lupus nephritis
Conditions
Interventions
1) Tacrolimus is usually administered orally at a dose of 3 mg/day immediately after informed consent is obtained. It is allowed to decrease the dosage and/or intermit the administration within 2 we
after that point, it is usually reduced by 2.5 mg/day every 2-4 weeks to a maintenance dosage of 5-10 mg/day. 4) Any other immunosuppressive drug (such as azathioprine, 6-mercaptoprine, cyclosporine
Sponsors
Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible if they meet all the following criteria. 1) Patients diagnosed as systemic lupus erythematosus according to the American College of Rheumatology criteria (1997). 2) Patients meeting either of the following criteria. 1. Either of the daily urinary protein (g) or the urinary protein creatinine ratio is 0.5 or more. 2. Erythrocytes or cellular casts in the urinary sediment are present. 3) Patients between 18 and 64 years of age, and providing written informed consent (if patients are less than 20 years old, their legal representatives also provide written informed consent ).
Exclusion criteria
Exclusion criteria: Patients are excluded if they meet any one of the following criteria. 1) Patients whose serum creatinine is 2 mg/dL or more; or creatinine clearance is 30 mL/min/1.73m2 or less. 2) Patients needing steroid pulse therapy. 3) Patients having received intravenous cyclophosphamide or steroid pulse therapy within 6 months of the start of the study. 4) Patients having suffered from hypersensitivity against the ingredients of tacrolimus capsules. 5) Patients administered with cyclosporine or bosentan. 6) Patients administered with potassium sparing diuretics. 7) Patients pregnant or suspected to be pregnant; or breast-feeding; or expecting to be pregnant during the study period. 8) Patients administered with pentostatin. 9) Patients having suffered from hypersensitivity against the ingredients of injectable cyclophosphamide. 10) Patients having a serious infectious disease. 11) Patients considered ineligible by a doctor in charge for other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate at 6 months after the start of protocol treatment | — |
Countries
Japan
Contacts
Public ContactTsuneo Kondo
Saitama Medical Center, Saitama Medical University Department of Rheumatology and Clinical Immunology
Outcome results
None listed