NCT01056237已完成不适用
Research Institute of Nephrology, Jinling Hospital,
Zhi-Hong Liu, M.D.1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- To compare the efficacy and safety of multi-target therapy as maintenance treatment for lupus nephritis with Aza.
研究概览
简要总结
An multi-site, randomized, prospective study to compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment versus CTX- Aza therapy.
详细描述
Azathioprine (AZA) has been used for maintenance therapy of lupus nephritis for many years. We compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment vs CTX-Aza.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who signed written informed consent form
- •SLE patient, aged between 18-65 years, female or male;
- •Patients diagnosed lupus nephritis according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy
- •All patients had received induction therapy for 6 months with multi-therapy (FK506 + MMF) or intravenous CTX pulses.
- •Patients were recruited when received partial remission or complete remission after 6 months induction therapy.
- •Complete remission: proteinuria <0.4 g/24h, negative urine sediment, serum albumin >35 g/L, elevated scr <0.3mg/dl, no extra-renal complications; Partial remission: proteinuria <1.0 g/24h, urine RBC <50X104/ml without casts, serum albumin > 30 g/L, elevated Scr <0.3mg/dl,no extra-renal complications.
排除标准
- •Patients who didn't sign written informed consent form or could not obey the protocol.
- •Patients who didn't received the CR or PR criterion.
- •Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis.
- •WBC <3000/mm3 in peripheral blood .
- •Patients with central nervous system symptoms. -
研究组 & 干预措施
Multi-target therapy
Experimental
(Tarcrolimus+mycophenolate mofetil)
干预措施: Multi-target therapy (Drug)
Azathioprine
Active Comparator
Aza
干预措施: Azathioprine (Drug)
结局指标
主要结局
To compare the efficacy and safety of multi-target therapy as maintenance treatment for lupus nephritis with Aza.
时间窗: 18 months
次要结局
未报告次要终点
研究者
Zhi-Hong Liu, M.D.
professor
Nanjing University School of Medicine
研究点 (1)
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