Metformin In Prevention Of Lupus Nephritis In High Risk Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Prevention of new-onset LN
研究概览
简要总结
Lupus nephritis (LN) is a main manifestation of systemic lupus erythematosus (SLE), which will largely effect the prognosis of SLE patients. Our previous 10-year data showed that the development of LN is most common in the first year of SLE, occupying about 17%. And our group has established a prediction model to predict the 1-year probability of LN for SLE patients without renal involvement. Our previous proof-of-concept trial and multicenter, randomized, double-blind, placebo-controlled trial indicated that metformin seemed to have potential to reduce the new-onset of LN in SLE patients (Unpublished data, in review). So the investigators tried to illustrate whether metformin has effect to prevent the development of lupus nephritis in high risk SLE patients based on LN prediction model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New-onset of SLE (within 1 year)
- •Meet the 1997 ACR criteria of SLE
- •1-year risk of developing LN higher than 50% based on LN prediction model.
- •All the patients received standard care of therapy. (mycophenolate/azathioprine/cyclosporin/tacrolimus/methotrexate/leflunomide were allowed).
- •Sign the informed consent.
排除标准
- •Patients with kidney involvement at screening were excluded
- •Patients with severe SLE were excluded, such as neuropsychiatric and cardiac involvement
- •Cyclophosphamide or biologics were not allowed.
- •Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2 times upper normal limits; creatinine clearance rate < 60ml/min;
- •Previous exposure of metformin within 30 days before screening; or previous history of intolerant to metformin;
- •Patients who diagnosed of diabetes mellitus;
- •Pregnancy or lactation.
研究组 & 干预措施
Placebo
干预措施: Metformin (Drug)
Metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Prevention of new-onset LN
时间窗: 12 months
Percentage of patients with new-onset lupus nephritis
次要结局
- Change of proteinuria(12 months)
- Time to onset of LN(12 months)
- Change of SLEDAI score(12 months)
- Change of Prednisone(12 months)