JPRN-UMIN000025328招募中未知
A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus Nephritis - Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Renal disease unrelated to SLE (e.g. diabetes mellitus, other glomerular or tubulointerstitial disease, renovascular disease), or transplanted kidney. 2. Estimated glomerular filtration rate (eGFR by MDRD) =<20 mL/min per 1.73 m2 or serum creatinine >300 micromol/L (3.39 mg/dL) at screening. 3. Renal biopsy showing cellular or fibrocellular crescent in more than 25% of glomeruli. 4. CNS or other severe organ manifestation of lupus that necessitate aggressive immunosuppressive therapy on its own. 5. Co-morbidities that require corticosteroid therapy (e.g. asthma, inflammatory bowel disease). 6. Treatment with prednisolone (or prednisone, or equivalent) at >20 mg/D for over 4 weeks within the past 3 months. 7. Treatment with MMF at >1.5 g/D for over 4 weeks within the past 3 months. 8. Known hypersensitivity or intolerability to prednisolone (or prednisone, or equivalent), TAC, or MMF at a dose of 1.25 g or below per day. 9. Subjects who are already on treatment with TAC, cyclosporine or any other calcineurin inhibitor for over 4 weeks within the past 12 months. 10. Treatment with cyclophosphamide, leflunomide, or methotrexate for over 2 weeks, or use of biological agent(s) regardless of duration, within the past 6 months (Note: prior use of azathioprine, mizoribine, intravenous immunoglobulins and anti-malarials is allowed). 11. Uncontrolled hypertension with systolic BP >160 mmHg or diastolic BP >95 mmHg. 12. Women who are pregnant or breastfeeding. 13. Women with childbearing potential or their male partners, who refuse to use an effective birth control method
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