NCT01316133终止4 期
A Multicenter, Non-comparative, Open-labeled, Prospective Study to Evaluate the Efficacy and Safety of Tacrolimus (Prograf®) With Steroid in Korean Lupus Nephritis Patients Who Are Non-responders to Steroid Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 37
- 主要终点
- Remission rate
研究概览
简要总结
This study is to evaluate efficacy and safety of tacrolimus with steroid by observing remission rate at 24 weeks in lupus nephritis patients who are non-responders to steroid monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who satisfy more than 4 criteria for diagnosis of systemic lupus erythematosus (ARA criteria, 1982)
- •Patients who fall under WHO class III-IV lupus nephritis on renal biopsy
- •Patients with refractory lupus nephritis
- •Proteinuria ≥ 0.5 g/day
- •Patients who took steroid ≥ 20 mg/day over one month prior to the study
- •Patients who failed a first-line therapy (non-responders to steroid monotherapy)
排除标准
- •Patients who are allergic or resistant to macrolide antibiotics or tacrolimus
- •Patients who received tacrolimus in the past (excluding drugs for external use)
- •Patients who used other immunosuppressants within 4 weeks before initiation of the study
- •Patients who have been receiving systematic chemotherapy since before enrollment (local chemotherapy is allowed.)
- •Patients with malignant tumor which developed within the recent 5 years or history of malignant tumor
- •Patients who have severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorders which may influence absorption of tacrolimus
- •Patients with S-Cr ≥ 200 µ㏖/L or ≥ 2.3 mg/dL
- •Patients with liver function levels of more than twice the upper limit of normal or acute active hepatitis
研究组 & 干预措施
Tacrolimus group
Experimental
Oral
干预措施: tacrolimus (Drug)
结局指标
主要结局
Remission rate
时间窗: 24 weeks
Percentage of the patients who shows complete remission or partial remission
次要结局
- Change from baseline in urine protein to creatinine ratio(Baseline, 4 weeks, 12 weeks and 24 weeks)
- Change from baseline in serum creatinine(Baseline, 4 weeks, 12 weeks and 24 weeks)
- Safety assessed by the incidence of adverse events, abnormal findings of laboratory tests and vital signs(for 24 weeks)
- Complete remission rate(24 weeks)
研究者
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