A Randomized, Double Blinded, Placebo-controlled, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Losartan in Early Immunoglobulin A Nephropathy (IgAN) Patients
试验速览
- 阶段
- 3 期
- 入组人数
- 174
- 主要终点
- Significant proteinuria rate
研究概览
简要总结
Immunoglobulin A nephropathy (IgAN) is the most common glomerulonephritis worldwide. IgAN is progressive, particularly when patients have a significant proteinuria (proteinuria >1g/g creatinine), impaired kidney function, or elevated blood pressure. In 10 years, nearly 20-40% of these IgAN patients progress to end-stage renal disease (ESRD). Early IgAN is tentatively defined when proteinuria is insignificant and kidney function and blood pressure are normal. Patients with early IgAN rarely progress to ESRD. However, 30-40% of patients with early IgAN ultimately developed a significant proteinuria and hypertension in 10 years. Therefore, earlier intervention may be needed if it can prevent the development of a significant proteinuria and hypertension. Since angiotensin ll receptor blocker (ARB) is drug of choice in reducing proteinuria and controlling blood pressure, the investigators hypothesized that early introduction of ARB may be beneficial in preventing the significant proteinuria development in early IgAN patients. To prove the hypothesis, the investigators plan the current interventional study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven IgAN: dominant or co-dominant deposits of mesangial IgA in immunofluorescence stain
- •Age >= 19 years
- •Random urine protein-to-creatinine ratio 0.3 g/g creatinine to 1.0 g/g creatinine at visit 1
- •Estimated glomerular filtration rate >= 60 mL/min/1.73m2 at visit 1
- •People who voluntarily agreed to participate
- •People who are compliant
排除标准
- •Prevalent Hypertension: systolic blood pressure >=140 mmHg and >=90 mmHg, previous physician diagnosis of hypertension, or taking anti-hypertensive drugs
- •Prevalent Diabetes: fasting glucose >= 126 mg/dL, HbA1c >= 6.5%, taking insulin or anti-diabetic drugs, or previous physician diagnosis of diabetes
- •Previous immunosuppressive drugs use to treat IgAN
- •Secondary IgAN
- •Renin-angiotensin-aldosterone inhibitors (RASI) dependent patients (congestive heart failure, ischemic heart disease, and others)
- •hypersensitivity to RASI
- •Other chronic diseases: malignancy within 5 years, significant liver and gastrointestinal disease and other autoimmune disease
- •symptomatic orthostatic hypotension
- •People who already participated in other interventional studies or taking interventional drugs within 3 month of screening visit
- •Inappropriate people ascertained by investigator
研究组 & 干预措施
Losartan group
Losartan 50 mg daily
干预措施: Losartan group (Drug)
Placebo group
Placebo 1 pill daily which has same size, color and taste with losartan
干预措施: Placebo group (Drug)
结局指标
主要结局
Significant proteinuria rate
时间窗: 144 weeks after study started
Random urine protein-to-creatinine ratio \>= 1g/g creatinine
次要结局
- Impaired kidney function rate(48 weeks, 96 weeks, and 144 weeks after study started)
- Proteinuria remission rate(48 weeks, 96 weeks, and 144 weeks after study started)
- Hypertension development rate(48 weeks, 96 weeks, and 144 weeks after study started)