NCT01042457已完成3 期
Concentration-controlled Therapy of Mycophenolate Mofetil (MMF) in Proliferative Lupus Nephritis
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
- 24
- 试验地点
- 1
- 主要终点
- Response rate of Mycophenolic acid concentration-controlled therapy in active lupus nephritis patients at 6th month
研究概览
简要总结
To evaluate therapeutic response to MMF treatment in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis. Mycophenolic acid levels at 1-hour post dose will be monitored monthly up to 6 months.
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16-60 years.
- •Ability and willingness to provide written informed consent (or to obtain consent from parent guardian where applicable) and to comply with the schedule of protocol requirements
- •Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE. The 4 criteria do not have to be present at the time of screening
- •Active lupus nephritis defined as follows: Biopsy proven (within 16 weeks prior to screening) ISN Class III or IV (A or A/C) not include III(C) IV(C) and VI (>90% chronic irreversible scarring)
排除标准
- •Relates to SLE
- •Severe renal impairment as defined by calculated creatinine clearance or MDRD-GFR < 30 ml/min(except creatinine clearance or MDRD-GFR > 50 ml/min in the 12 weeks prior to screening)
- •History of serious disease or complication in any organ system that not appropriate to treatment immunosuppressive drug groups.
- •Related to Treatment
- •Previous of any Mycophenolate groups in the 3 months prior to screening.
- •Treatment with more than 2 g Cyclophosphamide in the last 6 months period prior to screening.
- •Receipt of more than 3 g IV pulse methylprednisolone within the last 3 months prior to screening.
- •Receipt of prednisolone dose > 30 mg/day for longer than 30 days within last 3 months prior to screening.
- •Related to General Health
- •Pregnancy or breast feeding mothers.
- •Evidence of significant uncontrolled concomitant disease in any organ system not related to SLE.
- •History of cancer, including solid tumors, hematological malignancies and carcinoma.
- •History of serious recurrent or chronic infection.
- •Evidence of current abuse of drugs or alcohol.
- •Related to Laboratory Findings
- •Neutrophile < 1,500/mm3, Hb < 7g/L, Platelet < 50,000/mm3 (except active SLE)
- •Positive HBsAg or anti-HCV or anti-HIV.
研究组 & 干预措施
Mycophenolate mofetil
Other
干预措施: Mycophenolate mofetil (Drug)
结局指标
主要结局
Response rate of Mycophenolic acid concentration-controlled therapy in active lupus nephritis patients at 6th month
时间窗: 24 weeks
次要结局
- To determine Mycophenolic acid level related side effect.(24 weeks)
研究者
研究点 (1)
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