conditions
Interventions
study group:Tactrolimus administrated orally
control group:CTX administrated intravenousely
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) SLE patients aged 18-60 years, diagnosis consistent with the 1997 American College of Rheumatology diagnostic criteria for SLE. SLE disease activity index (SLE-DAI)> 10 points; (2) Biopsy given, pathology severe type III, IV type, V+III type and V+IV-type LN (WHO2004 Year-type standard, heavy-III, with severe segmental lesions that have loop necrosis or crescent formation of the III-type LN), there is significant activity in renal disease; (3) Proteinuria >= 2g/24h, with active urine sediment (urine RBC> 400000/ml, tube urine, leukocytes in urine), Scr <3mg/dl (265umol/L); (4) Good compliance; (5) Signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Almost 3 months had received cyclophosphamide (CTX), mycophenolate mofetil, cyclosporin A, Hook, leflunomide and other drug treatment (more than 1 week). (2) Serum creatinine> 265umol / L. (3) With severe complications such as infection, central nervous system symptoms. (4) Sustained abnormal liver function, ALT or AST twice higher than upper limit of normal, or HBsAg, or HCV-Ab positive. (5) Abnormal glucose metabolism. (6) Pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal biopsy renal pathological outcomes;Side effects;Clinical efficacy: rate of complete remission + partial remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine protein;Serum creatinine, antibody and complement changes;Serum albumin; | — |
Countries
China
Contacts
Public ContactChanglin Mei
Outcome results
None listed