ACEi/ARB Alone Versus ACEi/ARB Plus Steroids in the Treatment of Primary IgA Nephropathy, a RCT
试验速览
- 阶段
- 不适用
- 发起方
- 主要终点
- Serum creatinine
研究概览
简要总结
IgA nephropathy( IgAN) is the most common primary glomerulonephritis worldwide. Since the etiology of the disease is not clearly understood, no specific therapeutic strategies was defined for IgAN. Both ACEi/ARB and steroid was found to be effective in slowing the rate of disease progression, but the use of steroid was restricted because of its side effects. However, there is no evidence from RCT on the question of whether combined use of steroid with ACEi/ARB can bring more benefit to IgAN patients than ACEi/ARB alone. We therefore undertook a randomized, multicenter study to investigate the efficacy and safety profile of combined use of ACEi/ARB plus steroid compared with ACEi/ARB alone in the treatment of patients with IgAN.
详细描述
IgA nephropathy( IgAN) is the most common primary glomerulonephritis worldwide. Since the etiology of the disease is not clearly understood, no specific therapeutic strategies was defined for IgAN. In the many studies on the treatment of IgAN, both ACEi/ARB and steroid was found to be effective in slowing the rate of disease progression, but the use of steroid was restricted because of its side effects, and ACEi/ARB was considered to be the first line therapy. However, there is no evidence from RCT on the question of whether combined use of steroid with ACEi/ARB can bring more benefit to IgAN patients than ACEi/ARB alone. We therefore undertook a randomized, multicenter study to investigate the efficacy and safety profile of combined use of ACEi/ARB plus steroid compared with ACEi/ARB alone in the treatment of patients with IgAN.
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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •underwent renal biopsy within 1 year before start fo trial;
- •24 hour urinary protein excretion ranged between 1 to 7 g/d;
- •eGFR, evaluated by MDRD formula, should be higher than 30 ml/min
排除标准
- •crescentic glomerulonephritis;
- •steroid therapy subjected within 1 year before trial;
- •malignant hypertension(DBP> 130 mmHg and/or SBP> 220mmHg), resistant to anti-hypertensive agents;
- •urinary protein excretion decrease below 1 g/l after run-in period;
- •Myocardial infarction or cerebrovascular accident in 6 months preceding the trial;
- •renovascular disease;
- •diabetes mellitus;
- •Malignancy, severe liver disease, refractory infection;
- •peptic ulcer in active disease phase;
- •other contraindication to the use of ACEi/ ARB or corticosteroid;
- •alcohol abuse or drug addiction
结局指标
主要结局
Serum creatinine
24 hour urinary protein excretion
次要结局
- Urinalysis
- serum urea
- serum albumin