NCT00429377已完成3 期
Phase 3 Study of Tacrolimus(FK506)for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 7
- 主要终点
- Change of Lupus Nephritis - Disease Activity Index total score
研究概览
简要总结
This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 16 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Steroid refractory lupus nephritis
- •more than 10mg of steroid failed to control disease activity
- •patients who failed to reduce the amount of steroid
- •patients who couldn't increase the amount of steroid due to side effects
排除标准
- •Patients who started the immunosuppressant therapy or increased the amount of immunosuppressant within 12 weeks prior to test drug administration
- •Patients who received cyclophosphamide puls within 24 weeks prior to test drug administration
- •CNS( Central Nerve System) Lupus patients
- •hepatic failure patients
- •Serum creatinine ≧1.5mg/dL
研究组 & 干预措施
未命名试验
干预措施: tacrolimus (Drug)
结局指标
主要结局
Change of Lupus Nephritis - Disease Activity Index total score
次要结局
- proteinuria, RBC-urine, serum creatinine, anti ds-DNA antibody, complement (C3)
研究者
研究点 (7)
Loading locations...
相似试验
已完成
3 期
Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis PatientsUlcerative ColitisNCT00347048Astellas Pharma Inc62
已完成
2 期
A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy PatientsIgA NephropathyNCT01224028Astellas Pharma Inc40
已完成
4 期
Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous NephritisLupus Erythematosus, SystemicLupus NephritisNCT00125307Chinese University of Hong Kong20
已完成
不适用
Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V)Lupus NephritisNCT00298506Nanjing University School of Medicine120
已完成
2 期
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant PatientsKidney TransplantationNCT00282568Astellas Pharma Inc70