Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in 24-hour urinary protein excretion
研究概览
简要总结
The investigators study the efficacy and safety of tacrolimus in the treatment of membranous nephritis secondary to systemic lupus erythematosus.
详细描述
Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (SLE). The treatment of membranous (type V) lupus nephritis, a subset that carries a high morbidity, remains unsatisfactory. Recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of T-helper cells, for example, tacrolimus, may be effective in the treatment of primary membranous nephropathy. The investigators plan to conduct an open-label single-arm study of the efficacy and safety of tacrolimus in the treatment of membranous nephropathy secondary to SLE. Twenty patients with biopsy-proven membranous nephropathy secondary to SLE will be recruited. They will be treated with oral prednisolone and tacrolimus for 6 months, followed by 6 months of maintenance steroids alone. Proteinuria, renal function, clinical and serologic lupus activity will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.5 gm/day. This study will explore the potential role of tacrolimus in the treatment of membranous lupus nephritis, which is usually resistant to conventional therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfill the revised American College of Rheumatology criteria for SLE
- •Have biopsy-proven membranous nephropathy secondary to SLE
- •Nephrotic syndrome with proteinuria (> 3 g/day) and serum albumin < 30 g/dl, with or without active urinary sediments despite steroid therapy (with or without cytotoxic agents)
- •Age over 18 with informed consent
- •Female patients of child-bearing age and male patients who agree to maintain effective birth control practice during the study
排除标准
- •Patient with abnormal liver function tests
- •Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
- •Patient who is diabetic
- •Patient who is receiving non-steroidal anti-inflammatory drugs (NSAIDs) or other agents known to influence urinary protein excretion
- •Patient is allergic or intolerant to macrolide antibiotics or tacrolimus
结局指标
主要结局
Change in 24-hour urinary protein excretion
次要结局
- Development of non-renal flare
- Development of renal flare