Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test
研究概览
简要总结
The aim of this clinical trial is to determine the effect and security of low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis.
详细描述
Focal segmental glomerular sclerosis (FSGS) is characterized by heavy proteinuria and nephritic syndrome in clinic. The major pathological change is scarring of the glomerulus that is focal and segmental. The incidence of FSGS is increasing in recent years, but no unified protocol for FSGS treatment has been provided. Corticosteroid is the primary drug for FSGS treatment in clinic. However, corticosteroid treatment has a low response rate as 20% in clinic but some severe side-effects. The side-effects of long-term corticosteroid treatment urged researchers to find more reliable and secure methods for FSGS treatment. The new immunosuppressants shed light on FSGS treatment recently. The usage of immunosuppressants to FSGS treatment is in the preliminary stage and accounts for a few problems. The main problems include the uncertainty of curative effects, the lack of large-scale clinical trial, the side-effects of long-term application, and the high recurrence rate after withdraw. FSGS is immune-induced damage, which includes abnormality of many steps in humoral immunity and cellular immunity. According to it, we designed to inhibit the immune response at multi-targets with Prednisone Combined With MMF and FK506. Thus the dosage of these drugs can be decreased to a secure level for long-term treatment while the side-effects can be controlled well. Prednisone Combined With MMF and FK506 then can be used to FSGS treatment with effectiveness and security.
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
- 16 Years 至 70 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Urinary protein≥1.0g/24h
- •Biopsy-proved FSGS
- •Age≥16years
- •Understanding of the content of this study,signing informed consent form
- •Adherence to drug taking and being able to be long-term followed up
排除标准
- •Sharp deterioration of renal function
- •Refractory hypertension
- •Secondary FSGS
- •Serious disease of liver,active stage of viral hepatitis,or AST、ALT≥2.5 times of baseline
- •Serious myelosuppression
- •Being unable to be long-term followed up
研究组 & 干预措施
prednisone, MMF and FK506
干预措施: prednisone, FK506, MMF (Drug)
prednisone
干预措施: prednisone (Drug)
结局指标
主要结局
proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test
时间窗: 16~24 weeks
次要结局
未报告次要终点
