NCT00298506已完成不适用
An Open, Prospective Study to Assess the Efficacy and Safety of FK506 Combined MMF in the Treatment of Class III，IV，V + IV or V + III Lupus Nephritis
Nanjing University School of Medicine2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2005年9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
- 120
- 试验地点
- 2
- 主要终点
- To assess the efficacy of FK506 combined with MMF versus intravenous CTX pulses in treatment of LN
研究概览
简要总结
This is an open, prospective study to assess the efficacy and safety of Tacrolimus (FK506) combined with MMF in the treatment of class III, IV, V + IV or V + III lupus nephritis.
详细描述
- To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment of class Ⅲ, Ⅳ, Ⅴ + Ⅳ or Ⅴ + Ⅲ LN.
- To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ, Ⅳ, Ⅴ + Ⅳ or Ⅴ + Ⅲ LN.
- To explore the dosing of FK506 combined with MMF and their effective range of blood concentration.
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
- 12 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients with a diagnosis of systemic lupus erythematosus (SLE) according to the criteria of American Rheumatic Association, 1982, aged between 12-50 years, with score of SLE-DAI (Disease Active Index) of more than 12 (not including class V LN).
- •Patients diagnosed according to ISN/RPS 2003 classification criteria: class Ⅲ, Ⅳ, Ⅳ + Ⅴ, Ⅲ + Ⅴ LN by renal biopsy within 3 months, CI< 4，Scr< 3 mg/dl.
- •Patients with a proteinuria ≥ 1.5 g/24h, or active urine sediment.
- •Patients who signed written informed consent forms (patients less than 18 years old with their parents/legal representative' signatures), and have given their consent to follow all study procedures and follow-ups.
排除标准
- •Patients who have received treatment of cytotoxic drugs such as cyclophosphamide (CTX), cyclosporine A for more than 1 week within three months.
- •Patients with serum creatinine ≥ 3 mg/dl（265 μmol/L).
- •Patients with severe infection or central nervous system symptoms.
- •Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis.
- •Patients who have abnormal blood glucose, with a fasting blood glucose > 6.2 mmol/L or post meal blood glucose > 11.2 mmol/L.
- •Patients who are pregnant or lactating.
- •Patients who are known to be allergic to a macrolide.
研究组 & 干预措施
FK506+MMF
Active Comparator
干预措施: Multitherapy (Drug)
结局指标
主要结局
To assess the efficacy of FK506 combined with MMF versus intravenous CTX pulses in treatment of LN
时间窗: 18 months
次要结局
- To investigate the safety and tolerability of FK506 combined with MMF versus intravenous CTX pulses(18 months)
研究者
Zhi-Hong Liu, M.D.
Research Institute of Nephrology
Nanjing University School of Medicine
研究点 (2)
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