Phase III, Open, Randomized, Parallel-group Clinical Trial, to Evaluate the Efficacy and Safety of Treatment With Prednisone, Cyclosporine, Mycophenolic Acid Versus Prednisone and Mycophenolic Acid in Lupus Nephritis Type III-IV-V.
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- the number of complete remissions, between the triple therapy with cyclosporine-prednisone-mycophenolic acid and conventional therapy with mycophenolic acid-prednisone as induction therapy in patients with lupus nephritis type III-IV-V
研究概览
简要总结
The treatment of lupus nephritis with cyclophosphamide and steroids changed the prognosis of lupus nephritis in the early '80s. In recent years, alternative regimens have appeared in both the induction and maintenance with similar results at least to those offered by the classic pattern and possibly with fewer side effects, especially for long term. The association of prednison and mycophenolate has created large expectations to that effect, and is part of first-line therapeutic arsenal of lupus nephritis type III, IV and V.
Despite the significant advances that have led to these treatments, the likelihood of complete remission after six months remains, according to the series of 8-13% and partial remission do not exceed 60% in papers published. In the last year, two articles have been published supporting the use of triple therapy (prednisone, mycophenolate, cyclosporine) in poor prognosis of lupus nephritis with hopefully better results than those obtained previously. In this study we try to compare the effectiveness of triple therapy, the therapy is now considered standard (prednisone, mycophenolate) in patients with lupus nephritis type III-IV-V
详细描述
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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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Patients diagnosed SLE with renal type III-IV-V confirmed by renal biopsy done in the last 6 months
- •Proteinuria > 2 g/24 hours and hematuria (> 5 h / field)
- •MDRD4 eGFR > 60 ml/min/1.73m2
- •Participant is willing and able to give informed consent for participation in the study
排除标准
- •Central nervous system LES involvement or any other vital organ
- •Active infection
- •Use of mycophenolic acid, mycophenolate mofetil, cyclosporine or tacrolimus in the last 6 months
- •No adherence
- •Women of childbearing age not using appropriate contraceptive methods.
- •Positive pregnancy test
- •Malignancy or cancer history (except basal cell skin carcinomas)
- •Patient participating in another study with an investigational drug or have participated within 28 days prior to entry into this study
研究组 & 干预措施
cyclosporine+mycophenolic acid+prednison
Triple therapy
干预措施: cyclosporine +mycophenolic acid+prednison (Drug)
mycophenolic acid + prednison
Mycophenolic acid+prednison 106 weeks
干预措施: Mycophenolic Acid + prednison (Drug)
结局指标
主要结局
the number of complete remissions, between the triple therapy with cyclosporine-prednisone-mycophenolic acid and conventional therapy with mycophenolic acid-prednisone as induction therapy in patients with lupus nephritis type III-IV-V
时间窗: 36 months
Complete remission: * Proteinuria \< 0.3 g/24h * Albumin normal * eGFR \> 60 mL/min/1.73 m2
次要结局
- the number of partial and complete remissions, between triple therapy with prednisone, cyclosporine, mycophenolic acid and prednisone-mycophenolic acid.(36 months)
- the number of patients with adverse effects(36 months)
- the rate (%) of decline of proteinuria in two groups(36 months)
- the decrease in GFR (ml/min/1.73m2) in both groups(36 months)